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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06350981
Other study ID # FORE813
Secondary ID
Status Enrolling by invitation
Phase Phase 2/Phase 3
First received
Last updated
Start date April 30, 2024
Est. completion date March 1, 2025

Study information

Verified date June 2024
Source Foundation for Orthopaedic Research and Education
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 76
Est. completion date March 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Drug:
Exparel
20 mL of EXPAREL 266mg mixed with 10 mL of 0.25% bupivacaine
Bupivacain
Standard of care will consist of 0.25% Bupivacaine HCl TLIP injection 30mL

Locations

Country Name City State
United States Foundation for Orthopaedic Research and Education Tampa Florida

Sponsors (2)

Lead Sponsor Collaborator
Foundation for Orthopaedic Research and Education Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Time to discharge collect hours of hospital stay 0-72 hours postoperatively
Secondary Time to ambulation collect time ambulated from surgery 0-72 hours postoperatively
Secondary Maximum ambulated distance Physical Therapy will document the distance subject could ambulate after surgery 0-72 hours postoperatively
Secondary 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
Secondary 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)
Secondary 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
Secondary 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
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