Randomized Controlled Comparison of Pre-op TLIP vs Intra-op TLIP
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Preoperative Ultrasound TLIP Group 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. |
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.
|
| Active Comparator: Intraoperative TLIP Group Participants will receive TLIP with 20cc of 0.2% ropivacaine bilaterally, 40cc total. Blocks will be performed intraoperatively under direct surgical visualization. |
Procedure: Intraoperative TLIP
TLIP will be performed intraoperatively with 20cc of 0.2% ropivacaine bilaterally, 40cc total. Blocks under direct surgical visualization.
|
Outcome Measures
Primary Outcome Measures
- Pain scores at admission to PACU [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 scores at admission to inpatient unit [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 discharge from hospital [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 2-3 weeks (VAS) [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.
- Pain score at 4-6 weeks (VAS) [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.
- Pain score at 3 months (VAS) [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.
- Pain score at 2-3 weeks (Likert) [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 score at 4-6 weeks (Likert) [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) [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 pain 24 hours after surgery [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.
- Change in back pain at 2-3 weeks [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 back pain at 4-6 weeks [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 back pain at 3 months [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 [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 right leg pain at 4-6 weeks [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 [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 left leg pain at 2-3 weeks [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 [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 [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.
- Opioid Consumption [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.
Secondary Outcome Measures
- Satisfaction at 3 months [3 months after surgery]
Satisfaction of surgical outcome will be measured using a 10 point Likert scale. The scale is 1 - 10 and a higher number indicates higher satisfaction with the surgical outcome. 1 is very unsatisfied and 10 is very satisfied.
- Satisfaction at 4-6 weeks [4-6 weeks after surgery]
Satisfaction of surgical outcome will be measured using a 10 point Likert scale. The scale is 1 - 10 and a higher number indicates higher satisfaction with the surgical outcome. 1 is very unsatisfied and 10 is very satisfied.
- Satisfaction at 2-3 weeks [2-3 weeks after surgery]
Satisfaction of surgical outcome will be measured using a 10 point Likert scale. The scale is 1 - 10 and a higher number indicates higher satisfaction with the surgical outcome. 1 is very unsatisfied and 10 is very satisfied.
- Number of Adverse Events [Surgery to 3 months]
Adverse events will be collected from the time of surgery through 3 months.
Eligibility Criteria
Criteria
Inclusion Criteria:
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greater than or equal to 18 years of age on the date of service
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require a 1 to 3 level posterior laminectomy with fusion
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compliant with study requirements and outpatient follow-up
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a daily MME less than 25 MME per day in the per-operative period
Exclusion Criteria:
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younger than 18 years of age on the date of service
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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
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requiring revision surgery at the same level for posterior laminectomy with fusion
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a daily MME score >25 MME/day in the pre-operative period will be excluded
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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
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ongoing lawsuits, workers compensation, and litigation will be excluded.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | William Beaumont Hospital | Royal Oak | Michigan | United States | 48073 |
Sponsors and Collaborators
- William Beaumont Hospitals
Investigators
- Principal Investigator: Daniel Park, MD, William Beaumont Hospitals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023-189