NCT06154980

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

Randomized Controlled Comparison of Preoperative Ultrasound Guided TLIP Block Versus Intraoperative Non-ultrasound Guided TLIP Block

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Corewell Health East · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single-center, randomized study. The study will enroll 50 subjects who are scheduled for 1-3 level posterior laminectomy \& fusion. Potential participants who are eligible for the posterior lumbar laminectomy and fusion procedure will be scheduled as a study participant, consented as a part of the study, and stratified based on age and gender to ensure equal distribution. For each participant, demographics including age, sex, smoking and alcohol use history, body mass index (BMI), Cranial Cervical Instability (CCI), American Society of Anesthesiology classification (ASA), prior opioid use for pain management, pain levels, function, and prior history of other spinal surgery will be collected prior to surgery. Participants will be randomly assigned to one of two treatment groups: Pre-op ultrasound Thoracolumbar Interfacial Plane Block (TLIP) group or Intra-operative Thoracolumbar Interfacial Plane Block (TLIP) group. The participant will then undergo the planned 1 to 3 level posterior lumbar laminectomy and fusion procedure. Post-operative opioid analgesia will be assessed using the Visual Analog Scale (VAS) upon arrival to the post-anesthesia unit (PACU) until discharge and in the outpatient setting. Pain, satisfaction, and opioid analgesia consumption will also be assessed at 2-3 weeks post-operatively, 4-6 weeks post-operatively, and 3 months post-operatively. Pain will be assessed using VAS. Satisfaction will be assessed using a Likert scale. Opioid analgesia is defined as oxycodone, oxymorphone, hydrocodone, hydromorphone, fentanyl, morphine, codeine, methadone, tramadol, and buprenorphine. Opioid consumption will be measured in morphine milligram equivalents (MME).

Conditions

• Pain
• Spine Fusion

Interventions

Type	Name	Description
PROCEDURE	Preoperative Ultrasound TLIP	TLIP will be performed in preop with 20cc of 0.2% ropivacaine administered bilaterally, 40cc total. Blocks will be performed under ultrasound guidance with an in-plane technique.
PROCEDURE	Intraoperative TLIP	TLIP will be performed intraoperatively with 20cc of 0.2% ropivacaine bilaterally, 40cc total. Blocks under direct surgical visualization.

Timeline

• Start date: 2024-10-28
• Primary completion: 2025-10-21
• Completion: 2025-10-21
• First posted: 2023-12-04
• Last updated: 2025-10-23

Locations

1 site across 1 country: United States