Single-level Lumbar ArthrodesisLIBERANCT07895368
Intravenous Lidocaine Versus Erector Spinae Plane Block After Lumbar Arthrodesis (LIBERA)
A study testing Single-level posterior lumbar arthrodesis in people with Single-level Lumbar Arthrodesis, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The hypothesis of this study is that intraoperative intravenous lidocaine infusion provides postoperative analgesia and opioid-sparing effects that are at least equivalent to those achieved with a bilateral erector spinae plane block, while offering a simpler and faster procedure that does not require ultrasound… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Single-level Lumbar Arthrodesis
- What is being tested?
- Single-level posterior lumbar arthrodesis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2026to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Male or female patients aged ≥18 years.
- Patients who have read, understood, and signed the informed consent form prior to any study-specific procedure.
- Patients scheduled to undergo a single-level posterior lumbar fusion for lumbar spinal stenosis, degenerative spondylolisthesis, or unstable degenerative disc disease.
- Body weight between 50 and 120 kg.
- ASA physical status classification ≤ III.
Who cannot join
- Emergency surgery.
- Reoperation of the surgical site.
- Contraindication to local anesthetics.
- Contraindication to NSAIDs.
- Coagulation disorder.
- Severe chronic renal or hepatic impairment.
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- Patients under legal protection.
- Lack of affiliation with the French social security system.
- Participation in another interventional clinical study that could interfere with the evaluation of analgesic treatments or interpretation of the study outcomes.
- Pregnant or breastfeeding women.
- Women of childbearing potential not using an effective method of contraception.
- Inability to understand study-related information or provide written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Postoperative Analgesia Provided by Intravenous Lidocaine and Erector Spinae Plane Block Following Posterior Lumbar Arthrodesis
The hypothesis of this study is that intraoperative intravenous lidocaine infusion provides postoperative analgesia and opioid-sparing effects that are at least equivalent to those achieved with a bilateral erector spinae plane block, while offering a simpler and faster procedure that does not require ultrasound guidance and whose efficacy is not dependent on operator expertise or on the uncertain spread of local anesthetic injection in the lumbar region.
- Conditions
- Single-level Lumbar Arthrodesis
- Being tested
- Single-level posterior lumbar arthrodesis
- Keywords
- Posterior Lumbar Arthrodesis, Analgesic efficacy of intravenous lidocaine, Analgesic efficacy of erector spinae plane block, IV opioid consumption equivalent during the 48 postoperative hours
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-level posterior lumbar arthrodesisProcedure or surgery
Lumbar arthrodesis is a surgical procedure designed to achieve permanent fusion of one or more segments of the lumbar spine by immobilizing the corresponding intervertebral joints.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 : Intraoperative Intravenous Lidocaine | Experimental | In accordance with current consensus recommendations on the use of intravenous lidocaine, patients allocated to the lidocaine group will receive an intraoperative intravenous lidocaine infusion under general anesthesia. Administration will consist of a loading dose of 1.5 mg/kg delivered over 10 minutes, followed by a continuous infusion at a rate of 2.0 mg/kg/h using a syringe pump throughout the surgical procedure. The infusion will be stopped at the completion of surgery, defined as wound closure. Receives: Procedure: Single-level posterior lumbar arthrodesis |
| Erector Spinae Plane Block | Other | Patients allocated to the Erector Spinae Plane (ESP) block group will undergo a bilateral ultrasound-guided erector spinae plane block after induction of general anesthesia and placement in the prone position for surgery. The erector spinae muscles and lumbar transverse processes will be identified using ultrasound, with the probe positioned 2-3 cm lateral to the spinous processes in a longitudinal orientation. An 80-mm echogenic needle will be advanced under in-plane ultrasound guidance in a cranial-to-caudal direction until the tip reaches the deep fascial plane of the erector spinae muscles at the level of the transverse process. Following negative aspiration and confirmation of correct needle placement by visualization of local anesthetic spread within the erector spinae plane, 20 mL of ropivacaine 2 mg/mL will be injected on each side. The procedure will then be repeated contralaterally, resulting in a total bilateral injection volume of 40 mL. Receives: Procedure: Single-level posterior lumbar arthrodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption within 48 hours after surgery, expressed in milligrams (mg), calculated as the cumulative consumption of intravenous (IV) morphine administered in the PACU and oral morphine converted to IV morphine equivalents.
Cumulative dose of intravenous morphine administered in the post-anesthesia care unit and oral oxycodone administered after discharge from the post-anesthesia care unit, converted into intravenous morphine equivalents. Unit in milligrams (mg).
Measured: From the end of surgery up to 48 hours postoperatively
Secondary outcomes (7)
Postoperative pain intensity assessed using the 0-10 Numerical Rating Scale (0-10 NRS)
Postoperative pain intensity, assessed using an 11-point Numerical Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain). Pain scores will be recorded by nursing staff blinded to treatment allocation following routine clinical practice. Pain intensity will be compared between the treatment groups.
Measured: At PACU discharge and at 12, 24, and 48 hours postoperatively.
Quality of postoperative recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire
Quality of postoperative recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire. The QoR-15 evaluates five dimensions of postoperative recovery: pain, physical comfort, physical independence, psychological support, and emotional state. The questionnaire consists of 15 items, each scored on an 11-point scale (rated from 0 to 10), with higher scores indicating better recovery. The total QoR-15 score is calculated by summing the scores of all items. Total QoR-15 score (range: 0-150, with higher scores indicating better postoperative recovery).
Measured: 72 hours postoperatively.
Time to first morphine administration
Time elapsed between arrival in the post-anesthesia care unit (PACU) and administration of the first dose of morphine for postoperative pain management.
Time in minutes (min).Participants who do not receive morphine within 48 hours will be censored at 48 hours.
Measured: From the end of surgery until the first morphine administration, up to 48 hours postoperatively.
Morphine consumption during stay in the post-anesthesia care unit (PACU)
Total amount of morphine administered during the stay in the post-anesthesia care unit (PACU) for postoperative pain management, expressed in milligrams (mg). Medication administration records.
Measured: From PACU admission until PACU discharge.
Duration of stay in the post-anesthesia care unit (PACU)
Time elapsed between PACU admission and PACU discharge in Minutes (min).
Measured: From PACU admission until PACU discharge.
Total duration of hospital stay
Time elapsed between hospital admission for surgery and hospital discharge in Days
Measured: From hospital admission until hospital discharge.(expected within approximately 3 days after surgery)
Incidence of treatment-related adverse events
Incidence of adverse events (AEs) and serious adverse events (SAEs) for which a causal relationship with the study analgesic treatment cannot be excluded, as assessed by the investigator.
Adverse event collection and clinical assessment recorded in the electronic case report form (eCRF), categorized by seriousness and severity.
Number and percentage of participants with at least one treatment-related adverse event.
Measured: From the start of study procedure to 72 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single-level Lumbar ArthrodesisStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895368
- Sponsor's protocol ID
- 2025-A02865-44 (LIBERA)
- Acronym
- LIBERA
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Analgesia Provided by Intravenous Lidocaine and Erector Spinae Plane Block Following Posterior Lumbar Arthrodesis
- ClinicalTrials.gov ID
- NCT07895368
- Acronym / sponsor ID
- LIBERA / 2025-A02865-44 (LIBERA)
- Conditions
- Single-level Lumbar Arthrodesis
- Keywords
- Posterior Lumbar Arthrodesis, Analgesic efficacy of intravenous lidocaine, Analgesic efficacy of erector spinae plane block, IV opioid consumption equivalent during the 48 postoperative hours
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 26 Oct 2026 (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.
The hypothesis of this study is that intraoperative intravenous lidocaine infusion provides postoperative analgesia and opioid-sparing effects that are at least equivalent to those achieved with a bilateral erector spinae plane block, while offering a simpler and faster procedure that does not require ultrasound guidance and whose efficacy is not dependent on operator expertise or on the uncertain spread of local anesthetic injection in the lumbar region.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 : Intraoperative Intravenous Lidocaine | Experimental | Procedure: Single-level posterior lumbar arthrodesisIn accordance with current consensus recommendations on the use of intravenous lidocaine, patients allocated to the lidocaine group will receive an intraoperative intravenous lidocaine infusion under general anesthesia. Administration will consist of a loading dose of 1.5 mg/kg delivered over 10 minutes, followed by a continuous infusion at a rate of 2.0 mg/kg/h using a syringe pump throughout the surgical procedure. The infusion will be stopped at the completion of surgery, defined as wound closure. |
| Erector Spinae Plane Block | Other | Procedure: Single-level posterior lumbar arthrodesisPatients allocated to the Erector Spinae Plane (ESP) block group will undergo a bilateral ultrasound-guided erector spinae plane block after induction of general anesthesia and placement in the prone position for surgery. The erector spinae muscles and lumbar transverse processes will be identified using ultrasound, with the probe positioned 2-3 cm lateral to the spinous processes in a longitudinal orientation. An 80-mm echogenic needle will be advanced under in-plane ultrasound guidance in a cranial-to-caudal direction until the tip reaches the deep fascial plane of the erector spinae muscles at the level of the transverse process. Following negative aspiration and confirmation of correct needle placement by visualization of local anesthetic spread within the erector spinae plane, 20 mL of ropivacaine 2 mg/mL will be injected on each side. The procedure will then be repeated contralaterally, resulting in a total bilateral injection volume of 40 mL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients aged ≥18 years.
- Patients who have read, understood, and signed the informed consent form prior to any study-specific procedure.
- Patients scheduled to undergo a single-level posterior lumbar fusion for lumbar spinal stenosis, degenerative spondylolisthesis, or unstable degenerative disc disease.
- Body weight between 50 and 120 kg.
- ASA physical status classification ≤ III.
Key exclusion criteria (12 listed)
- Emergency surgery.
- Reoperation of the surgical site.
- Contraindication to local anesthetics.
- Contraindication to NSAIDs.
- Coagulation disorder.
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 |
|---|---|---|
| Single-level posterior lumbar arthrodesisLumbar arthrodesis is a surgical procedure designed to achieve permanent fusion of one or more segments of the lumbar spine by immobilizing the corresponding intervertebral joints. | Procedure or surgery | Erector Spinae Plane Block, Group 1 : Intraoperative Intravenous Lidocaine |
Primary outcome
Total morphine consumption within 48 hours after surgery, expressed in milligrams (mg), calculated as the cumulative consumption of intravenous (IV) morphine administered in the PACU and oral morphine converted to IV morphine equivalents.
Time frame: From the end of surgery up to 48 hours postoperatively
Cumulative dose of intravenous morphine administered in the post-anesthesia care unit and oral oxycodone administered after discharge from the post-anesthesia care unit, converted into intravenous morphine equivalents. Unit in milligrams (mg).
7 secondary outcomes
Postoperative pain intensity assessed using the 0-10 Numerical Rating Scale (0-10 NRS)
Time frame: At PACU discharge and at 12, 24, and 48 hours postoperatively.
Quality of postoperative recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire
Time frame: 72 hours postoperatively.
Time to first morphine administration
Time frame: From the end of surgery until the first morphine administration, up to 48 hours postoperatively.
Morphine consumption during stay in the post-anesthesia care unit (PACU)
Time frame: From PACU admission until PACU discharge.
Duration of stay in the post-anesthesia care unit (PACU)
Time frame: From PACU admission until PACU discharge.
Total duration of hospital stay
Time frame: From hospital admission until hospital discharge.(expected within approximately 3 days after surgery)
Incidence of treatment-related adverse events
Time frame: From the start of study procedure to 72 hours after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Single-level Lumbar Arthrodesis
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Degenerative Lumbar Spinal Stenosis
Not yet recruitingPhase 4
Erector Spinae Plan Block (ESPB) with Dexmedetomidine and Dexamethasone in Lumbar Spine Fusion
Lumbar Degenerative Disease
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-level posterior lumbar arthrodesis in people with Single-level Lumbar Arthrodesis, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site 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 5 inclusion and 12 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: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume FANTIN, Dr (33 05 59 52 62 91, fantin.guillaume@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine consumption within 48 hours after surgery, expressed in milligrams (mg), calculated as the cumulative consumption of intravenous (IV) morphine administered in the PACU and oral morphine converted to IV morphine equivalents. (time frame: From the end of surgery up to 48 hours postoperatively). 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 26 Oct 2026.