drugset / Trial / NCT06350981
Analgesic Requirement for Post-Operative Pain Control in TLIP Interbody Fusion
Phase 2/3
Enrolling by invitation
76 enrolled
Foundation for Orthopaedic Research and Education
Pacira Pharmaceuticals, Inc · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2024-04-30
- Primary completion
- 2026-01-01
- Completion
- 2026-03-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bupivacaine | Other / unclassified | 0.25 % | Other |
| Comparator | Bupivacaine | Other / unclassified | 10 ml | Other |
| Comparator | Bupivacaine | Other / unclassified | 30 ml | Other |
| Comparator | Bupivacaine | Other / unclassified | 266 mg | Other |