Intravenous Lidocaine Versus Erector Spinae Plane Block After Lumbar Arthrodesis (LIBERA)

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

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche is the lead sponsor of 206 studies on the registry; 98 are open to participants now.

Study arms

• Experimental
  Group 1 : Intraoperative Intravenous Lidocaine

  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.

  Procedure: Single-level posterior lumbar arthrodesis

• Other
  Erector Spinae Plane Block

  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.

  Procedure: Single-level posterior lumbar arthrodesis

Interventions

• ProcedureSingle-level posterior lumbar arthrodesis

  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.

Primary outcomes

1. 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).

   Time frame: From the end of surgery up to 48 hours postoperatively

Secondary outcomes

1. 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.

   Time frame: At PACU discharge and at 12, 24, and 48 hours postoperatively.

2. 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).

   Time frame: 72 hours postoperatively.

3. 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.

   Time frame: From the end of surgery until the first morphine administration, up to 48 hours postoperatively.

4. 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.

   Time frame: From PACU admission until PACU discharge.

5. Duration of stay in the post-anesthesia care unit (PACU)

   Time elapsed between PACU admission and PACU discharge in Minutes (min).

   Time frame: From PACU admission until PACU discharge.

6. Total duration of hospital stay

   Time elapsed between hospital admission for surgery and hospital discharge in Days

   Time frame: From hospital admission until hospital discharge.(expected within approximately 3 days after surgery)

7. 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.

   Time frame: From the start of study procedure to 72 hours after surgery.

Individual participant data

Plan to share: Undecided