An interventional study of TLIP in Lumbar Spinal Fusion, sponsored by CMC Ambroise Paré. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-07.
Sponsored by CMC Ambroise Paré · Not applicable, Interventional, and Other
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.
This is a multicenter, randomized, double-blind (participant and care provider assessing outcomes), parallel-group controlled, trial assessing the interest of the association of TLIP block to general anesthesia for postoperative analgesia management in patients undergoing posterior lumbar spinal fusion.
This study compares two groups:
"Control" group: standard general anesthesia. "TLIP" group: standard general anesthesia + TLIP block with an injection of 40 ml of ropivacaine 0.25% (2 injections of 20 ml on each side) between multifidus and longissimus muscles.
General anesthesia will be standardized in the two groups:
Prevention of postoperative nausea and vomiting (NVPO) according centre's protocol.
Patients will not receive any LA by intravenous injection or infiltration.
CMC Ambroise Paré is the lead sponsor of 47 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard general anesthesia
Standard general anesthesia + TLIP block
Procedure: TLIP
Injection of 40 ml of ropivacaine 0.25% (2 injections of 20 ml on each side) between multifidus and longissimus muscles.
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.
Time frame: 24 hours
Morphine consumption in the first 48 hours post-surgery
Total amount of morphine (mg) administered during the first 48 hours post-surgery
Time frame: 48 hours
Morphine consumption in the post-anesthesia care unit (PACU)
Total amount of morphine (mg) administered in PACU
Time frame: 6 hours
Duration of postoperative analgesia
Time (in minutes) between the skin incision (t0) and the first administration of morphine in PACU or in ward.
Time frame: 48 hours
Postoperative pain: Visual Analogue Scale (VAS)
Pain scores using a Visual Analogue Scale (VAS) ranging from 0 to 10 (0= no pain; 10= worst imaginable pain). These scores will be recorded before surgery, in PACU and four times a day (morning, afternoon, evening and night) during the first 48 hours post-surgery, both at rest and during exercises (walk with the physiotherapist).
Time frame: 48 hours
Postoperative quality of recovery
15-item Quality of Recovery (QoR-15) scale ranging from 0 to 10 (0= very poor recovery; 150= excellent recovery). This multidimensional questionnaire assesses five domains of patient-reported health status: pain, physical comfort, physical independence, psychological support and emotional state.
Time frame: 72 hours
Side effects associated with opioids
Incidence of side effects associated with morphine: nausea and vomiting, drowsiness, acute urinary retention.
Time frame: 72 hours
Rate of complications
Poor distribution of local anesthetic and rhythm disorders linked to an intravascular injection assessed during regional anesthesia procedure and during the 20 minutes following the block. Infection at the injection site and mechanical complications: hematoma, assessed 72h post-surgery.
Time frame: 20 minutes, 72 hours
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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CMC Ambroise Paré