Analgesic Requirement for Post-Operative Pain Control in Elective 1-3 Level Transforaminal Lumbar Interbody Fusion: Comparison of Thoracolumbar Interfascial Plane Block With Exparel to Bupivacaine HCl
Overview
- Phase
- Phase 2
- Intervention
- Exparel
- Conditions
- Back Pain
- Sponsor
- Foundation for Orthopaedic Research and Education
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Compare efficacy of thoracolumbar interfacial plane block with Exparel vs. standard of care (0.25% Bupivacaine HCL) is surgical subjects undergoing 1-3 level elective transforaminal lumbar interbody fusion.
- Status
- Enrolling by Invitation
- Last Updated
- last year
Overview
Brief Summary
The goal of this clinical trail is to to compare the efficacy of thoracolumbar interfascial plane block with Exparel vs with standard of care 0.25% Bupivacaine HCl in patients undergoing 1-3 level elective transforaminal lumbar interbody fusion. The investigators hypothesize that thoracolumbar interfascial plane block with Exparel will outperform standard of care (supplemented with interfascial plane block of 0.25% Bupivacaine HCl) with regards to pain reduction, narcotic use, length of hospital stay, time to mobilization with physical therapy, narcotic usage in the hospital, and post operative pain scores.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients 18 years or older,
- •Patients admitted to AHC for 1-3 level TLIF,
- •Patients who have given written informed consent,
- •BMI between 18-35 kg/m2,
Exclusion Criteria
- •Patients with known allergic reactions to standard of care analgesics,
- •Female patients who are pregnant
- •Patients with any previous lumbar spine instrumented surgery,
- •Chronic opioid use within 30 days prior to randomization that exceeds average ≥30 oral morphine equivalents/day,
- •Patients with known allergy to local anesthetics,
- •Patients with known or suspected to have neuromuscular disorders impairing neuromuscular blockade (e.g. myasthenia gravis).
Arms & Interventions
Exparel TLIP Injection
Subjects will receive 20 mL of EXPAREL 266mg mixed with 10 mL of 0.25% bupivacaine. A total of 30 mL of mixed solution is injected into the thoracolumbar interfacial plane.
Intervention: Exparel
Bupivicaine HCL TLIP Injection
Standard of care will consist of 0.25% Bupivacaine HCl TLIP injection. Subjects will receive 30 mL of the solution, injected into the thoracolumbar interfacial plane.
Intervention: Bupivacain
Outcomes
Primary Outcomes
Compare efficacy of thoracolumbar interfacial plane block with Exparel vs. standard of care (0.25% Bupivacaine HCL) is surgical subjects undergoing 1-3 level elective transforaminal lumbar interbody fusion.
Time Frame: 0-72 hours post-operatively
Data will be analyzed by randomized treatment group to determine efficacy. Superiority of treatment with EXPAREL compared with Bupivacaine hydrochloride will be determined using linear regression adjusting for Pain Catastrophizing Scale with treatment as main effect for the primary efficacy endpoint of area under the curve of the Numerical rating scale pain intensity scores from 0 to 72 hours post-surgery.
Secondary Outcomes
- Total Postsurgical opioid consumption(0-72 hours postoperatively)
- Time to discharge(0-72 hours postoperatively)
- Time to ambulation(0-72 hours postoperatively)
- Maximum ambulated distance(0-72 hours postoperatively)
- Numeric Rating Pain Scale (Physical Therapy)(0-72 hours postoperatively)
- Numeric Rating Pain Scale(0-72 hours with additional follow-up at 14 days (first clinic visit))
- Oswestry Disability Index (ODI)(0- 14 days postoperatively)
- Pain Catastrophizing Scale (PCS)(0-14 days postoperatively)