Lumbar Spinal FusionETLANCT04593953
Efficacy of TLIP Block for Postoperative Analgesia of Lumbar Spinal Fusion
A study testing TLIP in people with Lumbar Spinal Fusion, run by CMC Ambroise Paré at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Spinal Fusion
- What is being tested?
- TLIP
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 2 sitesFrance
- Study dates
- 8 Feb 2021to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Privé Jean Mermoz
Lyon, 69008
CMC Ambroise Paré
Neuilly-sur-Seine, Île-de-France Region, 92200
About this study
Official title: 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.
Read the 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.
- Conditions
- Lumbar Spinal Fusion
- Being tested
- TLIP
- Keywords
- TLIP block, Lumbar spinal fusion, Regional anesthesia, Ropivacaine, Postoperative analgesia, Ultrasound, Pain management, Opioids
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLIPProcedure or surgery
Injection of 40 ml of ropivacaine 0.25% (2 injections of 20 ml on each side) between multifidus and longissimus muscles.
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | No intervention | Standard general anesthesia |
| TLIP | Experimental | Standard general anesthesia + TLIP block Receives: Procedure: TLIP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (7)
Morphine consumption in the first 48 hours post-surgery
Total amount of morphine (mg) administered during the first 48 hours post-surgery
Measured: 48 hours
Morphine consumption in the post-anesthesia care unit (PACU)
Total amount of morphine (mg) administered in PACU
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 72 hours
Side effects associated with opioids
Incidence of side effects associated with morphine: nausea and vomiting, drowsiness, acute urinary retention.
Measured: 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.
Measured: 20 minutes, 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start8 Feb 2021
- Primary completion29 Jun 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal FusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMC Ambroise Paré
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593953
- Sponsor's protocol ID
- 2020/01
- Acronym
- ETLA
- Status last verified
- Jul 2022
- First submitted
- 13 Oct 2020
- Last updated
- 7 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Thoraco-Lumbar Interfascial Plane (TLIP) Block for Postoperative Analgesia of Lumbar Spinal Fusion
- ClinicalTrials.gov ID
- NCT04593953
- Acronym / sponsor ID
- ETLA / 2020/01
- Conditions
- Lumbar Spinal Fusion
- Keywords
- TLIP block, Lumbar spinal fusion, Regional anesthesia, Ropivacaine, Postoperative analgesia, Ultrasound, Pain management, Opioids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 29 Jun 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTROL | No intervention | –Standard general anesthesia |
| TLIP | Experimental | Procedure: TLIPStandard general anesthesia + TLIP block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TLIPInjection of 40 ml of ropivacaine 0.25% (2 injections of 20 ml on each side) between multifidus and longissimus muscles. | Procedure or surgery | TLIP |
Primary outcome
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.
7 secondary outcomes
Morphine consumption in the first 48 hours post-surgery
Time frame: 48 hours
Morphine consumption in the post-anesthesia care unit (PACU)
Time frame: 6 hours
Duration of postoperative analgesia
Time frame: 48 hours
Postoperative pain: Visual Analogue Scale (VAS)
Time frame: 48 hours
Postoperative quality of recovery
Time frame: 72 hours
Side effects associated with opioids
Time frame: 72 hours
Rate of complications
Time frame: 20 minutes, 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TLIP in people with Lumbar Spinal Fusion, run by CMC Ambroise Paré at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine consumption in the first 24 hours post-surgery (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2022.