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

NCT06350981 | Enrolling By Invitation Phase 2 DMC FDA Drug

• 1 other identifier: FORE813
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  0-72 hours post-operatively

Secondary Outcomes (8)

• 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

Study Arms (2)

Exparel TLIP Injection

EXPERIMENTAL

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.

Drug: Exparel

Bupivicaine HCL TLIP Injection

ACTIVE COMPARATOR

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.

Drug: Bupivacain

Interventions

Exparel DRUG

20 mL of EXPAREL 266mg mixed with 10 mL of 0.25% bupivacaine

Exparel TLIP Injection

Bupivacain DRUG

Standard of care will consist of 0.25% Bupivacaine HCl TLIP injection 30mL

Bupivicaine HCL TLIP Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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).

Sponsors & Collaborators

• Foundation for Orthopaedic Research and Education: lead
• Pacira Pharmaceuticals, Inc: collaborator

Study Sites (1)

Foundation for Orthopaedic Research and Education

Tampa, Florida, 33607, United States

Location

MeSH Terms

Conditions

Back Pain; Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• John Small, MD

  Florida Orthopaedic Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: April 8, 2024
• Study Start: April 30, 2024
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)