Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

NCT05029726 | Recruiting Phase 4 FDA Drug

• 1 other identifier: ORA20050502
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

Opioid overuse is a widespread public health crisis in the United States with increasing rates of addiction and overdose deaths from prescription opioids. Reducing the need for opiate analgesics in the post-operative setting has become a high priority in minimizing long-term opioid use in surgical patients. This study will serve to demonstrate the efficacy of the addition of regional analgesic techniques in reducing post-operative opioid requirements in patients undergoing common lumbar spinal surgical procedures.

Conditions

Lumbar Disc Herniation; Lumbar Spondylolisthesis; Lumbar Spondylosis; Lumbar Radiculopathy; Lumbar Spine Instability; Synovial Cyst; Degenerative Disc Disease; Degenerative Spondylolisthesis; Degenerative Intervertebral Discs; Lumbar Spinal Stenosis

Keywords

erector spinae plane block; minimally invasive spine surgery; regional anesthesia; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Inpatient opioid consumption

  Mean per day inpatient opioid consumption in morphine milligram equivalents (MME)

  Every 1 day during inpatient admission up to 30 days

Secondary Outcomes (11)

• Post-discharge opioid consumption

  14 days (+/- 7days) ,56 days (+/- 14 days) and 90 days (+/- 19) postoperatively

• Postoperative opioid prescriptions filled

  From hospital discharge to 90 days postoperatively

• Length of hospital stay

  From time of surgery to time discharge criteria met in hours, up to 2160 hours

• Postoperative Urinary Retention (POUR)

  Immediately post-surgery to discharge, up to 90 days

• Post-operative delirium

  Immediately post-surgery to discharge

Study Arms (2)

Investigational

EXPERIMENTAL

Patients will undergo regional ESPB with bupivacaine plus clonidine in the holding area of the OR immediately prior to surgery. 30mL of 0.25% bupivacaine/1:200,000 epinephrine/50mcg clonidine will be administered bilaterally (total 60ml) to the lumbar paraspinal erector spine plane using ultrasound-guidance.

Drug: Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine

Control

PLACEBO COMPARATOR

Patients will receive a placebo injection of normal saline via the same ESPB technique. 30ml of normal saline will be administered bilaterally (total 60ml) to the lumbar paraspinal erector spine plane using ultrasound-guidance.

Drug: normal saline

Interventions

Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine DRUG

Bupivacaine-Epinephrine 0.25%-1:200,000 plus clonidine 50 micrograms in 30cc syringes administered as ESPB

Investigational

normal saline DRUG

normal saline in 30cc syringes administered using ESPB technique

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80
• Undergoing one of 3 procedure types: 1) 2 or more levels of MIS decompression (e.g., discectomy, foraminotomy, laminectomy); 2) 1-3 levels of MIS transforaminal lumbar interbody fusion (TLIF) (with or without additional levels of MIS decompression for no greater than 3 total operative levels); 3) 1-3 levels of anterior lumbar interbody fusion (ALIF) or MIS lateral lumbar interbody fusion (LLIF) accompanied by posterior percutaneous instrumentation at the same levels
• Willing and able to give consent

You may not qualify if:

• Opioid tolerant at the time of the surgical procedure--defined as consuming greater than 30mg of morphine milligram equivalents (MME) daily (https://www.cdc.gov/drugoverdose/prescribing/guideline.html)
• Presence of an indwelling pain device (e.g., intrathecal opioid pump, spinal cord stimulator, dorsal root ganglion stimulator)
• Known allergy to bupivacaine, clonidine or similar local anesthetics
• Indication for surgery other than degenerative disease (e.g., neoplasm, infection, trauma)
• Chronic kidney disease (stage 3 or greater), or hepatic failure
• Active pregnancy
• Disease process or mental illness that would preclude accurate evaluation of pain in the perioperative period
• Active Worker's Compensation litigation

Sponsors & Collaborators

• John O'Toole: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Related Publications (9)

• 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

• Chin KJ, Dinsmore MJ, Lewis S, Chan V. Opioid-sparing multimodal analgesia with bilateral bi-level erector spinae plane blocks in scoliosis surgery: a case report of two patients. Eur Spine J. 2020 Dec;29(Suppl 2):138-144. doi: 10.1007/s00586-019-06133-8. Epub 2019 Sep 3.

  PMID: 31482311 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

• 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

• 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

• 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

• van den Broek RJC, van de Geer R, Schepel NC, Liu WY, Bouwman RA, Versyck B. Evaluation of adding the Erector spinae plane block to standard anesthetic care in patients undergoing posterior lumbar interbody fusion surgery. Sci Rep. 2021 Apr 7;11(1):7631. doi: 10.1038/s41598-021-87374-w.

  PMID: 33828209 BACKGROUND

• Armaghani SJ, Lee DS, Bible JE, Archer KR, Shau DN, Kay H, Zhang C, McGirt MJ, Devin CJ. Preoperative opioid use and its association with perioperative opioid demand and postoperative opioid independence in patients undergoing spine surgery. Spine (Phila Pa 1976). 2014 Dec 1;39(25):E1524-30. doi: 10.1097/BRS.0000000000000622.

  PMID: 25417827 BACKGROUND

• Kalakoti P, Hendrickson NR, Bedard NA, Pugely AJ. Opioid Utilization Following Lumbar Arthrodesis: Trends and Factors Associated With Long-term Use. Spine (Phila Pa 1976). 2018 Sep 1;43(17):1208-1216. doi: 10.1097/BRS.0000000000002734.

  PMID: 30045343 BACKGROUND

MeSH Terms

Conditions

Spinal Stenosis; Intervertebral Disc Displacement; Spondylolisthesis; Spondylosis; Radiculopathy; Synovial Cyst; Intervertebral Disc Degeneration

Interventions

Clonidine; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• John O'Toole, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bart Jacher

CONTACT

(888) 352-7874; bartosz_jacher@rush.edu

Morgan Mulcahy

CONTACT

(888) 352-7874; morgan_l_mulcahy@rush.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients, surgeons and anesthesiologists will all be blinded to treatment allocation. Syringes containing the fluid to be injected will be prepared by pharmacy and labeled with subject number in such a manner to blind the anesthesiologist performing the ESPB to its contents.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Neurosurgery

Model Details: All patients will undergo surgery using an enhanced recovery after surgery (ERAS) multi-modal anesthesia protocol that is currently in standard use for MIS lumbar spine surgical procedures. Patients will be randomized in a 1:1 ratio to investigational and control arms.

Study Record Dates

• First Submitted: August 14, 2021
• First Posted: August 31, 2021
• Study Start: February 1, 2022
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)