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

Pain Clinical Trial

Official title:

Randomized Controlled Comparison of Preoperative Ultrasound Guided TLIP Block Versus Intraoperative Non-ultrasound Guided TLIP Block

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06154980
• Other study ID #: 2023-189
• Status: Recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: March 2025

Study information

• Verified date: January 2024
• Source: William Beaumont Hospitals
• Contact: Grace SanAgustin, RN
• Phone: 248-551-6679
• Email: grace.sanagustin[@]corewellhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain
• Spine Fusion

Intervention

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

Locations

Country	Name	City	State
United States	William Beaumont Hospital	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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
Primary	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.	4-6 weeks after surgery
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	Satisfaction at 4-6 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.	4-6 weeks after surgery
Secondary	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
Secondary	Number of Adverse Events	Adverse events will be collected from the time of surgery through 3 months.	Surgery to 3 months