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

Phase 3Enrolling By InvitationNCT06350981

Foundation for Orthopaedic Research and Education76 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

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

Interventions

ExparelDRUG

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

BupivacainDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Foundation for Orthopaedic Research and Education

Tampa, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: 0-72 hours post-operatively

Secondary Outcomes

Total Postsurgical opioid consumption

The following data points will be recorded to further claim the investigators hypothesis of treatment with EXPAREL compared to Bupivacaine hydrochloride. • Total postsurgical opioid consumption in oral morphine equivalents (Oral morphine equivalents) from 0 to 76 hours post-surgery