Analgesic Requirement for Post-Operative Pain Control in TLIP Interbody Fusion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exparel, Bupivacain.
- Who it may be relevant to
- Registry conditions: Back Pain, Surgery-Complications, Narcotic Use, Physical Stress. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug Exparel
20 mL of EXPAREL 266mg mixed with 10 mL of 0.25% bupivacaine - Drug Bupivacain
Standard of care will consist of 0.25% Bupivacaine HCl TLIP injection 30mL
Primary outcome measures
- 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]
Secondary outcome measures (8)
- Total Postsurgical opioid consumption [Time frame: 0-72 hours postoperatively]
- Time to discharge [Time frame: 0-72 hours postoperatively]
- Time to ambulation [Time frame: 0-72 hours postoperatively]
- Maximum ambulated distance [Time frame: 0-72 hours postoperatively]
- Numeric Rating Pain Scale (Physical Therapy) [Time frame: 0-72 hours postoperatively]
- Numeric Rating Pain Scale [Time frame: 0-72 hours with additional follow-up at 14 days (first clinic visit)]
- Oswestry Disability Index (ODI) [Time frame: 0- 14 days postoperatively]
- Pain Catastrophizing Scale (PCS) [Time frame: 0-14 days postoperatively]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Foundation for Orthopaedic Research and Education — Tampa
Identifiers
NCT: NCT06350981 · FORE813