Erector Spinae Plane Block (ESPB): in Patients Undergoing Surgery Through a Flank or Anterior Subcostal Incision.

NCT03691935 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: STUDY00008663
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Using a randomized double-blinded study design, the study goal is to evaluate the superiority of Erector Spinae Plane block (ESPB) in the peri-operative pain management of patients undergoing surgery through a flank or anterior subcostal incision as compared to the standard of care of using IV and oral opiates.

Conditions

Nephrectomy; Partial Nephrectomy; Incision Site Discomfort

Keywords

kidney; surgery; analgesia; surgical incision; opioid sparing; flank pain; local anesthesia

Outcome Measures

Primary Outcomes (1)

• Pain Scores Using the Visual Analogue Pain Scale From Zero Pain to Level Ten Pain

  Data will be collected via the electronic medical record and begin following patient randomization. The Visual Analogue Scale pain scales will be administered and collected on Post Operative Days 1, 2 and 3. Minimum value = 0 No Pain, Maximum value = 10 Worst possible, unbearable, excruciating pain

  Aggregate pain scores for average length of hospital stay which is 3 days

Study Arms (2)

Ropivicaine

EXPERIMENTAL

Erector Spinae Block of 20ml 0.5% ropivicaine bolus, connected to a pump containing 0.2% ropivicaine receiving 15ml every 3 hrs.

Drug: Ropivacaine

Normal Saline

SHAM COMPARATOR

Erector Spinae Block of 20ml normal saline placebo bolus, then connected to pump of normal saline receiving 15ml every 3 hrs.

Drug: Normal saline

Interventions

Ropivacaine DRUG

Erector Spinae Block with ropivacaine infusion with standard of care analgesics for perioperative pain control

Also known as: Naropin

Ropivicaine

Normal saline DRUG

Erector Spinae Block with saline infusion with standard of care analgesics for for perioperative pain control

Also known as: Sham anesthetic

Normal Saline

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consenting adults age 18-85
• American Society of Anesthesiologists (ASA) Physical Status classification I to III
• Planned to be hospitalized for at least 24 hours post-op
• Cognitive capacity to use the visual analogic scale (VAS) and complete the patient satisfaction survey

You may not qualify if:

• Patient refusal
• Patients with allergies to local anesthetics or opiates (hydromorphone or oxycodone)
• Scoliosis
• Patients with chronic pain syndromes or who are on chronic pain medications/other neurologic medication of more than 3 months or whom have neuromodulators/stimulators
• Concurrent surgeries requiring additional incisions on the body

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (11)

• Sharma V, Margreiter M. Partial nephrectomy: is there still a need for open surgery? Curr Urol Rep. 2013 Feb;14(1):1-4. doi: 10.1007/s11934-012-0297-2.

  PMID: 23233109 BACKGROUND

• Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.

  PMID: 23392233 BACKGROUND

• Gerbershagen HJ, Pogatzki-Zahn E, Aduckathil S, Peelen LM, Kappen TH, van Wijck AJ, Kalkman CJ, Meissner W. Procedure-specific risk factor analysis for the development of severe postoperative pain. Anesthesiology. 2014 May;120(5):1237-45. doi: 10.1097/ALN.0000000000000108.

  PMID: 24356102 BACKGROUND

• de Beer Jde V, Winemaker MJ, Donnelly GA, Miceli PC, Reiz JL, Harsanyi Z, Payne LW, Darke AC. Efficacy and safety of controlled-release oxycodone and standard therapies for postoperative pain after knee or hip replacement. Can J Surg. 2005 Aug;48(4):277-83.

  PMID: 16149361 BACKGROUND

• Recart A, Duchene D, White PF, Thomas T, Johnson DB, Cadeddu JA. Efficacy and safety of fast-track recovery strategy for patients undergoing laparoscopic nephrectomy. J Endourol. 2005 Dec;19(10):1165-9. doi: 10.1089/end.2005.19.1165.

  PMID: 16359206 BACKGROUND

• Watcha MF, Issioui T, Klein KW, White PF. Costs and effectiveness of rofecoxib, celecoxib, and acetaminophen for preventing pain after ambulatory otolaryngologic surgery. Anesth Analg. 2003 Apr;96(4):987-994. doi: 10.1213/01.ANE.0000053255.93270.31.

  PMID: 12651647 BACKGROUND

• Yenidunya O, Bircan HY, Altun D, Caymaz I, Demirag A, Turkoz A. Anesthesia management with ultrasound-guided thoracic paravertebral block for donor nephrectomy: A prospective randomized study. J Clin Anesth. 2017 Feb;37:1-6. doi: 10.1016/j.jclinane.2016.10.038. Epub 2016 Dec 15.

  PMID: 28235492 BACKGROUND

• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

  PMID: 27501016 BACKGROUND

• Forero M, Rajarathinam M, Adhikary S, Chin KJ. Continuous Erector Spinae Plane Block for Rescue Analgesia in Thoracotomy After Epidural Failure: A Case Report. A A Case Rep. 2017 May 15;8(10):254-256. doi: 10.1213/XAA.0000000000000478.

  PMID: 28252539 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

• Gordon DB, Polomano RC, Pellino TA, Turk DC, McCracken LM, Sherwood G, Paice JA, Wallace MS, Strassels SA, Farrar JT. Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) for quality improvement of pain management in hospitalized adults: preliminary psychometric evaluation. J Pain. 2010 Nov;11(11):1172-86. doi: 10.1016/j.jpain.2010.02.012. Epub 2010 Apr 18.

  PMID: 20400379 BACKGROUND

MeSH Terms

Conditions

Agnosia; Surgical Wound; Flank Pain

Interventions

Ropivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Pain

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed due Covid-19 and changes to surgical practice standard of care.

Results Point of Contact

• Title: Urology Research Operations Manager
• Organization: Milton S. Hershey Medical Center

UrologyResearch@pennstatehealth.psu.edu

717-531-0003

Study Officials

• Alireza Aminsharifi, M.D.

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

• Sanjib Adhikary, M.D.

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: October 2, 2018
• Study Start: September 28, 2018
• Primary Completion: January 19, 2024
• Study Completion: February 2, 2024
• Last Updated: February 10, 2025
• Results First Posted: February 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)