Evaluation of the postoperative analgesic efficacy of erector spinae plane block in lumbar spinal surgery: a prospective randomized double-blind study

Phase 1

Recruiting

Conditions: Patients undergoing lumbar arthrodesis
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: CTIS2023-504204-28-00

Lead Sponsor: CHU De Liege

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 126

Inclusion Criteria

All genders aged from 18 to 85 years old, ASA 1 or 2, Scheduled for lumbar arthrodesis surgery 1 to 3 levels

Exclusion Criteria

A BMI <18 or > 35 or weight < 50kg, Kidney or liver failure, Uncontrolled hypertension at home or requiring more than 2 anti-hypertensive treatments, Minimally invasive surgery with unilateral approach, percutaneous or without laminectomy, Allergy to one or more of the medications used in the study, Chronic pain (chronic medication and/or presence of a neurostimulator), fibromyalgia, psychiatric disorders, alcoholism and/or chronic use of strong opioids (considered chronic if taking a strong opioid on a daily basis for > 1 week) preoperatively, A contraindication to a loco-regional anesthesia technique, Refusal of consent by the patient

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Post-operative morphine consumption after lumbar arthrodesis with and without erector spinae plane block;Secondary Objective: Secondary objectives will allow to evaluate complications due to the block and quality of recovery after surgery;Primary end point(s): The primary objective will define wether or not ESPB is effective at reducing opioid consumption, in morphine oral equivalent, during the first 24 hours postoperatively

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Analysis of intraoperative parameters (blood pressure, heart rate, Response and State Entropy (RE/SE), Surgical Plethysmographic Index (SPI) at the time of the block, during incision and at extubation.;Secondary end point(s):Absence of complications related to the block;Secondary end point(s):Opioid use in the PACU;Secondary end point(s):Level of drowsiness in PACU (RASS score);Secondary end point(s):Pain scores at different time intervals from PACU to hospital discharge;Secondary end point(s):Length of hospitalization;Secondary end point(s):Assessment of the quality of postoperative recovery using the QoR-15 score at PCA withdrawal;Secondary end point(s):Presence of PONV, constipation, pruritus