Clinical trial NCT06350981: Analgesic Requirement for Post-Operative Pain Control in TLIP Interbody Fusion
Official title: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
PHASE3
Conditions: Back Pain
Surgery-Complications
Narcotic Use
Physical Stress
Post Operative Pain
Lead sponsor: Foundation for Orthopaedic Research and Education
Sponsor class: OTHER
Collaborators: name: Pacira Pharmaceuticals, Inc
First posted: 2024-04-08
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: 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.
timeFrame: 0-72 hours post-operatively
Secondary outcomes:
measure: Total Postsurgical opioid consumption
timeFrame: 0-72 hours postoperatively
measure: Time to discharge
timeFrame: 0-72 hours postoperatively
measure: Time to ambulation
timeFrame: 0-72 hours postoperatively
measure: Maximum ambulated distance
timeFrame: 0-72 hours postoperatively
measure: Numeric Rating Pain Scale (Physical Therapy)
timeFrame: 0-72 hours postoperatively
measure: Numeric Rating Pain Scale
timeFrame: 0-72 hours with additional follow-up at 14 days (first clinic visit)
measure: Oswestry Disability Index (ODI)
timeFrame: 0- 14 days postoperatively
measure: Pain Catastrophizing Scale (PCS)
timeFrame: 0-14 days postoperatively
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Foundation for Orthopaedic Research and Education
state: Florida
Study officials:
affiliation: Florida Orthopaedic Institute
name: John Small, MD
role: PRINCIPAL_INVESTIGATOR
References: