Clinical trial

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

Name
FORE813
Description
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.
Trial arms
Trial start
2024-04-01
Estimated PCD
2025-01-01
Trial end
2025-03-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Exparel
20 mL of EXPAREL 266mg mixed with 10 mL of 0.25% bupivacaine
Arms:
Exparel TLIP Injection
Bupivacain
Standard of care will consist of 0.25% Bupivacaine HCl TLIP injection 30mL
Arms:
Bupivicaine HCL TLIP Injection
Size
76
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.
0-72 hours post-operatively
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).
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Study subjects will be randomized to either Group 1 or Group 2 in a 1:1 ratio based on the randomization scheme in sealed envelopes maintained by the study coordinator.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 76, 'type': 'ESTIMATED'}}
Updated at
2024-04-08

1 organization

2 products

5 indications

Product
Exparel
Indication
Back Pain
Indication
Drug Use
Indication
Physical Stress
Product
Bupivacain