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

Phase 2

• Conditions: Surgery-Complications; Post Operative Pain; Narcotic Use; Back Pain; Physical Stress
• Interventions: Drug: Exparel; Drug: Bupivacain

• Registration Number: NCT06350981
• Lead Sponsor: Foundation for Orthopaedic Research and Education

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-15
• Study First Submitted QC: 2024-04-03
• Study First Posted: 2024-04-08
• Study Start: 2024-04-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-25
• Primary Completion: 2026-01-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exparel TLIP Injection	Exparel	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.
Bupivicaine HCL TLIP Injection	Bupivacain	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.

Primary Outcome Measures

Name	Time	Method
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.	0-72 hours post-operatively	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.

Secondary Outcome Measures

Name	Time	Method
Total Postsurgical opioid consumption	0-72 hours postoperatively	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
Time to discharge	0-72 hours postoperatively	collect hours of hospital stay
Numeric Rating Pain Scale	0-72 hours with additional follow-up at 14 days (first clinic visit)	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)
Time to ambulation	0-72 hours postoperatively	collect time ambulated from surgery
Maximum ambulated distance	0-72 hours postoperatively	Physical Therapy will document the distance subject could ambulate after surgery
Numeric Rating Pain Scale (Physical Therapy)	0-72 hours postoperatively	Measure pain score (scale of 0-10 with 0 indicates no pain and 10 severe pain) during physical therapy (ambulation)
Oswestry Disability Index (ODI)	0- 14 days postoperatively	10 questions relating to function specific to low back pain given before surgery and collected at 14 day post op visit.
Pain Catastrophizing Scale (PCS)	0-14 days postoperatively	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.

Trial Locations

Locations (1)

Foundation for Orthopaedic Research and Education; 🇺🇸 Tampa, Florida, United States