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Enrolling by Invitation

NCT Number: NCT06350981

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

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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Key information

Conditions

Back Pain Narcotic Use Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Physical Stress Post Operative Pain Postoperative Complications Signs and Symptoms Surgery-Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Foundation for Orthopaedic Research and Education

Tampa, Florida, 33607, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Exparel

Drug

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

Bupivacain

Drug

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

Primary outcomes

  1. 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.

    Time frame: 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 outcomes

  1. Total Postsurgical opioid consumption

    Time frame: 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

  2. Time to discharge

    Time frame: 0-72 hours postoperatively

    collect hours of hospital stay

  3. Time to ambulation

    Time frame: 0-72 hours postoperatively

    collect time ambulated from surgery

  4. Maximum ambulated distance

    Time frame: 0-72 hours postoperatively

    Physical Therapy will document the distance subject could ambulate after surgery

  5. Numeric Rating Pain Scale (Physical Therapy)

    Time frame: 0-72 hours postoperatively

    Measure pain score (scale of 0-10 with 0 indicates no pain and 10 severe pain) during physical therapy (ambulation)

  6. Numeric Rating Pain Scale

    Time frame: 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)

  7. Oswestry Disability Index (ODI)

    Time frame: 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.

  8. Pain Catastrophizing Scale (PCS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Foundation for Orthopaedic Research and Education

Other

Collaborators

  • Pacira Pharmaceuticals, Inc

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2024
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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