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

NCT06350981 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2025-02-25

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Pacira Pharmaceuticals, Inc

    collaborator INDUSTRY

  • Foundation for Orthopaedic Research and Education

    lead OTHER

Principal Investigators

  • John Small, MD · Florida Orthopaedic Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-30
Primary Completion
2026-01-01
Completion
2026-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06350981 on ClinicalTrials.gov