Back Pain, Narcotic Use, Physical Stress, Post Operative Pain, Surgery-Complications
Conditions
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.
Interventions
DRUGExparel
20 mL of EXPAREL 266mg mixed with 10 mL of 0.25% bupivacaine
DRUGBupivacain
Standard of care will consist of 0.25% Bupivacaine HCl TLIP injection 30mL
Sponsors
Foundation for Orthopaedic Research and Education
Pacira Pharmaceuticals, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Study subjects will be randomized to either Group 1 or Group 2 in a 1:1 ratio based on the randomization scheme in sealed envelopes maintained by the study coordinator.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| 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) |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJohn Small, MD
Florida Orthopaedic Institute
Outcome results
None listed