Clinical trial NCT06154980: Randomized Controlled Comparison of Pre-op TLIP Vs Intra-op TLIP
Official title: Randomized Controlled Comparison of Preoperative Ultrasound Guided TLIP Block Versus Intraoperative Non-ultrasound Guided TLIP Block
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Spine Fusion
Keywords: thoracolumbar interfacial plane block
lumbar spine fusion
posterior laminectomy with fusion
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2023-12-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Eligibility 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.

Primary outcomes:
measure: Pain scores at admission to PACU
timeFrame: Baseline (up to 30 days prior to surgery) to PACU admission (immediately post-operative)
measure: Pain scores at admission to inpatient unit
timeFrame: At inpatient unit admission (within 24 hours after surgery)
measure: Pain score at discharge from hospital
timeFrame: At hospital discharge (within 3 days of hospital discharge)
measure: Pain score at 2-3 weeks (VAS)
timeFrame: 2-3 weeks after surgery
measure: Pain score at 4-6 weeks (VAS)
timeFrame: 4-6 weeks after surgery
measure: Pain score at 3 months (VAS)
timeFrame: 3 months after surgery
measure: Pain score at 2-3 weeks (Likert)
timeFrame: 2-3 weeks after surgery
measure: Pain score at 4-6 weeks (Likert)
timeFrame: 4-6 weeks after surgery
measure: Pain score at 3 months (Likert)
timeFrame: 3 months after surgery
measure: Change in pain 24 hours after surgery
timeFrame: 24 hours after surgery
measure: Change in back pain at 2-3 weeks
timeFrame: 2-3 weeks after surgery
measure: Change in back pain at 4-6 weeks
timeFrame: 4-6 weeks after surgery
measure: Change in back pain at 3 months
timeFrame: 3 months after surgery
measure: Change in right leg pain at 2-3 weeks
timeFrame: 2-3 weeks after surgery
measure: Change in right leg pain at 4-6 weeks
timeFrame: 4-6 weeks after surgery
measure: Change in right leg pain at 3 months
timeFrame: 3 months after surgery
measure: Change in left leg pain at 2-3 weeks
timeFrame: 2-3 weeks after surgery
measure: Change in left leg pain at 4-6 weeks
timeFrame: 4-6 weeks after surgery
measure: Change in left leg pain at 3 months
timeFrame: 3 months after surgery
measure: Opioid Consumption
timeFrame: PACU arrival through 3 months
Secondary outcomes:
measure: Satisfaction at 3 months
timeFrame: 3 months after surgery
measure: Satisfaction at 4-6 weeks
timeFrame: 4-6 weeks after surgery
measure: Satisfaction at 2-3 weeks
timeFrame: 2-3 weeks after surgery
measure: Number of Adverse Events
timeFrame: Surgery to 3 months
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Daniel Park, MD
role: PRINCIPAL_INVESTIGATOR
References: