GA + ESP vs. SA + ESP in Lumbar Decompression Surgeries

NCT05444751 | Enrolling By Invitation Phase 3 DMC FDA Drug

• 1 other identifier: 2020-2478
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the optimal anesthetic routine for lumbar decompression surgery. General Anesthesia is the standard of care in spine surgery. Spinal anesthesia in decompressive procedures can be the new standard of care. Recently, it has been found that regional analgesia is option that has been shown to improve pain and opioid-related outcomes after spine surgery, but has not yet been studied in combination with spinal anesthesia. This is study that consists of two groups: standard of care general anesthesia with a nerve block and a spinal anesthesia with nerve block. Patients are randomized to either of the two groups. There will be 71 patients enrolled in each group for this study.

Conditions

Lumbar Disc Herniation; Lumbar Disc Disease; Lumbar Radiculopathy

Keywords

Degenerative Disc Disease; Lumbar Spine

Outcome Measures

Primary Outcomes (1)

• QoR15 survey scores

  The primary outcome is the difference in the quality of recovery-15 (QoR15) score between the groups at each timepoint (before surgery, after surgery, and at their first 2 week follow-up visit). For this survey, a high number represents something that occurs often, while a low number indicates something that rarely or never occurs. Depending on the category/question asked, this may be good or bad. The questions on the survey will be split and compared so that for one subset of questions a high number is good while the opposite is true for the other subset of questions. This will be done so the comparison between groups is more accurate and meaningful.

  The QoR15 survey will be assessed preoperatively (in holding area). It will be assessed again immediately after surgery in the PACU and then at 2-weeks postoperatively at the patient's first follow-up visits

Secondary Outcomes (5)

• NRS Survey Pain Scores

  The NRS will be assessed preoperatively (in holding area), postoperatively in PACU, and 2 weeks postoperatively at the patient's first follow-up

• Opioid Consumption

  From surgery through 24 hours postoperatively

• Anesthetic(s) Time

  Intraoperatively

• Surgical Duration

  Intraoperatively

• Complications

  Length of stay at the hospital (up to 3 days postoperatively)

Study Arms (2)

SA + ESP Block

EXPERIMENTAL

Spinal Anesthesia: Patients will be provided with iv sedation, if desired, to facilitate placement of spinal anesthetic. Midazolam (2-5mg, iv), ketamine (up to 20 mg, lv) and/or propofol (0.1-0.2 mg/kg) will be permitted.

Drug: SA + ESP

GA + ESP Block

ACTIVE COMPARATOR

General anesthesia: induction of general anesthesia to facilitate endotracheal intubation: fentanyl (up to 2μg.kg.min-1), propofol (1-2 mg.kg-1), vecuronium (1-2 mg.kg-1).

Drug: General anesthetic

Interventions

General anesthetic DRUG

Maintenance of general anesthesia: propofol infusion (50-150 μg.kg.min-1); ketamine infusion (up to 50 mg total); and inhaled anesthetic agent (isoflurane or sevoflurane) up to 0.5 MAC. N20 is not permitted. Emergence from general anesthesia: N20 may be used during closure of the surgical incision to facilitate rapid emergence.

Also known as: GA + ESP

GA + ESP Block

SA + ESP DRUG

The choice of local anesthetic for spinal anesthesia will be confirmed after consultation with the attending surgeon to determine duration of surgery. For expected surgical times less than 90 minutes, up to 4 mL 1.5% mepivacaine (60 mg) will be used. Where the anticipated surgical duration is longer than 90 minutes, 2 mL 0.5% bupivacaine (10 mg) may be substituted. After patient (prone) positioning, maintenance of sedation will be achieved with a target RASS score of 0 to -1. Propofol (25-50 μg.kg.min-1) and ketamine (up to 50 mg total dose) infusions will be titrated to effect. Intermittent boluses of propofol (10-20mg) may be used to achieve the desired sedation, as needed. Patients will be offered to option of awake surgery, where no sedation will be provided, if preferred. Patients will be informed that at any time before or during the procedure, they may change their mind, and receive sedation.

Also known as: Erector Spinae Block

SA + ESP Block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients from the ages 18- 80 years
• Patients with one or two-level microdiscectomy, laminotomy, or foraminotomy - prior spine surgery is allowed only if surgery was preformed at other levels.
• Able to follow study protocol
• Able to provide informed consent

You may not qualify if:

• Surgery with planned need for postoperative surgical drain.
• Allergies of contraindication to any study anesthetic or analgesic medications.
• Morbid obesity, defined as BMI \> 35 kg/m2.
• Involved in the study of another investigational product that may affect the outcome.

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (32)

• McLain RF, Kalfas I, Bell GR, Tetzlaff JE, Yoon HJ, Rana M. Comparison of spinal and general anesthesia in lumbar laminectomy surgery: a case-controlled analysis of 400 patients. J Neurosurg Spine. 2005 Jan;2(1):17-22. doi: 10.3171/spi.2005.2.1.0017.

  PMID: 15658121 BACKGROUND

• Kilic ET, Naderi S. Effects of Anesthesia Protocol on Perioperative Outcomes and Costs of Lumbar Microdiscectomies. Turk Neurosurg. 2019;29(6):843-850. doi: 10.5137/1019-5149.JTN.25737-18.4.

  PMID: 30984998 BACKGROUND

• Melvin JP, Schrot RJ, Chu GM, Chin KJ. Low thoracic erector spinae plane block for perioperative analgesia in lumbosacral spine surgery: a case series. Can J Anaesth. 2018 Sep;65(9):1057-1065. doi: 10.1007/s12630-018-1145-8. Epub 2018 Apr 27.

  PMID: 29704223 BACKGROUND

• Marks R. Keeping patient awake during spine surgery is cutting recovery time in half. https://www.ucsf.edu/news/2019/03/413446/spine-surgery-while-patients-are-awake-speeds-healing Accessed 1/24/2020

  BACKGROUND

• Harbers C. Duke spine surgeon offers awake surgery to patients. https://medschool.duke.edu/about-us/news-and-communications/som-magnify/duke-spine-surgeon-offers-awake-surgery-patients Accessed 1/24/2020

  BACKGROUND

• Kara I, Celik JB, Bahar OC. Comparison of spinal and general anesthesia in lumbar disc surgery. Journal of Neurological Sciences (Turkish) 28:487-496, 2011 9.

  BACKGROUND

• McLain RF, Tetzlaff JE, Bell GR, Uwe-Lewandrowski K, Yoon HJ, Rana M. Microdiscectomy: spinal anesthesia offers optimal results in general patient population. J Surg Orthop Adv. 2007 Spring;16(1):5-11.

  PMID: 17371640 BACKGROUND

• Meng T, Zhong Z, Meng L. Impact of spinal anaesthesia vs. general anaesthesia on peri-operative outcome in lumbar spine surgery: a systematic review and meta-analysis of randomised, controlled trials. Anaesthesia. 2017 Mar;72(3):391-401. doi: 10.1111/anae.13702. Epub 2016 Oct 22.

  PMID: 27770448 BACKGROUND

• Dagistan Y, Okmen K, Dagistan E, Guler A, Ozkan N. Lumbar Microdiscectomy Under Spinal and General Anesthesia: A Comparative Study. Turk Neurosurg. 2015;25(5):685-9. doi: 10.5137/1019-5149.JTN.10300-14.1.

  PMID: 26442531 BACKGROUND

• Demirel CB, Kalayci M, Ozkocak I, Altunkaya H, Ozer Y, Acikgoz B. A prospective randomized study comparing perioperative outcome variables after epidural or general anesthesia for lumbar disc surgery. J Neurosurg Anesthesiol. 2003 Jul;15(3):185-92. doi: 10.1097/00008506-200307000-00005.

  PMID: 12826965 BACKGROUND

• Dhall S, Gonzalez A, Jallo G, et al.

  BACKGROUND

• Krause KL, Cheaney Ii B, Obayashi JT, Kawamoto A, Than KD. Intraoperative neuromonitoring for one-level lumbar discectomies is low yield and cost-ineffective. J Clin Neurosci. 2020 Jan;71:97-100. doi: 10.1016/j.jocn.2019.08.116. Epub 2019 Sep 5.

  PMID: 31495654 BACKGROUND

• Pajewski TN, Arlet V, Phillips LH. Current approach on spinal cord monitoring: the point of view of the neurologist, the anesthesiologist and the spine surgeon. Eur Spine J. 2007 Nov;16 Suppl 2(Suppl 2):S115-29. doi: 10.1007/s00586-007-0419-6. Epub 2007 Jul 10.

  PMID: 17619913 BACKGROUND

• Memtsoudis SG, Cozowicz C, Bekeris J, Bekere D, Liu J, Soffin EM, Mariano ER, Johnson RL, Hargett MJ, Lee BH, Wendel P, Brouillette M, Go G, Kim SJ, Baaklini L, Wetmore D, Hong G, Goto R, Jivanelli B, Argyra E, Barrington MJ, Borgeat A, De Andres J, Elkassabany NM, Gautier PE, Gerner P, Gonzalez Della Valle A, Goytizolo E, Kessler P, Kopp SL, Lavand'Homme P, MacLean CH, Mantilla CB, MacIsaac D, McLawhorn A, Neal JM, Parks M, Parvizi J, Pichler L, Poeran J, Poultsides LA, Sites BD, Stundner O, Sun EC, Viscusi ER, Votta-Velis EG, Wu CL, Ya Deau JT, Sharrock NE. Anaesthetic care of patients undergoing primary hip and knee arthroplasty: consensus recommendations from the International Consensus on Anaesthesia-Related Outcomes after Surgery group (ICAROS) based on a systematic review and meta-analysis. Br J Anaesth. 2019 Sep;123(3):269-287. doi: 10.1016/j.bja.2019.05.042. Epub 2019 Jul 24.

  PMID: 31351590 BACKGROUND

• Attari MA, Mirhosseini SA, Honarmand A, Safavi MR. Spinal anesthesia versus general anesthesia for elective lumbar spine surgery: A randomized clinical trial. J Res Med Sci. 2011 Apr;16(4):524-9.

  PMID: 22091269 BACKGROUND

• Greenbarg PE, Brown MD, Pallares VS, Tompkins JS, Mann NH. Epidural anesthesia for lumbar spine surgery. J Spinal Disord. 1988;1(2):139-43.

  PMID: 2980070 BACKGROUND

• Hassi N, Badaoui R, Cagny-Bellet A, Sifeddine S, Ossart M. [Spinal anesthesia for disk herniation and lumbar laminectomy. Apropos of 77 cases]. Cah Anesthesiol. 1995;43(1):21-5. French.

  PMID: 7671051 BACKGROUND

• Jellish WS, Thalji Z, Stevenson K, Shea J. A prospective randomized study comparing short- and intermediate-term perioperative outcome variables after spinal or general anesthesia for lumbar disk and laminectomy surgery. Anesth Analg. 1996 Sep;83(3):559-64. doi: 10.1097/00000539-199609000-00021.

  PMID: 8780281 BACKGROUND

• Riegel B, Alibert F, Becq MC, Duckert I, Krivosic-Horber R. [Lumbar disk herniation with surgical option: general versus local anesthesia. Round table]. Agressologie. 1994;34 Spec No 1:33-7. French.

  PMID: 7818012 BACKGROUND

• Tetzlaff JE, Baird BA, Yoon HJ. Spinal anesthesia with plain bupivicaine for lumbar spine surgery. Can J Anaesth. 1990 May;37(4 Pt 2):S61. No abstract available.

  PMID: 2361303 BACKGROUND

• Tetzlaff JE, O'Hara J, Bell G, Grimm K, Yoon HJ. Influence of baricity on the outcome of spinal anesthesia with bupivacaine for lumbar spine surgery. Reg Anesth. 1995 Nov-Dec;20(6):533-7.

  PMID: 8608073 BACKGROUND

• Koekemoer AM, Henkel C, Greenhill LJ, Dey A, van Breugel W, Codella C, Antonucci R. A water-vapour giga-maser in the active galaxy TXFS2226-184. Nature. 1995 Dec 14;378(6558):697-9. doi: 10.1038/378697a0.

  PMID: 7501016 BACKGROUND

• Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.

  PMID: 30292068 BACKGROUND

• Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11.

  PMID: 28188621 BACKGROUND

• Brandão J, Mamôru T: Sakae Erector Spine Plane Block in Different Surgeries. J Anes Perio Manag 4: 005

  BACKGROUND

• Almeida CR, Oliveira AR, Cunha P. Continuous Bilateral Erector of Spine Plane Block at T8 for Extensive Lumbar Spine Fusion Surgery: Case Report. Pain Pract. 2019 Jun;19(5):536-540. doi: 10.1111/papr.12774. Epub 2019 Mar 15.

  PMID: 30758122 BACKGROUND

• Chin KJ, Lewis S. Opioid-free Analgesia for Posterior Spinal Fusion Surgery Using Erector Spinae Plane (ESP) Blocks in a Multimodal Anesthetic Regimen. Spine (Phila Pa 1976). 2019 Mar 15;44(6):E379-E383. doi: 10.1097/BRS.0000000000002855.

  PMID: 30180150 BACKGROUND

• Singh S, Chaudhary NK. Bilateral Ultasound Guided Erector Spinae Plane Block for Postoperative Pain Management in Lumbar Spine Surgery: A Case Series. J Neurosurg Anesthesiol. 2019 Jul;31(3):354. doi: 10.1097/ANA.0000000000000518. No abstract available.

  PMID: 29965831 BACKGROUND

• Ueshima H, Inagaki M, Toyone T, Otake H. Efficacy of the Erector Spinae Plane Block for Lumbar Spinal Surgery: A Retrospective Study. Asian Spine J. 2019 Apr;13(2):254-257. doi: 10.31616/asj.2018.0114. Epub 2018 Nov 15.

  PMID: 30424594 BACKGROUND

• Yayik AM, Cesur S, Ozturk F, Ahiskalioglu A, Ay AN, Celik EC, Karaavci NC. Postoperative Analgesic Efficacy of the Ultrasound-Guided Erector Spinae Plane Block in Patients Undergoing Lumbar Spinal Decompression Surgery: A Randomized Controlled Study. World Neurosurg. 2019 Jun;126:e779-e785. doi: 10.1016/j.wneu.2019.02.149. Epub 2019 Mar 8.

  PMID: 30853517 BACKGROUND

• Singh S, Choudhary NK, Lalin D, Verma VK. Bilateral Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Lumbar Spine Surgery: A Randomized Control Trial. J Neurosurg Anesthesiol. 2020 Oct;32(4):330-334. doi: 10.1097/ANA.0000000000000603.

  PMID: 31033625 BACKGROUND

• Soffin et al, 2021, in prep, personal communication

  BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Displacement; Intervertebral disc disease; Radiculopathy; Intervertebral Disc Degeneration

Interventions

Anesthetics, General; Parapsychology

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Behavioral Sciences; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: July 6, 2022
• Study Start: March 22, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-01

Locations

US (1)