Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

Degenerative Disc Disease Clinical Trial

Official title:

Randomized, Placebo-controlled Trial of Erector Spinae Plane Blocks (ESPB) for Perioperative Pain Management for Minimally Invasive (MIS) Lumbar Spine Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05029726
• Other study ID #: ORA20050502
• Status: Recruiting
• Phase: Phase 4
• Start date: February 1, 2022
• Est. completion date: April 30, 2025

Study information

• Verified date: January 2024
• Source: Rush University Medical Center
• Contact: Bart Jacher
• Phone: (888) 352-7874
• Email: bartosz_jacher[@]rush.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Opioid abuse and misuse remain a public health crisis in the United States, notably in patients with chronic pain from degenerative spine disease. Perioperative pain management for patients undergoing spinal surgery remains largely reliant on opioid medications, with several known adverse effects including, but not limited to delirium, postoperative urinary retention (POUR), constipation and nausea. These side effects contribute to increased hospital length of stay (LOS) with increased incidence of overall in-hospital complications, perioperative costs, and increased rates of opioid habituation and addiction.

Dependence on prescription opioids has been associated with wide-ranging social and economic consequences including increased opioid overdose resulting in death, growing opioid-related incarcerations, and spiraling opioid-related healthcare cost from treatment of addiction, opioid-related mental health issues, and debilitating chronic pain. Long-term requirements for opioid medications may be associated with the use of higher doses of opioids in the perioperative period for patients undergoing invasive surgery for spinal degenerative conditions. Studies have demonstrated that patients who consume fewer opioids for 30 days after surgery are less likely to progress to become chronic opioid users. Regional analgesic techniques have shown promise in decreasing post-operative pain and opioid requirements in thoracic and abdominal surgery but difficulties with post-operative neurological assessments have limited their use in spinal surgery. Inter-fascial plane blocks, however, have emerged as a safe and potentially useful regional analgesic technique to mitigate the pain-inducing effects of posterior spine surgery.

Erector Spinae Plane Blocks (ESPBs), specifically, involve ultra-sound guided injection of local anesthetic (LA) posteriorly beneath the erector spinae muscles resulting in longitudinal and ventrolateral spread of the anesthetic into the paravertebral space where the ventral and dorsal rami of the spinal nerves are located thereby inducing a multi-level analgesic effect. Depending upon the LA used, this effect may last for 4 to 36 hours.

The proposed study will examine the efficacy of preoperative ESPBs in reducing post-operative opioid utilization and its associated complications specifically after minimally invasive (MIS) lumbar spine surgery including both decompressive and instrumented fusion procedures. The guiding principle of MIS spine surgery is reduction of iatrogenic injury by utilizing muscle dilating approaches and tubular retractors rather than conventional open, subperiosteal muscle stripping techniques. The latter typically results in muscle denervation and devascularization as well as postoperative muscle atrophy and dead space creation that increase postoperative pain, muscle dysfunction, prolonged recovery times and complications. Since MIS spinal surgical procedures preserve normal paraspinal musculature compared to open surgery, the magnitude of effect of ESPBs may actually be more pronounced in this population.

The investigators hypothesize that by conducting this investigation within the rigor of a double-blinded, randomized placebo-controlled clinical trial, the results will definitively demonstrate that the addition of regional analgesia in the form of ESPB during MIS lumbar spine surgery will 1) reduce post-operative opioid consumption and 2) reduce opioid-related complications and hospital LOS but 3) have no adverse effects on postoperative pain control.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: April 30, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Degenerative Intervertebral Discs
• Degenerative Spondylolisthesis
• Intervertebral Disc Degeneration
• Intervertebral Disc Displacement
• Lumbar Disc Herniation
• Lumbar Radiculopathy
• Lumbar Spinal Stenosis
• Lumbar Spine Instability
• Lumbar Spondylolisthesis
• Lumbar Spondylosis
• Radiculopathy
• Spinal Stenosis
• Spondylolisthesis
• Spondylosis

Intervention

Drug:
• Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine
Bupivacaine-Epinephrine 0.25%-1:200,000 plus clonidine 50 micrograms in 30cc syringes administered as ESPB
• normal saline
normal saline in 30cc syringes administered using ESPB technique

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
John O'Toole

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Post-discharge opioid consumption	Total and per day mean postoperative opioid consumption after hospital discharge in MME as recorded in medication diary by patients	14 days (+/- 7days) ,56 days (+/- 14 days) and 90 days (+/- 19) postoperatively
Secondary	Postoperative opioid prescriptions filled	• Total MMEs of opioid prescriptions filled as found on the Illinois Prescription Monitoring Program website	From hospital discharge to 90 days postoperatively
Secondary	Length of hospital stay	Duration of hospital stay postoperatively measured in days as determined by the time at which each patient met discharge criteria	From time of surgery to time discharge criteria met in hours, up to 2160 hours
Secondary	Postoperative Urinary Retention (POUR)	Incidence of POUR measured as proportion of inpatient hospital days demonstrating the need for straight catheterization or foley placement	Immediately post-surgery to discharge, up to 90 days
Secondary	Post-operative delirium	Incidence of post-operative delirium as measured by the need for placement of physical restraints	Immediately post-surgery to discharge
Secondary	Post-operative delirium	Incidence of post-operative delirium as measured by the administration of new anti-psychotic medications	Immediately post-surgery to discharge, up to 90 days
Secondary	Postoperative pain scores	Mean daily VAS (visual analog scale) pain scores recorded in the electronic medical record (EMR)	Every 1 day during inpatient admission up to 30 days
Secondary	Patient-reported pain and functional outcomes	Change in Visual Analog Scale (VAS) for pain in the back and leg (0-10 with 10 being worst)	From baseline preoperative values to 6 week post-operative values
Secondary	Patient-reported pain and functional outcomes	Change in Oswestry Disability Index (ODI; 0 to 100 with 100 being worst)	From baseline preoperative values to 6 week post-operative values
Secondary	Patient-reported pain and functional outcomes	Change in Short Form 12/6D (SF-12/6D; 0 to 100 with 0 being worst)	From baseline preoperative values to 6 week post-operative values
Secondary	Peri-operative complications	Prospectively documented medical and surgical complications/adverse events (AEs) including rates of readmission or reoperation for AEs	Time of surgery to 6 weeks postoperative