search
Back to results

Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

Primary Purpose

Lumbar Spinal Stenosis, Lumbar Disc Herniation, Lumbar Spondylolisthesis

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine
normal saline
Sponsored by
John O'Toole
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spinal Stenosis focused on measuring erector spinae plane block, minimally invasive spine surgery, regional anesthesia, randomized controlled trial

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-75
  • 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

Sites / Locations

  • Rush University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Investigational

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Post-discharge opioid consumption
Total and per day mean postoperative opioid consumption after hospital discharge in MME as recorded in medication diary by patients
Postoperative opioid prescriptions filled
• Total MMEs of opioid prescriptions filled as found on the Illinois Prescription Monitoring Program website
Length of hospital stay
Duration of hospital stay postoperatively measured in days as determined by the time at which each patient met discharge criteria
Postoperative Urinary Retention (POUR)
Incidence of POUR measured as proportion of inpatient hospital days demonstrating the need for straight catheterization or foley placement
Post-operative delirium
Incidence of post-operative delirium as measured by the need for placement of physical restraints
Post-operative delirium
Incidence of post-operative delirium as measured by the administration of new anti-psychotic medications
Postoperative pain scores
Mean daily VAS (visual analog scale) pain scores recorded in the electronic medical record (EMR)
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)
Patient-reported pain and functional outcomes
Change in Oswestry Disability Index (ODI; 0 to 100 with 100 being worst)
Patient-reported pain and functional outcomes
Change in Short Form 12/6D (SF-12/6D; 0 to 100 with 0 being worst)
Peri-operative complications
Prospectively documented medical and surgical complications/adverse events (AEs) including rates of readmission or reoperation for AEs

Full Information

First Posted
August 14, 2021
Last Updated
February 18, 2023
Sponsor
John O'Toole
search

1. Study Identification

Unique Protocol Identification Number
NCT05029726
Brief Title
Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery
Official Title
Randomized, Placebo-controlled Trial of Erector Spinae Plane Blocks (ESPB) for Perioperative Pain Management for Minimally Invasive (MIS) Lumbar Spine Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
John O'Toole

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis, Lumbar Disc Herniation, Lumbar Spondylolisthesis, Lumbar Spondylosis, Lumbar Radiculopathy, Lumbar Spine Instability, Synovial Cyst, Degenerative Disc Disease, Degenerative Spondylolisthesis, Degenerative Intervertebral Discs
Keywords
erector spinae plane block, minimally invasive spine surgery, regional anesthesia, randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Investigational
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine
Intervention Description
Bupivacaine-Epinephrine 0.25%-1:200,000 plus clonidine 50 micrograms in 30cc syringes administered as ESPB
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
normal saline in 30cc syringes administered using ESPB technique
Primary Outcome Measure Information:
Title
Inpatient opioid consumption
Description
Mean per day inpatient opioid consumption in morphine milligram equivalents (MME)
Time Frame
Every 1 day during inpatient admission up to 30 days
Secondary Outcome Measure Information:
Title
Post-discharge opioid consumption
Description
Total and per day mean postoperative opioid consumption after hospital discharge in MME as recorded in medication diary by patients
Time Frame
14 days (+/- 7days) ,56 days (+/- 14 days) and 90 days (+/- 19) postoperatively
Title
Postoperative opioid prescriptions filled
Description
• Total MMEs of opioid prescriptions filled as found on the Illinois Prescription Monitoring Program website
Time Frame
From hospital discharge to 90 days postoperatively
Title
Length of hospital stay
Description
Duration of hospital stay postoperatively measured in days as determined by the time at which each patient met discharge criteria
Time Frame
From time of surgery to time discharge criteria met in hours, up to 2160 hours
Title
Postoperative Urinary Retention (POUR)
Description
Incidence of POUR measured as proportion of inpatient hospital days demonstrating the need for straight catheterization or foley placement
Time Frame
Immediately post-surgery to discharge, up to 90 days
Title
Post-operative delirium
Description
Incidence of post-operative delirium as measured by the need for placement of physical restraints
Time Frame
Immediately post-surgery to discharge
Title
Post-operative delirium
Description
Incidence of post-operative delirium as measured by the administration of new anti-psychotic medications
Time Frame
Immediately post-surgery to discharge, up to 90 days
Title
Postoperative pain scores
Description
Mean daily VAS (visual analog scale) pain scores recorded in the electronic medical record (EMR)
Time Frame
Every 1 day during inpatient admission up to 30 days
Title
Patient-reported pain and functional outcomes
Description
Change in Visual Analog Scale (VAS) for pain in the back and leg (0-10 with 10 being worst)
Time Frame
From baseline preoperative values to 6 week post-operative values
Title
Patient-reported pain and functional outcomes
Description
Change in Oswestry Disability Index (ODI; 0 to 100 with 100 being worst)
Time Frame
From baseline preoperative values to 6 week post-operative values
Title
Patient-reported pain and functional outcomes
Description
Change in Short Form 12/6D (SF-12/6D; 0 to 100 with 0 being worst)
Time Frame
From baseline preoperative values to 6 week post-operative values
Title
Peri-operative complications
Description
Prospectively documented medical and surgical complications/adverse events (AEs) including rates of readmission or reoperation for AEs
Time Frame
Time of surgery to 6 weeks postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bart Jacher
Phone
(888) 352-7874
Email
bartosz_jacher@rush.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Morgan Mulcahy
Phone
(888) 352-7874
Email
morgan_l_mulcahy@rush.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John O'Toole, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bart Jacher
Phone
888-352-7874
Email
bartosz_jacher@rush.edu
First Name & Middle Initial & Last Name & Degree
Morgan Mulcahy
Phone
(888) 352-7874
Email
morgan_l_mulcahy@rush.edu
First Name & Middle Initial & Last Name & Degree
John O'Toole, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30180150
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.
Results Reference
background
PubMed Identifier
31482311
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.
Results Reference
background
PubMed Identifier
27501016
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.
Results Reference
background
PubMed Identifier
29704223
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.
Results Reference
background
PubMed Identifier
31033625
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.
Results Reference
background
PubMed Identifier
30424594
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.
Results Reference
background
PubMed Identifier
33828209
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.
Results Reference
background
PubMed Identifier
25417827
Citation
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.
Results Reference
background
PubMed Identifier
30045343
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.
Results Reference
background

Learn more about this trial

Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

We'll reach out to this number within 24 hrs