Randomized Controlled Comparison of Preoperative Ultrasound Guided TLIP Block Versus Intraoperative Non-ultrasound Guided TLIP Block
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Corewell Health East
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Pain score at 2-3 weeks (Likert)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Pain score at 2-3 weeks (Likert)
Time Frame: 2-3 weeks after surgery
Post-operative pain will be measured using a 10 point Likert pain score. The scale is 1 - 10 and a lower number indicates less pain. 1 is no pain and 10 is intense pain.
Pain scores at admission to inpatient unit
Time Frame: At inpatient unit admission (within 24 hours after surgery)
Post operative pain scores will be measured using visual analog scale (VAS) scores at admission to inpatient unit after surgery. The scale is 0-10 with a lower score indicating less pain. A score of 0 indicates no pain and a score of 10 indicates severe pain.
Pain score at 4-6 weeks (Likert)
Time Frame: 4-6 weeks after surgery
Post-operative pain will be measured using a 10 point Likert pain score. The scale is 1 - 10 and a lower number indicates less pain. 1 is no pain and 10 is intense pain.
Pain score at 3 months (Likert)
Time Frame: 3 months after surgery
Post-operative pain will be measured using a 10 point Likert pain score. The scale is 1 - 10 and a lower number indicates less pain. 1 is no pain and 10 is intense pain.
Change in left leg pain at 2-3 weeks
Time Frame: 2-3 weeks after surgery
The change of VAS score from the score at the time of post anesthesia care unit (PACU) arrival to 2-3 weeks after surgery. Pain scores will be measured using visual analog scale (VAS) scores at the 2-3 week follow-up. The scale is 0-10 with a lower score indicating less pain. A score of 0 indicates no pain and a score of 10 indicates severe pain.
Pain score at 2-3 weeks (VAS)
Time Frame: 2-3 weeks after surgery
Post operative pain scores will be measured using visual analog scale (VAS) scores at the 2-3 week follow-up. The scale is 0-10 with a lower score indicating less pain. A score of 0 indicates no pain and a score of 10 indicates severe pain.
Change in back pain at 3 months
Time Frame: 3 months after surgery
The change of VAS score from the score at the time of post anesthesia care unit (PACU) arrival to 3 months after surgery. Pain scores will be measured using visual analog scale (VAS) scores at the 3 month follow-up. The scale is 0-10 with a lower score indicating less pain. A score of 0 indicates no pain and a score of 10 indicates severe pain.
Change in right leg pain at 2-3 weeks
Time Frame: 2-3 weeks after surgery
The change of VAS score from the score at the time of post anesthesia care unit (PACU) arrival to 2-3 weeks after surgery. Pain scores will be measured using visual analog scale (VAS) scores at the 2-3 week follow-up. The scale is 0-10 with a lower score indicating less pain. A score of 0 indicates no pain and a score of 10 indicates severe pain.
Change in left leg pain at 4-6 weeks
Time Frame: 4-6 weeks after surgery
The change of VAS score from the score at the time of post anesthesia care unit (PACU) arrival to 4-6 weeks after surgery. Pain scores will be measured using visual analog scale (VAS) scores at the 4-6 week follow-up. The scale is 0-10 with a lower score indicating less pain. A score of 0 indicates no pain and a score of 10 indicates severe pain.
Change in left leg pain at 3 months
Time Frame: 3 months after surgery
The change of VAS score from the score at the time of post anesthesia care unit (PACU) arrival to 3 months after surgery. Pain scores will be measured using visual analog scale (VAS) scores at the 3 month follow-up. The scale is 0-10 with a lower score indicating less pain. A score of 0 indicates no pain and a score of 10 indicates severe pain.
Pain score at discharge from hospital
Time Frame: At hospital discharge (within 3 days of hospital discharge)
Post operative pain scores will be measured using visual analog scale (VAS) scores at every 8 hours after admission to an inpatient unit until discharge. The scale is 0-10 with a lower score indicating less pain. A score of 0 indicates no pain and a score of 10 indicates severe pain.
Pain score at 3 months (VAS)
Time Frame: 3 months after surgery
Post operative pain scores will be measured using visual analog scale (VAS) scores at the 3 month follow-up. The scale is 0-10 with a lower score indicating less pain. A score of 0 indicates no pain and a score of 10 indicates severe pain.
Change in right leg pain at 4-6 weeks
Time Frame: 4-6 weeks after surgery
The change of VAS score from the score at the time of post anesthesia care unit (PACU) arrival to 4-6 weeks after surgery. Pain scores will be measured using visual analog scale (VAS) scores at the 4-6 week follow-up. The scale is 0-10 with a lower score indicating less pain. A score of 0 indicates no pain and a score of 10 indicates severe pain.
Pain scores at admission to PACU
Time Frame: Baseline (up to 30 days prior to surgery) to PACU admission (immediately post-operative)
Post operative pain scores will be measured using visual analog scale (VAS) scores at admission to PACU after surgery. The scale is 0-10 with a lower score indicating less pain. A score of 0 indicates no pain and a score of 10 indicates severe pain.
Pain score at 4-6 weeks (VAS)
Time Frame: 4-6 weeks after surgery
Post operative pain scores will be measured using visual analog scale (VAS) scores at the 4-6 week follow-up. The scale is 0-10 with a lower score indicating less pain. A score of 0 indicates no pain and a score of 10 indicates severe pain.
Change in back pain at 4-6 weeks
Time Frame: 4-6 weeks after surgery
The change of VAS score from the score at the time of post anesthesia care unit (PACU) arrival to 4-6 weeks after surgery. Pain scores will be measured using visual analog scale (VAS) scores at the 4-6 week follow-up. The scale is 0-10 with a lower score indicating less pain. A score of 0 indicates no pain and a score of 10 indicates severe pain.
Change in right leg pain at 3 months
Time Frame: 3 months after surgery
The change of VAS score from the score at the time of post anesthesia care unit (PACU) arrival to 3 months after surgery. Pain scores will be measured using visual analog scale (VAS) scores at the 3 month follow-up. The scale is 0-10 with a lower score indicating less pain. A score of 0 indicates no pain and a score of 10 indicates severe pain.
Change in pain 24 hours after surgery
Time Frame: 24 hours after surgery
The change of VAS score from the score at the time of post anesthesia care unit (PACU) arrival to 24 hours after surgery. Pain scores will be measured using visual analog scale (VAS) scores. The scale is 0-10 with a lower score indicating less pain. A score of 0 indicates no pain and a score of 10 indicates severe pain.
Opioid Consumption
Time Frame: PACU arrival through 3 months
Opioid consumption will be measured in morphine milligram equivalents (MME). This is defined as the amount of milligrams of morphine an opioid dose is equal to. Opioid consumption measured in MME will be collected from PACU through 3 month follow up.
Change in back pain at 2-3 weeks
Time Frame: 2-3 weeks after surgery
The change of VAS score from the score at the time of post anesthesia care unit (PACU) arrival to 2-3 weeks after surgery. Pain scores will be measured using visual analog scale (VAS) scores at the 2-3 week follow-up. The scale is 0-10 with a lower score indicating less pain. A score of 0 indicates no pain and a score of 10 indicates severe pain.
Secondary Outcomes
- Satisfaction at 2-3 weeks(2-3 weeks after surgery)
- Satisfaction at 3 months(3 months after surgery)
- Satisfaction at 4-6 weeks(4-6 weeks after surgery)
- Number of Adverse Events(Surgery to 3 months)
Investigators
Daniel K Park
MD, Orthopedic Surgeon
Corewell Health East