WithdrawnNot Applicable

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

Stopped: Physician is leaving the institution and it will not be continued.

United States0Started 2024-10-28

Plain-language 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 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain scores at admission to PACU

Timeframe: Baseline (up to 30 days prior to surgery) to PACU admission (immediately post-operative)

Pain scores at admission to inpatient unit

Timeframe: At inpatient unit admission (within 24 hours after surgery)

Pain score at discharge from hospital

Timeframe: At hospital discharge (within 3 days of hospital discharge)

Pain score at 2-3 weeks (VAS)

Timeframe: 2-3 weeks after surgery

Pain score at 4-6 weeks (VAS)

Timeframe: 4-6 weeks after surgery

Pain score at 3 months (VAS)

Timeframe: 3 months after surgery

Pain score at 2-3 weeks (Likert)

Timeframe: 2-3 weeks after surgery

Trial details

NCT IDNCT06154980

SponsorCorewell Health East

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-21

View on ClinicalTrials.gov More Pain trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Pain scores at admission to PACU

Timeframe: Baseline (up to 30 days prior to surgery) to PACU admission (immediately post-operative)

Pain scores at admission to inpatient unit

Timeframe: At inpatient unit admission (within 24 hours after surgery)

Pain score at discharge from hospital

Timeframe: At hospital discharge (within 3 days of hospital discharge)

Pain score at 2-3 weeks (VAS)

Timeframe: 2-3 weeks after surgery

Pain score at 4-6 weeks (VAS)

Timeframe: 4-6 weeks after surgery

Pain score at 3 months (VAS)

Timeframe: 3 months after surgery

Pain score at 2-3 weeks (Likert)

Timeframe: 2-3 weeks after surgery