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

Analgesic Requirement for Post-Operative Pain Control in Elective 1-3 Level Transforaminal Lumbar Interbody Fusion: Comparison of Thoracolumbar Interfascial Plane Block With Exparel to Bupivacaine HCl

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 Overview

• Status: Enrolling by invitation
• Conditions: Back Pain; Post Operative Pain; Physical Stress; Narcotic Use; Surgery-Complications
• Intervention / Treatment: Drug: Exparel; Drug: Bupivacain

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33607
      • Foundation for Orthopaedic Research and Education

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Exparel; 20 mL of EXPAREL 266mg mixed with 10 mL of 0.25% bupivacaine
Active Comparator: 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.	Drug: Bupivacain; Standard of care will consist of 0.25% Bupivacaine HCl TLIP injection 30mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	0-72 hours postoperatively
Time to discharge	collect hours of hospital stay	0-72 hours postoperatively
Time to ambulation	collect time ambulated from surgery	0-72 hours postoperatively
Maximum ambulated distance	Physical Therapy will document the distance subject could ambulate after surgery	0-72 hours postoperatively
Numeric Rating Pain Scale (Physical Therapy)	Measure pain score (scale of 0-10 with 0 indicates no pain and 10 severe pain) during physical therapy (ambulation)	0-72 hours postoperatively
Numeric Rating Pain Scale	Numerical rating scale pain intensity scores at 24hour, 36hour, 60hour, and 72hour from the end of surgery and again at the first clinic visit postoperatively (scale of 0-10 with 0 indicates no pain and 10 severe pain)	0-72 hours with additional follow-up at 14 days (first clinic visit)
Oswestry Disability Index (ODI)	10 questions relating to function specific to low back pain given before surgery and collected at 14 day post op visit.	0- 14 days postoperatively
Pain Catastrophizing Scale (PCS)	This scale measures thoughts and feelings that may be associated with pain. it is rated 0-5 with 0 indicating not at all, 1 indicating to a slight degree, 2 indicates a moderate degree, 3 indicates a great degree and 4 idicates all the time. There are 13 statements that are rated, the ratings are scored to determine where each subject falls in the scale.	0-14 days postoperatively

Collaborators and Investigators

• Sponsor: Foundation for Orthopaedic Research and Education
• Collaborators: Pacira Pharmaceuticals, Inc
• Investigators: Principal Investigator: John Small, MD, Florida Orthopaedic Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: March 15, 2024
• First Submitted That Met QC Criteria: April 3, 2024
• First Posted (Actual): April 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 24, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Bupivacaine
• Other Study ID Numbers: FORE813

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No