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Physician is leaving the institution and it will not be continued.
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative Ultrasound TLIP Group | Active Comparator | 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. |
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| Intraoperative TLIP Group | Active Comparator | Participants will receive TLIP with 20cc of 0.2% ropivacaine bilaterally, 40cc total. Blocks will be performed intraoperatively under direct surgical visualization. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative Ultrasound TLIP | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain scores at admission to PACU | 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. | Baseline (up to 30 days prior to surgery) to PACU admission (immediately post-operative) |
| Pain scores at admission to inpatient unit | 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. | At inpatient unit admission (within 24 hours after surgery) |
| Pain score at discharge from hospital | 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. | At hospital discharge (within 3 days of hospital discharge) |
| Pain score at 2-3 weeks (VAS) | 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. | 2-3 weeks after surgery |
| Pain score at 4-6 weeks (VAS) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction at 3 months | 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. | 3 months after surgery |
| Satisfaction at 4-6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Park, MD | Corewell Health East | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
Study withdrawn, no individual participant data to share.
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Intraoperative TLIP | Procedure | TLIP will be performed intraoperatively with 20cc of 0.2% ropivacaine bilaterally, 40cc total. Blocks under direct surgical visualization. |
|
| 4-6 weeks after surgery |
| Pain score at 3 months (VAS) | 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. | 3 months after surgery |
| Pain score at 2-3 weeks (Likert) | 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. | 2-3 weeks after surgery |
| Pain score at 4-6 weeks (Likert) | 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. | 4-6 weeks after surgery |
| Pain score at 3 months (Likert) | 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. | 3 months after surgery |
| Change in pain 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. | 24 hours after surgery |
| Change in back pain at 2-3 weeks | 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. | 2-3 weeks after surgery |
| Change in back pain at 4-6 weeks | 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. | 4-6 weeks after surgery |
| Change in back pain at 3 months | 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. | 3 months after surgery |
| Change in right leg pain at 2-3 weeks | 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. | 2-3 weeks after surgery |
| Change in right leg pain at 4-6 weeks | 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. | 4-6 weeks after surgery |
| Change in right leg pain at 3 months | 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. | 3 months after surgery |
| Change in left leg pain at 2-3 weeks | 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. | 2-3 weeks after surgery |
| Change in left leg pain at 4-6 weeks | 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. | 4-6 weeks after surgery |
| Change in left leg pain at 3 months | 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. | 3 months after surgery |
| Opioid Consumption | 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. | PACU arrival through 3 months |
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. |
| 4-6 weeks after surgery |
| Satisfaction at 2-3 weeks | 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. | 2-3 weeks after surgery |
| Number of Adverse Events | Adverse events will be collected from the time of surgery through 3 months. | Surgery to 3 months |