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Procedure

Pre-op vs Intra-op TLIP for Spinal Fusion

N/A

Recruiting

Led By Daniel Park, MD

Research Sponsored by William Beaumont Hospitals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A daily MME less than 25 MME per day in the per-operative period

Greater than or equal to 18 years of age on the date of service

Timeline

Screening 3 weeks

Treatment Varies

Follow Up surgery to 3 months

Awards & highlights

Study Summary

This trial will study 50 people having back surgery and is stratified based on age and gender to ensure equal distribution.

Who is the study for?

This trial is for adults over 18 needing a specific back surgery (1-3 level posterior laminectomy with fusion) and taking low doses of pain medication. They must agree to follow the study plan and attend check-ups after surgery. People under 18, not consenting, requiring revision surgery, using certain drugs, or involved in lawsuits can't join.Check my eligibility

What is being tested?

The study compares two timing approaches for administering TLIP anesthesia: one before surgery (Pre-op) and another during the operation (Intra-op). It's designed to see which method works better for pain management in spinal fusion patients.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include typical anesthesia-related risks such as nausea, vomiting, sore throat, dizziness, headache, or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I take less than 25 MME of pain medication daily before surgery.

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I am 18 years old or older.

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I need a specific spine surgery involving 1 to 3 levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ surgery to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~surgery to 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and surgery to 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in back pain at 2-3 weeks

Change in back pain at 3 months

Change in back pain at 4-6 weeks

+17 more

Secondary outcome measures

Number of Adverse Events

Satisfaction at 2-3 weeks

Satisfaction at 3 months

+1 more

Trial Design

2Treatment groups

Active Control

Group I: Preoperative Ultrasound TLIP GroupActive Control1 Intervention

Participant will receive TLIP in preop with 20cc of 0.2% ropivacaine administered bilaterally, 40cc total. Blocks will be performed under ultrasound guidance with an in-plane technique by a single study investigator.

Group II: Intraoperative TLIP GroupActive Control1 Intervention

Participants will receive TLIP with 20cc of 0.2% ropivacaine bilaterally, 40cc total. Blocks will be performed intraoperatively under direct surgical visualization.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

William Beaumont HospitalsLead Sponsor

149 Previous Clinical Trials

112,808 Total Patients Enrolled

Daniel Park, MDPrincipal InvestigatorWilliam Beaumont Hospitals

1 Previous Clinical Trials

300 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit of participants for this research endeavor?

"Yes, the information hosted on clinicaltrials.gov supports that this medical trial is actively recruiting patients. Since first being posted on January 1st 2024, it has been updated as recently as December 1st 2023 and now requires 50 participants to be enrolled from a single site."

Answered by AI

Are there still vacancies available to take part in this research?

"As per the data published on clinicaltrials.gov, this research is actively recruiting volunteers. It was originally announced on January 1st 2024 and recently updated on December 1st 2023."

Answered by AI

What objectives is this trial seeking to attain?

"This clinical trial, which will extend over a period of 4-6 weeks post surgery, has set out to assess the 24 hour change in pain levels as its primary objective. Secondary measures include patient satisfaction at 3 month and 4-6 week intervals, alongside any adverse events recorded within three months following surgery. The 10 point Likert scale ranging from 1 (very unsatisfied) to 10 (very satisfied) will be used when assessing satisfaction with surgical outcomes."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Daniel K Park 2024. "Randomized Controlled Comparison of Pre-op TLIP vs Intra-op TLIP". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06154980.