Regional Nerve Blocks to Improve Analgesia and Recovery in Older Adults Undergoing Spinal Fusion

NCT05461092 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 202305284
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This initial study is a feasibility study for implementing thoracolumbar interfascial plane, or TLIP, blocks in older adults undergoing spinal fusion. TLIP blocks are done by using anesthesia. In this case, it will be done to either side of the back where surgery will be performed. This has been shown to decrease pain the patients have post-operatively in previous research. In this study, the investigators will examine recruitment rates, completion of assessments, dropout rate, gather patient feedback, and identify barriers to performing TLIP. Further, this feasibility study will provide data to determine adequate sample size and refine methods and outcomes for a future randomized clinical trial. The ultimate goal is to perform a large, appropriately powered randomized control trial to determine the effect of TLIP blocks on pain, physical function and disability, opioid consumption, and delirium in older adult undergoing spinal fusion.

Conditions

Delirium; Pain, Back; Spinal Fusion; Thoracolumbar Interfascial Plane Block

Outcome Measures

Primary Outcomes (13)

• Numerical Rating Score

  Change in pain will be assessed using the Numerical Rating Score Questionnaire immediately before surgery and at 2, 6 and 12 weeks post-operatively.

  Change assessed from pre-surgery to 12 weeks post-operatively.

• Daily Pain Trajectory

  Change in pain will be assessed using the Daily Pain Trajectory survey each day post-operatively for 30 days.

  Change assessed from 1 day to 30 days post-operatively

• Pain Catastrophizing

  Change in pain catastrophizing and severity will be assessed using the Pain Catastrophizing scale immediately before surgery and at 2, 6, and 12 weeks post-operatively.

  Change from Pre-operation score to 12 weeks post-operatively

• Pain Fear and Avoidance

  Change in pain fear and subject avoidance will be assessed using the Pain Fear and Avoidance Questionnaire immediately before surgery and at 2, 6, and 12 weeks post-operatively.

  Change from Pre-operation score to 12 weeks post-operatively

• Pain Interference

  Change in how pain interferes with patient physical, emotional, and social functioning will be assessed using the PROMIS - Pain Interference questionnaire immediately before surgery and at 2, 6, and 12 weeks post-operatively.

  Change from Pre-operation score to 12 weeks post-operatively

• Generalized Anxiety Disorder

  Change in severity measurement of generalized anxiety disorder assessed using the Generalized Anxiety Disorder 7 item scale immediately before surgery and at 2, 6, and 12 weeks post-operatively.

  Change from pre-operation score to 12 weeks post-operatively

• Personal Health Questionnaire Depression Scale

  Change in depression will be assessed using the Personal Health Questionnaire Depression Scale measured immediately before surgery and at 2, 6, and 12 weeks post-operatively.

  Change from pre-operation score to 12 weeks post-operatively

• Oswestry disability index

  Change in disability score will be assessed using the Oswestry disability index measured immediately before surgery and at 2, 6, and 12 weeks post-operatively.

  Change from Pre-operative score to 12 weeks post-operatively

• Tampa Scale of Kinesiophobia

  Change in kinesiophobia will be assessed using the Tampa Scale of Kinesiophobia measured immediately before surgery and at 2, 6, and 12 weeks post-operatively.

  Change from Pre-operative score to 12 weeks post-operatively

• Delirium Rating Scale-Revised-98

  Change in delirium severity will be assessed using the Delirium Rating Scale-Revised-98 16 item clinician rated scale measured immediately before surgery and at 1 day, 2 days, 3 days, 2 weeks, 6 weeks, and 12 weeks post-operatively.

  Change from Pre-operative score to 12 weeks post-operatively

• 3D-CAM-S and 3D-CAM-ICU

  Change in delirium symptoms will be assessed using the 3D-CAM-S and 3D-CAM-ICU Questionnaire measured immediately before surgery and at 1 day, 2 days, 3 days, 2 weeks, 6 weeks, and 12 weeks post-operatively.

  Change from Pre-operative score to 12 weeks post-operatively

• Modified Telephone Interview of Cognitive Status

  Change in cognitive status will be assessed using the Modified Telephone Interview of cognitive Status measured immediately before surgery and at 6, and 12 weeks post-operatively.

  Change from Pre-operative score to 12 weeks post-operatively

• Saint Louis University Mental Status Examination (SLUMs)

  Change in baseline cognition will be assessed using the Saint Louis University Mental Status Examination measured immediately before surgery and at 2, 6, and 12 weeks post-operatively.

  Change from Pre-operative score to 12 weeks post-operatively.

Secondary Outcomes (7)

• Opioid Use

  Change from pre-operative score through 12 weeks post-operatively

• Opioid Side Effects and Likability Questionnaire

  Change from 1 week post-operative results to 4 weeks post-operation.

• Self-reported Adverse Events

  Change from pre-operative result through 12 weeks post-operatively.

• Length of Hospitalization

  Through study completion, 16 months

• Disposition to skilled-facilities

  Through study completion, 16 months

Study Arms (2)

Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

ACTIVE COMPARATOR

Subjects will receive standard of care anesthesia without TLIP Block of bupivicaine.

Diagnostic Test: Blood Test; Other: 3D CAM Delirium Severity Scoring; Other: Generalized Anxiety Disorder 7-item (GAD-7) scale; Other: Numerical Rating Score (NRS); Other: PROMIS-Pain Interference; Other: Oswestry Disability Index (ODI); Other: Saint Louis University Mental Status Examination (SLUMs); Other: Delirium Rating Scale-Revised-98 (DRS); Other: Telephone Interview for Cognitive Status - Modified (TICS-M); Other: Opioid Equivalents measured by Morphine Milligram Equivalents (MME); Other: Patient Health Questionnaire depression scale (PHQ-8); Other: Pain Catastrophizing; Other: Fear Avoidance Beliefs Questionnaire (FABQ); Other: Opioid Side Effects and Likeability Questionnaire; Other: Daily Pain Trajectory; Other: Tampa Scale of Kinesiophobia; Other: Quality of Recovery 15

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine

EXPERIMENTAL

Patient receives standard of care anesthesia with TLIP Block of bupivacaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.

Drug: Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine; Diagnostic Test: Blood Test; Other: 3D CAM Delirium Severity Scoring; Other: Generalized Anxiety Disorder 7-item (GAD-7) scale; Other: Numerical Rating Score (NRS); Other: PROMIS-Pain Interference; Other: Oswestry Disability Index (ODI); Other: Saint Louis University Mental Status Examination (SLUMs); Other: Delirium Rating Scale-Revised-98 (DRS); Other: Telephone Interview for Cognitive Status - Modified (TICS-M); Other: Opioid Equivalents measured by Morphine Milligram Equivalents (MME); Other: Patient Health Questionnaire depression scale (PHQ-8); Other: Pain Catastrophizing; Other: Fear Avoidance Beliefs Questionnaire (FABQ); Other: Opioid Side Effects and Likeability Questionnaire; Other: Daily Pain Trajectory; Other: Tampa Scale of Kinesiophobia; Other: Quality of Recovery 15

Interventions

Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine DRUG

Patient receives standard of care anesthesia with TLIP Block of bupivicaine (local anesthetic) intraoperatively after anesthesia administration and before spinal fusion.

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine

Blood Test DIAGNOSTIC_TEST

Blood Tests measuring inflammatory markers: IL-10, MCP-1, IL-8, IL-6, TNFa

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine; Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

3D CAM Delirium Severity Scoring OTHER

Questionnaire that will rate each symptom of delirium

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine; Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

Generalized Anxiety Disorder 7-item (GAD-7) scale OTHER

Questionnaire for screening and severity measurement of generalized anxiety disorder.

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine; Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

Numerical Rating Score (NRS) OTHER

Questionnaire assessing pain intensity

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine; Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

PROMIS-Pain Interference OTHER

Questionnaire measuring the effect of pain on patient physical, emotional, and social functioning.

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine; Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

Oswestry Disability Index (ODI) OTHER

Questionnaire assessing disability and quality of life impairment in adults with lower back pain.

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine; Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

Saint Louis University Mental Status Examination (SLUMs) OTHER

Questionnaire assessing baseline cognition.

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine; Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

Delirium Rating Scale-Revised-98 (DRS) OTHER

16 item clinician rated scale assessing delirium severity.

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine; Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

Telephone Interview for Cognitive Status - Modified (TICS-M) OTHER

Telephone interview questionnaire evaluating patient cognitive status.

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine; Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

Opioid Equivalents measured by Morphine Milligram Equivalents (MME) OTHER

The amount of opioids administered will be collected through patient self-report

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine; Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

Patient Health Questionnaire depression scale (PHQ-8) OTHER

Questionnaire used to diagnose and determine the severity measure for depressive disorders.

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine; Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

Pain Catastrophizing OTHER

Scale used to determine pain catastrophizing and it's severity.

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine; Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

Fear Avoidance Beliefs Questionnaire (FABQ) OTHER

Questionnaire used to help predict patients that have a high pain avoidance behavior.

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine; Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

Opioid Side Effects and Likeability Questionnaire OTHER

Survey determining adverse events related to opioid side effects and complications.

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine; Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

Daily Pain Trajectory OTHER

Questionnaire assessing pain location, severity, impact to quality of life, and medications used to alleviate.

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine; Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

Tampa Scale of Kinesiophobia OTHER

Questionnaire assessing Kinesiophobia

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine; Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

Quality of Recovery 15 OTHER

Questionnaire assessing postoperative quality of recovery

Standard of Care Anesthesia with Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine; Standard of Care Anesthesia without Thoracolumbar Interfascial Plane (TLIP) Block of bupivicaine.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Are 65 or older
• Indicated for lumbar spinal fusion of less than or equal to 3 levels
• Undergoing elective surgery
• no contraindications to local anesthetic or procedures
• no severe cardiac or respiratory disease
• no preexisting cognitive dysfunction/dementia

You may not qualify if:

• years old and younger
• emergency treatment
• pathologic fractures
• seeking revision surgery
• major liver or kidney dysfunction
• coexisting hematological disorder or irreversible abnormal coagulation
• patients with previous diagnosis of dementia or SLUMS score \<20
• patient unable to communicate/cooperate/language barrier
• BMI\>40
• allergy to study medications
• opioid tolerant (oral opioid intake morphine equivalent =\< 60 mg/day)
• other sources of chronic pain like fibromyalgia
• patients with associated significant CNS or respiratory disease (home oxygen requirements)
• incarcerated patients
• psychiatric illnesses preoperative neurological deficits greater than one motor group, less than three out of five motor functions

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

Related Publications (49)

• Brown CH 4th, LaFlam A, Max L, Wyrobek J, Neufeld KJ, Kebaish KM, Cohen DB, Walston JD, Hogue CW, Riley LH. Delirium After Spine Surgery in Older Adults: Incidence, Risk Factors, and Outcomes. J Am Geriatr Soc. 2016 Oct;64(10):2101-2108. doi: 10.1111/jgs.14434. Epub 2016 Oct 3.

  PMID: 27696373 BACKGROUND

• Lynch EP, Lazor MA, Gellis JE, Orav J, Goldman L, Marcantonio ER. The impact of postoperative pain on the development of postoperative delirium. Anesth Analg. 1998 Apr;86(4):781-5. doi: 10.1097/00000539-199804000-00019.

  PMID: 9539601 BACKGROUND

• Morrison RS, Magaziner J, Gilbert M, Koval KJ, McLaughlin MA, Orosz G, Strauss E, Siu AL. Relationship between pain and opioid analgesics on the development of delirium following hip fracture. J Gerontol A Biol Sci Med Sci. 2003 Jan;58(1):76-81. doi: 10.1093/gerona/58.1.m76.

  PMID: 12560416 BACKGROUND

• Wenk M, Liljenqvist U, Kaulingfrecks T, Gurlit S, Ermert T, Popping DM, Mollmann M. Intra- versus postoperative initiation of pain control via a thoracic epidural catheter for lumbar spinal fusion surgery. Minerva Anestesiol. 2018 Jul;84(7):796-802. doi: 10.23736/S0375-9393.17.12136-X. Epub 2017 Oct 4.

  PMID: 28984097 BACKGROUND

• Chen K, Wang L, Ning M, Dou L, Li W, Li Y. Evaluation of ultrasound-guided lateral thoracolumbar interfascial plane block for postoperative analgesia in lumbar spine fusion surgery: a prospective, randomized, and controlled clinical trial. PeerJ. 2019 Oct 28;7:e7967. doi: 10.7717/peerj.7967. eCollection 2019.

  PMID: 31681518 BACKGROUND

• Ye Y, Bi Y, Ma J, Liu B. Thoracolumbar interfascial plane block for postoperative analgesia in spine surgery: A systematic review and meta-analysis. PLoS One. 2021 May 21;16(5):e0251980. doi: 10.1371/journal.pone.0251980. eCollection 2021.

  PMID: 34019598 BACKGROUND

• Deyo RA, Weinstein JN. Low back pain. N Engl J Med. 2001 Feb 1;344(5):363-70. doi: 10.1056/NEJM200102013440508. No abstract available.

  PMID: 11172169 BACKGROUND

• Cassidy JD, Carroll LJ, Cote P. The Saskatchewan health and back pain survey. The prevalence of low back pain and related disability in Saskatchewan adults. Spine (Phila Pa 1976). 1998 Sep 1;23(17):1860-6; discussion 1867. doi: 10.1097/00007632-199809010-00012.

  PMID: 9762743 BACKGROUND

• Khalifeh JM, Dibble CF, Hawasli AH, Ray WZ. Patient-Reported Outcomes Measurement Information System physical function and pain interference in spine surgery. J Neurosurg Spine. 2019 Apr 26;31(2):165-174. doi: 10.3171/2019.2.SPINE181237. Print 2019 Aug 1.

  PMID: 31026819 BACKGROUND

• Khanna AK, Bergese SD, Jungquist CR, Morimatsu H, Uezono S, Lee S, Ti LK, Urman RD, McIntyre R Jr, Tornero C, Dahan A, Saager L, Weingarten TN, Wittmann M, Auckley D, Brazzi L, Le Guen M, Soto R, Schramm F, Ayad S, Kaw R, Di Stefano P, Sessler DI, Uribe A, Moll V, Dempsey SJ, Buhre W, Overdyk FJ; PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) Group Collaborators. Prediction of Opioid-Induced Respiratory Depression on Inpatient Wards Using Continuous Capnography and Oximetry: An International Prospective, Observational Trial. Anesth Analg. 2020 Oct;131(4):1012-1024. doi: 10.1213/ANE.0000000000004788.

  PMID: 32925318 BACKGROUND

• Vila H Jr, Smith RA, Augustyniak MJ, Nagi PA, Soto RG, Ross TW, Cantor AB, Strickland JM, Miguel RV. The efficacy and safety of pain management before and after implementation of hospital-wide pain management standards: is patient safety compromised by treatment based solely on numerical pain ratings? Anesth Analg. 2005 Aug;101(2):474-480. doi: 10.1213/01.ANE.0000155970.45321.A8.

  PMID: 16037164 BACKGROUND

• Rakel BA, Zimmerman BM, Geasland K, Embree J, Clark CR, Noiseux NO, Callaghan JJ, Herr K, Walsh D, Sluka KA. Transcutaneous electrical nerve stimulation for the control of pain during rehabilitation after total knee arthroplasty: A randomized, blinded, placebo-controlled trial. Pain. 2014 Dec;155(12):2599-2611. doi: 10.1016/j.pain.2014.09.025. Epub 2014 Sep 28.

  PMID: 25270585 BACKGROUND

• Coronado RA, George SZ, Devin CJ, Wegener ST, Archer KR. Pain Sensitivity and Pain Catastrophizing Are Associated With Persistent Pain and Disability After Lumbar Spine Surgery. Arch Phys Med Rehabil. 2015 Oct;96(10):1763-70. doi: 10.1016/j.apmr.2015.06.003. Epub 2015 Jun 20.

  PMID: 26101845 BACKGROUND

• Dunn LK, Durieux ME, Fernandez LG, Tsang S, Smith-Straesser EE, Jhaveri HF, Spanos SP, Thames MR, Spencer CD, Lloyd A, Stuart R, Ye F, Bray JP, Nemergut EC, Naik BI. Influence of catastrophizing, anxiety, and depression on in-hospital opioid consumption, pain, and quality of recovery after adult spine surgery. J Neurosurg Spine. 2018 Jan;28(1):119-126. doi: 10.3171/2017.5.SPINE1734. Epub 2017 Nov 10.

  PMID: 29125426 BACKGROUND

• Nwankwo VC, Jiranek WA, Green CL, Allen KD, George SZ, Bettger JP. Resilience and pain catastrophizing among patients with total knee arthroplasty: a cohort study to examine psychological constructs as predictors of post-operative outcomes. Health Qual Life Outcomes. 2021 May 1;19(1):136. doi: 10.1186/s12955-021-01772-2.

  PMID: 33933091 BACKGROUND

• Sanders RD, Pandharipande PP, Davidson AJ, Ma D, Maze M. Anticipating and managing postoperative delirium and cognitive decline in adults. BMJ. 2011 Jul 20;343:d4331. doi: 10.1136/bmj.d4331. No abstract available.

  PMID: 21775401 BACKGROUND

• Ely EW, Gautam S, Margolin R, Francis J, May L, Speroff T, Truman B, Dittus R, Bernard R, Inouye SK. The impact of delirium in the intensive care unit on hospital length of stay. Intensive Care Med. 2001 Dec;27(12):1892-900. doi: 10.1007/s00134-001-1132-2. Epub 2001 Nov 8.

  PMID: 11797025 BACKGROUND

• Mason SE, Noel-Storr A, Ritchie CW. The impact of general and regional anesthesia on the incidence of post-operative cognitive dysfunction and post-operative delirium: a systematic review with meta-analysis. J Alzheimers Dis. 2010;22 Suppl 3:67-79. doi: 10.3233/JAD-2010-101086.

  PMID: 20858956 BACKGROUND

• Fong HK, Sands LP, Leung JM. The role of postoperative analgesia in delirium and cognitive decline in elderly patients: a systematic review. Anesth Analg. 2006 Apr;102(4):1255-66. doi: 10.1213/01.ane.0000198602.29716.53.

  PMID: 16551934 BACKGROUND

• Leung JM, Sands LP, Lim E, Tsai TL, Kinjo S. Does preoperative risk for delirium moderate the effects of postoperative pain and opiate use on postoperative delirium? Am J Geriatr Psychiatry. 2013 Oct;21(10):946-56. doi: 10.1016/j.jagp.2013.01.069. Epub 2013 May 6.

  PMID: 23659900 BACKGROUND

• Vaurio LE, Sands LP, Wang Y, Mullen EA, Leung JM. Postoperative delirium: the importance of pain and pain management. Anesth Analg. 2006 Apr;102(4):1267-73. doi: 10.1213/01.ane.0000199156.59226.af.

  PMID: 16551935 BACKGROUND

• Berger M, Terrando N, Smith SK, Browndyke JN, Newman MF, Mathew JP. Neurocognitive Function after Cardiac Surgery: From Phenotypes to Mechanisms. Anesthesiology. 2018 Oct;129(4):829-851. doi: 10.1097/ALN.0000000000002194.

  PMID: 29621031 BACKGROUND

• Hand WR, Taylor JM, Harvey NR, Epperson TI, Gunselman RJ, Bolin ED, Whiteley J. Thoracolumbar interfascial plane (TLIP) block: a pilot study in volunteers. Can J Anaesth. 2015 Nov;62(11):1196-200. doi: 10.1007/s12630-015-0431-y. Epub 2015 Jul 7.

  PMID: 26149600 BACKGROUND

• Garg B, Ahuja K, Khanna P, Sharan AD. Regional Anesthesia for Spine Surgery. Clin Spine Surg. 2021 Jun 1;34(5):163-170. doi: 10.1097/BSD.0000000000001096. Epub 2020 Oct 9.

  PMID: 33044273 BACKGROUND

• Bicak M, Aktas U, Salik F, Akelma H, Bicak EA, Kaya S. Comparison of Thoracolumbar Interfascial Plane Block with the Application of Local Anesthesia in the Management of Postoperative Pain in Patients with Lumbar Disc Surgery. Turk Neurosurg. 2021;31(5):757-762. doi: 10.5137/1019-5149.JTN.33017-20.2.

  PMID: 34374980 BACKGROUND

• Ueshima H, Hara E, Otake H. RETRACTED: Thoracolumbar interfascial plane block provides effective perioperative pain relief for patients undergoing lumbar spinal surgery; a prospective, randomized and double blinded trial. J Clin Anesth. 2019 Dec;58:12-17. doi: 10.1016/j.jclinane.2019.04.026. Epub 2019 Apr 25.

  PMID: 31029989 BACKGROUND

• Ohgoshi Y, Namiki R, Kori S, Matsukawa M. The use of ultrasound-guided thoracolumbar interfascial plane block for multi-level lumbar spinal surgery. J Clin Anesth. 2017 Feb;37:162. doi: 10.1016/j.jclinane.2016.12.025. Epub 2017 Jan 10. No abstract available.

  PMID: 28235513 BACKGROUND

• Tseng V, Xu JL. Erector Spinae Plane Block for Postoperative Analgesia in Lumbar Spine Surgery: Is There a Better Option? J Neurosurg Anesthesiol. 2021 Jan;33(1):92. doi: 10.1097/ANA.0000000000000631. No abstract available.

  PMID: 31343504 BACKGROUND

• Ueshima H. Retraction notice to "Lumbar thoracolumbar interfascial plane block provides effective analgesia for spondylosis" [J. Clin. Anesth. 57 (2019)37]. J Clin Anesth. 2022 Aug;79:110762. doi: 10.1016/j.jclinane.2022.110762. Epub 2022 Apr 4. No abstract available.

  PMID: 35393185 BACKGROUND

• Morgenstern C, Ramirez-Paesano C, Juanola Galceran A, Morgenstern R. Thoracolumbar Interfascial Plane Block Results in Opioid-Free Postoperative Recovery After Percutaneous/Endoscopic Transforaminal Lumbar Interbody Fusion Surgery. World Neurosurg. 2021 Sep;153:e473-e480. doi: 10.1016/j.wneu.2021.06.152. Epub 2021 Jul 6.

  PMID: 34242827 BACKGROUND

• Gao H, Ma HJ, Li YJ, Yin C, Li Z. Prevalence and risk factors of postoperative delirium after spinal surgery: a meta-analysis. J Orthop Surg Res. 2020 Apr 9;15(1):138. doi: 10.1186/s13018-020-01651-4.

  PMID: 32272939 BACKGROUND

• Farag E, Seif J. Thoracolumbar interfascial block (TLIP): A new technique of interfascial plane blocks. J Clin Anesth. 2020 May;61:109640. doi: 10.1016/j.jclinane.2019.109640. Epub 2019 Oct 28. No abstract available.

  PMID: 31672416 BACKGROUND

• Shin C, Lee SH, Han KM, Yoon HK, Han C. Comparison of the Usefulness of the PHQ-8 and PHQ-9 for Screening for Major Depressive Disorder: Analysis of Psychiatric Outpatient Data. Psychiatry Investig. 2019 Apr;16(4):300-305. doi: 10.30773/pi.2019.02.01. Epub 2019 Apr 24.

  PMID: 31042692 BACKGROUND

• Von Korff M, Saunders K, Thomas Ray G, Boudreau D, Campbell C, Merrill J, Sullivan MD, Rutter CM, Silverberg MJ, Banta-Green C, Weisner C. De facto long-term opioid therapy for noncancer pain. Clin J Pain. 2008 Jul-Aug;24(6):521-7. doi: 10.1097/AJP.0b013e318169d03b.

  PMID: 18574361 BACKGROUND

• Ahn SH, Choi JH, Im CS, Kim TS, Kim JL. A Comparison of the Severe Cognitive Impairment Rating Scale With the Mini-Mental State Examination and Delirium Rating Scale-Revised-98 for Delirium: A Cross-sectional Study. Psychosomatics. 2017 Nov-Dec;58(6):643-651. doi: 10.1016/j.psym.2017.08.002. Epub 2017 Aug 5.

  PMID: 29032807 BACKGROUND

• Marcantonio ER, Ngo LH, O'Connor M, Jones RN, Crane PK, Metzger ED, Inouye SK. 3D-CAM: derivation and validation of a 3-minute diagnostic interview for CAM-defined delirium: a cross-sectional diagnostic test study. Ann Intern Med. 2014 Oct 21;161(8):554-61. doi: 10.7326/M14-0865.

  PMID: 25329203 BACKGROUND

• Ely EW, Inouye SK, Bernard GR, Gordon S, Francis J, May L, Truman B, Speroff T, Gautam S, Margolin R, Hart RP, Dittus R. Delirium in mechanically ventilated patients: validity and reliability of the confusion assessment method for the intensive care unit (CAM-ICU). JAMA. 2001 Dec 5;286(21):2703-10. doi: 10.1001/jama.286.21.2703.

  PMID: 11730446 BACKGROUND

• Olbert M, Eckert S, Morgeli R, Kruppa J, Spies CD. Validation of 3-minute diagnostic interview for CAM-defined Delirium to detect postoperative delirium in the recovery room: A prospective diagnostic study. Eur J Anaesthesiol. 2019 Sep;36(9):683-687. doi: 10.1097/EJA.0000000000001048.

  PMID: 31306183 BACKGROUND

• Tariq SH, Tumosa N, Chibnall JT, Perry MH 3rd, Morley JE. Comparison of the Saint Louis University mental status examination and the mini-mental state examination for detecting dementia and mild neurocognitive disorder--a pilot study. Am J Geriatr Psychiatry. 2006 Nov;14(11):900-10. doi: 10.1097/01.JGP.0000221510.33817.86.

  PMID: 17068312 BACKGROUND

• Yadeau JT, Liu SS, Rade MC, Marcello D, Liguori GA. Performance characteristics and validation of the Opioid-Related Symptom Distress Scale for evaluation of analgesic side effects after orthopedic surgery. Anesth Analg. 2011 Aug;113(2):369-77. doi: 10.1213/ANE.0b013e31821ae3f7. Epub 2011 Apr 27.

  PMID: 21525182 BACKGROUND

• Jamison RN, Dorado K, Mei A, Edwards RR, Martel MO. Influence of opioid-related side effects on disability, mood, and opioid misuse risk among patients with chronic pain in primary care. Pain Rep. 2017 Mar 6;2(2):e589. doi: 10.1097/PR9.0000000000000589. eCollection 2017 Mar.

  PMID: 29392205 BACKGROUND

• Glare P, Walsh D, Sheehan D. The adverse effects of morphine: a prospective survey of common symptoms during repeated dosing for chronic cancer pain. Am J Hosp Palliat Care. 2006 Jun-Jul;23(3):229-35. doi: 10.1177/1049909106289068.

  PMID: 17060284 BACKGROUND

• Dailey DL, Vance CGT, Rakel BA, Zimmerman MB, Embree J, Merriwether EN, Geasland KM, Chimenti R, Williams JM, Golchha M, Crofford LJ, Sluka KA. Transcutaneous Electrical Nerve Stimulation Reduces Movement-Evoked Pain and Fatigue: A Randomized, Controlled Trial. Arthritis Rheumatol. 2020 May;72(5):824-836. doi: 10.1002/art.41170. Epub 2020 Mar 18.

  PMID: 31738014 BACKGROUND

• Driban JB, Morgan N, Price LL, Cook KF, Wang C. Patient-Reported Outcomes Measurement Information System (PROMIS) instruments among individuals with symptomatic knee osteoarthritis: a cross-sectional study of floor/ceiling effects and construct validity. BMC Musculoskelet Disord. 2015 Sep 14;16:253. doi: 10.1186/s12891-015-0715-y.

  PMID: 26369412 BACKGROUND

• Quan H, Li B, Couris CM, Fushimi K, Graham P, Hider P, Januel JM, Sundararajan V. Updating and validating the Charlson comorbidity index and score for risk adjustment in hospital discharge abstracts using data from 6 countries. Am J Epidemiol. 2011 Mar 15;173(6):676-82. doi: 10.1093/aje/kwq433. Epub 2011 Feb 17.

  PMID: 21330339 BACKGROUND

• Sim J, Lewis M. The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J Clin Epidemiol. 2012 Mar;65(3):301-8. doi: 10.1016/j.jclinepi.2011.07.011. Epub 2011 Dec 9.

  PMID: 22169081 BACKGROUND

• Asher AL, Kerezoudis P, Mummaneni PV, Bisson EF, Glassman SD, Foley KT, Slotkin JR, Potts EA, Shaffrey ME, Shaffrey CI, Coric D, Knightly JJ, Park P, Fu KM, Devin CJ, Archer KR, Chotai S, Chan AK, Virk MS, Bydon M. Defining the minimum clinically important difference for grade I degenerative lumbar spondylolisthesis: insights from the Quality Outcomes Database. Neurosurg Focus. 2018 Jan;44(1):E2. doi: 10.3171/2017.10.FOCUS17554.

  PMID: 29290132 BACKGROUND

• Goudman L, Smedt A, Forget P, Moens M. Determining the Minimal Clinical Important Difference for Medication Quantification Scale III and Morphine Milligram Equivalents in Patients with Failed Back Surgery Syndrome. J Clin Med. 2020 Nov 21;9(11):3747. doi: 10.3390/jcm9113747.

  PMID: 33233343 BACKGROUND

• Brock JL, Jain N, Phillips FM, Malik AT, Khan SN. Postoperative opioid cessation rates based on preoperative opioid use: analysis of common orthopaedic procedures. Bone Joint J. 2019 Dec;101-B(12):1570-1577. doi: 10.1302/0301-620X.101B12.BJJ-2019-0080.R2.

  PMID: 31787005 BACKGROUND

MeSH Terms

Conditions

Delirium; Back Pain

Interventions

Hematologic Tests; Patient Health Questionnaire; Weights and Measures; Interviews as Topic

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Pain

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Psychological Tests; Behavioral Disciplines and Activities; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Catherine R Olinger, MD

  Clinical Assistant Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex R Coffman, BS

CONTACT

319-353-8996; alex-coffman@uiowa.edu

Catherine R Olinger, MD

CONTACT

319-384-5892; catherine-olinger@uiowa.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both patient (participant) and surgeon will be masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: July 15, 2022
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)