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

William Beaumont Hospitals

Status: Withdrawn

Conditions: Spine Fusion; Pain

Treatments: Procedure: Preoperative Ultrasound TLIP; Procedure: Intraoperative TLIP

Study type: Interventional

Funder types: Other

Identifiers

NCT06154980

2023-189

Details and patient eligibility

About

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.

Full 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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Preoperative Ultrasound TLIP Group

Active Comparator group

Description:

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.

Treatment:

Procedure: Preoperative Ultrasound TLIP

Intraoperative TLIP Group

Active Comparator group

Description:

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

Treatment:

Procedure: Intraoperative TLIP