Randomized Controlled Comparison of Pre-op TLIP vs Intra-op TLIP

Withdrawn before enrolling · Not applicable

Conditions studied: Pain, Spine Fusion

In brief

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 fusion procedure will be scheduled and also consented as a part of the study. Participants will be stratified based on age and gender to ensure equal distribution.

Key facts

Study ID

NCT06154980

Run by

Corewell Health East

People needed

0

Starts

2024-10-28

Expected to finish

2025-10-21

Last updated by the study team

2025-10-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• William Beaumont Hospital — Royal Oak, Michigan, United States

Full record on ClinicalTrials.gov

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