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

Launched by WILLIAM BEAUMONT HOSPITALS · Dec 1, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two different timing methods for administering a treatment called TLIP (which helps with pain management) for patients undergoing spine surgery, specifically a procedure known as posterior laminectomy with fusion. Researchers want to find out if giving TLIP before the surgery (pre-op) is more effective than giving it during the surgery (intra-op) in managing pain after the procedure. The study aims to enroll 50 participants aged 18 and older who need this type of surgery.

To be eligible, participants must be able to follow the study's requirements and have a daily pain medication score of less than 25 before surgery. Those who are younger than 18, cannot commit to follow-up appointments, or have certain health conditions (like needing another surgery on the same area) will not be able to participate. Throughout the study, participants will receive care and follow-up at 2-3 weeks, 4-6 weeks, and 3 months after their surgery to monitor their recovery and pain levels. This is a great opportunity for patients to contribute to research that could help improve pain management for future patients undergoing similar surgeries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.