- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04593953
Efficacy of TLIP Block for Postoperative Analgesia of Lumbar Spinal Fusion (ETLA)
Efficacy of Thoraco-Lumbar Interfascial Plane (TLIP) Block for Postoperative Analgesia of Lumbar Spinal Fusion
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.
Study Overview
Detailed Description
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
General anesthesia will be standardized in the two groups:
- Induction with propofol 2-3 mg/kg, sufentanyl 0.2-0.3 µg/kg and ketamine 0.3 mg/kg
- Intubation facilitated according centre's protocol and ventilation performed with 50% oxygen and 50% air in order to maintain normocapnia and normoxia.
- Anesthesia maintained according to the centre's usual care.
Prevention of postoperative nausea and vomiting (NVPO) according centre's protocol.
- TLIP block technique ("TLIP" group only) The regional anesthesia procedure will be performed under general anesthesia and will be guided by ultrasound with high-frequency linear probe, patient in prone position or genupectoral (knee-chest) position. The probe will be positioned in order to have an axial view of lumbar vertebrae. The 3rd lumbar vertebra (L3), the 4th lumbar vertebra (L4) and the 5th lumbar vertebra (L5) will be identified after initial identification of the sacrum. A needle will be inserted in plane (IP) and advanced to reach the interspace between the multifidus and the longissimus muscles on the tip of the articular process. For each patient, the block will be performed bilaterally by injecting of 20 ml of Ropivacaine 0.25% on each side. Before each procedure, a skin disinfection will be carried out using an alcoholic iodine solution.
Patients will not receive any LA by intravenous injection or infiltration.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lyon, France, 69008
- Hopital Prive Jean Mermoz
-
-
Ile-de-France
-
Neuilly-sur-Seine, Ile-de-France, France, 92200
- CMC Ambroise Paré
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ≥ 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: CONTROL
Standard general anesthesia
|
|
Experimental: TLIP
Standard general anesthesia + TLIP block
|
Injection of 40 ml of ropivacaine 0.25% (2 injections of 20 ml on each side) between multifidus and longissimus muscles.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Morphine consumption in the first 24 hours post-surgery
Time Frame: 24 hours
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Morphine consumption in the first 48 hours post-surgery
Time Frame: 48 hours
|
Total amount of morphine (mg) administered during the first 48 hours post-surgery
|
48 hours
|
Morphine consumption in the post-anesthesia care unit (PACU)
Time Frame: 6 hours
|
Total amount of morphine (mg) administered in PACU
|
6 hours
|
Duration of postoperative analgesia
Time Frame: 48 hours
|
Time (in minutes) between the skin incision (t0) and the first administration of morphine in PACU or in ward.
|
48 hours
|
Postoperative pain: Visual Analogue Scale (VAS)
Time Frame: 48 hours
|
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).
|
48 hours
|
Postoperative quality of recovery
Time Frame: 72 hours
|
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.
|
72 hours
|
Side effects associated with opioids
Time Frame: 72 hours
|
Incidence of side effects associated with morphine: nausea and vomiting, drowsiness, acute urinary retention.
|
72 hours
|
Rate of complications
Time Frame: 20 minutes, 72 hours
|
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. |
20 minutes, 72 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2020/01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lumbar Spinal Fusion
-
National Taiwan University HospitalTerminatedLumbar Fusion | Lumbar Spinal Fusion SurgeryTaiwan
-
Clinique Saint Jean, FranceRecruiting
-
State University of New York - Upstate Medical...DePuy-Acromed, Inc.CompletedSpinal Fusion | Lumbar DiscectomyUnited States
-
Yonsei UniversityCompletedElective Posterior Lumbar Spinal FusionKorea, Republic of
-
Yonsei UniversityCompletedPosterior Lumbar Spinal Fusion SurgeryKorea, Republic of
-
Taipei Veterans General Hospital, TaiwanCompletedReadmission | Lumbar Spinal Fusion | Early DischargeTaiwan
-
Ilse van de WijgertRadboud University Medical CenterCompletedLumbar Disc Herniation | Lumbar Spinal Stenosis | Fusion of Spine | Spinal Fusion | Lumbar Spondylolisthesis | Spondylolisthesis | Lumbar Disc Disease | Lumbar Spondylosis | Lumbar Spine Disease | Lumbar Radiculitis | Spondylosis Lumbosacral RegionNetherlands
-
Taipei Veterans General Hospital, TaiwanCompletedDegenerative Lumbar Spinal Stenosis | Lumbarsacral Orthosis | Transforaminal Lumbar Interbody FusionTaiwan
-
University of KentuckyRecruitingSpinal Fusion | Spondylolisthesis | Arthrodesis | Pseudarthrosis | Lumbar FusionUnited States
-
Medtronic Spinal and BiologicsRecruitingIntervertebral Disc Degeneration | Spinal Fusion | Lumbar Disc DiseaseKorea, Republic of
Clinical Trials on TLIP
-
William Beaumont HospitalsRecruiting
-
Aydin Adnan Menderes UniversityUnknown
-
Indonesia UniversityRecruitingLumbar Posterior DecompressionIndonesia
-
Medipol UniversityCompleted
-
Tanta UniversityUnknownPostoperative Pain | Erector Spinae Plane Block | Ultrasound | Lumbar Laminectomy | Thoracolumbar Interfascial Plane BlockEgypt
-
Eslam Ayman Mohamed ShawkiCompleted
-
Ain Shams UniversityRecruiting
-
Cairo UniversityCompletedPostoperative PainEgypt
-
Hanoi Medical UniversityCompletedAnalgesia | Spine FusionVietnam
-
University of IowaNot yet recruitingDelirium | Spinal Fusion | Pain, Back | Thoracolumbar Interfascial Plane BlockUnited States