NCT06350981

Analgesic Requirement for Post-Operative Pain Control in TLIP Interbody Fusion

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

• Status: Enrolling By Invitation
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Foundation for Orthopaedic Research and Education · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Back Pain
• Surgery-Complications
• Narcotic Use
• Physical Stress
• Post Operative Pain

Interventions

Type	Name	Description
DRUG	Exparel	20 mL of EXPAREL 266mg mixed with 10 mL of 0.25% bupivacaine
DRUG	Bupivacain	Standard of care will consist of 0.25% Bupivacaine HCl TLIP injection 30mL

Timeline

• Start date: 2024-04-30
• Primary completion: 2026-01-01
• Completion: 2026-03-01
• First posted: 2024-04-08
• Last updated: 2025-02-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study