Randomized, Placebo-controlled Trial of Erector Spinae Plane Blocks (ESPB) for Perioperative Pain Management for Minimally Invasive (MIS) Lumbar Spine Surgery
Overview
- Phase
- Phase 4
- Intervention
- normal saline
- Conditions
- Lumbar Spinal Stenosis
- Sponsor
- John O'Toole
- Enrollment
- 125
- Locations
- 1
- Primary Endpoint
- Inpatient opioid consumption
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
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.
Investigators
John O'Toole
Professor of Neurosurgery
Rush University Medical Center
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
Arms & Interventions
Control
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: normal saline
Investigational
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.
Intervention: Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine
Outcomes
Primary Outcomes
Inpatient opioid consumption
Time Frame: Every 1 day during inpatient admission up to 30 days
Mean per day inpatient opioid consumption in morphine milligram equivalents (MME)
Secondary Outcomes
- 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, up to 90 days)
- Postoperative pain scores(Every 1 day during inpatient admission up to 30 days)
- Peri-operative complications(Time of surgery to 6 weeks postoperative)
- Patient-reported pain and functional outcomes(From baseline preoperative values to 6 week post-operative values)
- Post-operative delirium(Immediately post-surgery to discharge)