Erectus Nerve Block for Lumbar Spine Surgery

Phase 3

Completed

• Conditions: Pain Relief; AdverseEvent; Spine Surgery; Morphine
• Interventions: Drug: Local administration of ropivacaine; Drug: Local administration of placebo (saline solution)

• Registration Number: NCT04473508
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

: Spine surgery induced severe postoperative pain. Several techniques as intravenous multimodal analgesia have been proposed to reduce pain relief and morphine rescue over the first postoperative days. Regional anesthesia using the erectus nerve block is a simple infiltration across lamina of the vertebra: Ultrasound-guided posterior ramus of spinal nerve block for anesthesia and analgesia in lumbar spinal surgery This study compared erector nerve block with local anesthetic vs placebo to reduce pain and morphine rescue after lumbar spine surgery. The investigators hypothesized that eructor nerve block induced a large block from L1 to L5 that induced posterior nerve roots block anesthesia. This block reduced pain after surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-27
• Study First Submitted: 2020-01-27
• Study First Submitted QC: 2020-07-15
• Study First Posted: 2020-07-16
• Primary Completion: 2021-06-25
• Study Completion: 2021-09-09
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-15
• Last Update Posted: 2022-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• age> 18years and <80 years
• lumbar spine surgery (2-4 levels)
• posterior approach
• ASA 1-3

Exclusion Criteria

• refusal
• age < 18yrs
• <50 kg and >120 kg
• pregnant
• renal or hepatic severe desease
• ASA 4
• no French speaking
• emergency surgery
• local or systemic infection
• surgical resumption of the surgical site
• surgery involving a thoracic approach
• allergy to local anesthetics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treated	Local administration of ropivacaine	active treatment (Local anaesthetic): Local administration of ropivacaine 30 mL (5mg/mL)
Control	Local administration of placebo (saline solution)	Local administration of Placebo ( Saline Solution)

Primary Outcome Measures

Name	Time	Method
morphine consumption (mg)	24 Hours after surgery	Quantity administered in the post-interventional monitoring room and in hospitalization via a self-controlled morphine pump by the patient

Secondary Outcome Measures

Name	Time	Method
chronic pain: DN4 questionnaire	Questionnaire DN4 at 3 months	pain score as mesured with DN4 questionnaire
Length of hospital stay	hospital length of stay, an average of 4 days	Number of day in hospital
Length of stay in the post-intervention care unit	Day 1	Number of minutes that patient stay in post intervention care unit in minutes
pain at rest and at movement: Visual Analogic scale	Day 1 to Day 3, Day od hospital discharge and month 3	Visual Analogic scale of pain (0-10)
Patient Satisfaction: visual analogic scale	Day of hospital discharge, an average of day 4	Patient satisfaction mesured with a visual analogic scale (0-10)
Patient Quality of life: EQ-5D Questionnaire	3 months	Patient Quality of life mesured with EQ-5D Questionnaire
Adverse events	from surgery to 3 months	Nausea, vomiting, confusion, urinary retention, hematoma, reintervention

Trial Locations

Locations (1)

CHU Nimes; 🇫🇷 Nîmes, Gard, France