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

Foundation for Orthopaedic Research and Education

Status and phase: Invitation-only; Phase 3; Phase 2

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

Treatments: Drug: Exparel; Drug: Bupivacain

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06350981

FORE813

Details and patient eligibility

About

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.

Enrollment: 76 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 2 patient groups

Exparel TLIP Injection

Experimental group

Description:

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.

Treatment:

Drug: Exparel

Bupivicaine HCL TLIP Injection

Active Comparator group

Description:

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.

Treatment:

Drug: Bupivacain