Comparison of preoperative and intraoperative pain management techniques for spine surgery
Randomized Controlled Comparison of Preoperative Ultrasound Guided TLIP Block Versus Intraoperative Non-ultrasound Guided TLIP Block
This study is testing whether giving a pain relief injection before or during spine surgery helps patients feel less pain afterward and use fewer opioids.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | William Beaumont Hospitals Academic / other |
| Locations | 1 site (Royal Oak, Michigan) |
| Trial ID | NCT06154980 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a single-center, randomized study enrolling 50 subjects scheduled for 1-3 level posterior laminectomy and fusion. Participants will be randomly assigned to receive either a preoperative or intraoperative ultrasound-guided thoracolumbar interfacial plane block (TLIP) to assess the impact on postoperative pain management. Data on demographics, pain levels, satisfaction, and opioid consumption will be collected at various intervals post-surgery to evaluate the effectiveness of each approach. The study aims to determine which timing of the TLIP provides better pain relief and reduces opioid use after surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who require a 1 to 3 level posterior laminectomy with fusion and have a low pre-operative opioid use.
Not a fit: Patients who are younger than 18 years, require revision surgery, or have high pre-operative opioid use may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing spine surgery, potentially reducing opioid consumption.
How similar studies have performed: Other studies have shown promising results with similar approaches to pain management in surgical settings, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Royal Oak, Michigan
- William Beaumont Hospital — Royal Oak, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Daniel Park, MD — William Beaumont Hospitals
- Study coordinator: Grace SanAgustin, RN
- Email: grace.sanagustin@corewellhealth.org
- Phone: 248-551-6679
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.