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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE2/PHASE3

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-30

Study Completion Date

2026-03-01

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

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Exparel TLIP Injection

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.

Group Type EXPERIMENTAL

Exparel

Intervention Type DRUG

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

Bupivicaine HCL TLIP Injection

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.

Group Type ACTIVE_COMPARATOR

Bupivacain

Intervention Type DRUG

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

Interventions

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Exparel

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

Intervention Type DRUG

Bupivacain

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

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No