Status:
WITHDRAWN
Randomized Controlled Comparison of Pre-op TLIP vs Intra-op TLIP
Lead Sponsor:
Corewell Health East
Conditions:
Pain
Spine Fusion
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Single-center, randomized study will enroll 50 subjects who are scheduled for 1-3 level posterior laminectomy \& fusion. Study participants who are eligible for the posterior lumbar laminectomy and fu...
Detailed Description
This is a single-center, randomized study. The study will enroll 50 subjects who are scheduled for 1-3 level posterior laminectomy \& fusion. Potential participants who are eligible for the posterior ...
Eligibility Criteria
Inclusion
- greater than or equal to 18 years of age on the date of service
- require a 1 to 3 level posterior laminectomy with fusion
- compliant with study requirements and outpatient follow-up
- a daily MME less than 25 MME per day in the per-operative period
Exclusion
- younger than 18 years of age on the date of service
- does not consent to participating in the program or to be refusal to follow-up at 2-3 weeks, 4-6 weeks, and 3 months post-operatively
- requiring revision surgery at the same level for posterior laminectomy with fusion
- a daily MME score \>25 MME/day in the pre-operative period will be excluded
- a positive drug screen for cocaine and/or tetrahydrocannabinol (THC), defined in the standard Corewell Drugs of Abuse Screening as cocaine \> 300 ng/mL and cannabinoid \> 50 ng/mL-any
- ongoing lawsuits, workers compensation, and litigation will be excluded.
Key Trial Info
Start Date :
October 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 21 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06154980
Start Date
October 28 2024
End Date
October 21 2025
Last Update
October 23 2025
Active Locations (1)
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1
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073