Efficacy of TLIP Block for Postoperative Analgesia of Lumbar Spinal Fusion

NCT04593953 | Completed

• 1 other identifier: 2020/01
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 2

Brief Summary

Spinal surgery is associated with severe pain in the immediate postoperative period. In a recent study evaluating pain intensity on the first day after surgery in a large range of surgical procedures, among the six most painful surgeries, three were major spinal procedures. Spinal surgery causes an accumulation of several types of pain. Incisional pain results from activation of peripheral nociceptors. Musculoskeletal pain arises from damage to structures, such as bone, ligaments, muscles, intervertebral disks, and zygapophyseal joints. In addition, neuropathic pain arises from compression and damage to nerve roots exiting the spinal canal and sometimes damage to the spinal cord itself. Postoperative pain management requires multimodal analgesia, combining drugs and injection of a local anesthetic (LA) in order to reduce opioid consumption after surgery. Among regional anesthesia (RA) techniques, the thoraco-lumbar interfascial plane block (TLIP) was considered. It offers an effective and safe analgesia during the first 24h after herniated lumbar disc surgery. Ultrasound-guided TLIP block involves injection of LAs between longissimus and multifidus muscles (spinal lombar muscles). This injection allows to block the dorsal rami of spinal nerves innervating the paravertebral muscles and the vertebrae. The objective of this study is to evaluate the interest of TLIP block to improve the postoperative analgesia in patients undergoing lumbar spinal fusion surgery.

Conditions

Lumbar Spinal Fusion

Keywords

TLIP block; Lumbar spinal fusion; Regional anesthesia; Ropivacaine; Postoperative analgesia; Ultrasound; Pain management; Opioids

Outcome Measures

Primary Outcomes (1)

• Morphine consumption in the first 24 hours post-surgery

  Total amount of morphine (mg) administered during the first 24 hours post-surgery. The reference time t0 will be the time of skin incision.

  24 hours

Secondary Outcomes (7)

• Morphine consumption in the first 48 hours post-surgery

  48 hours

• Morphine consumption in the post-anesthesia care unit (PACU)

  6 hours

• Duration of postoperative analgesia

  48 hours

• Postoperative pain: Visual Analogue Scale (VAS)

  48 hours

• Postoperative quality of recovery

  72 hours

Study Arms (2)

CONTROL

NO INTERVENTION

Standard general anesthesia

TLIP

EXPERIMENTAL

Standard general anesthesia + TLIP block

Procedure: TLIP

Interventions

TLIP PROCEDURE

Injection of 40 ml of ropivacaine 0.25% (2 injections of 20 ml on each side) between multifidus and longissimus muscles.

TLIP

Eligibility Criteria

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

You may qualify if:

• ≥ 18 years old,
• Undergoing posterior lumbar spinal one-level or two-level fusion surgery (L3-L4, L4-L5 and/or L5-S1),
• Having signed a written informed consent form,
• Affiliation to the social security system.

You may not qualify if:

• Contraindication for regional anesthesia (allergy to local anesthetics, neuropathic disease, infection at the puncture site, coagulation disorder, refusal of the technique,…)
• Contraindication to nonsteroidal anti-inflammatory drugs,
• Patient who have already had a spinal surgery,
• Patient with chronic pain syndrome (use \> 3 months of morphine, opioid analgesics of class 3, pregabalin or gabapentin) or fibromyalgia,
• A mental or linguistic inability to understand the study,
• Patient under protection of the adults (guardianship, curators or safeguard of justice),
• Pregnant or or breastfeeding women.

Sponsors & Collaborators

• CMC Ambroise Paré: lead

Study Sites (2)

Hôpital Privé Jean Mermoz

Lyon, 69008, France

Location

CMC Ambroise Paré

Neuilly-sur-Seine, Île-de-France Region, 92200, France

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: To minimize assessment bias, patients and evaluators (nurse and physiotherapist) will be unaware of the intervention group. Only the investigator, who will include the patient and will realize the procedure, will know the arm of randomization.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 20, 2020
• Study Start: February 8, 2021
• Primary Completion: June 29, 2022
• Study Completion: July 1, 2022
• Last Updated: July 7, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)