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

NCT06154980 | Withdrawn

• 1 other identifier: 2023-189
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Spine Fusion

Keywords

thoracolumbar interfacial plane block; lumbar spine fusion; posterior laminectomy with fusion

Outcome Measures

Primary Outcomes (20)

• 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.

  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

Secondary Outcomes (4)

• Satisfaction at 3 months

  3 months after surgery

• Satisfaction at 4-6 weeks

  4-6 weeks after surgery

• Satisfaction at 2-3 weeks

  2-3 weeks after surgery

• Number of Adverse Events

  Surgery to 3 months

Study Arms (2)

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.

Procedure: Preoperative Ultrasound TLIP

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.

Procedure: Intraoperative TLIP

Interventions

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.

Preoperative Ultrasound TLIP Group

Intraoperative TLIP PROCEDURE

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

Intraoperative TLIP Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Park, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Orthopedic Surgeon

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: December 4, 2023
• Study Start: October 28, 2024
• Primary Completion: October 21, 2025
• Study Completion: October 21, 2025
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)