Erectus Nerve Block for Lumbar Spine Surgery (EFABE)

Erectus Nerve Block for Lumbar Spine Surgery : a Prospective Randomized Study

: 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.

Study Overview

• Status: Completed
• Conditions: Spine Surgery; Pain Relief; Morphine; AdverseEvent
• Intervention / Treatment: Drug: Local administration of ropivacaine; Drug: Local administration of placebo (saline solution)

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Gard
    • Nîmes, Gard, France, 30 000
      • CHU Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treated; active treatment (Local anaesthetic): Local administration of ropivacaine 30 mL (5mg/mL)	Drug: Local administration of ropivacaine; Erector nerve block with local ropivacaine injection in addition with conventional anesthesia for spine surgery
Placebo Comparator: Control; Local administration of Placebo ( Saline Solution)	Drug: Local administration of placebo (saline solution); injection of saline solution in addition with conventional anesthesia for spine surgery

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Geoffrey Avis, Md, Geoffrey.avis@chu-nimes.fr

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2019
• Primary Completion (Actual): June 25, 2021
• Study Completion (Actual): September 9, 2021

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: July 15, 2020
• First Posted (Actual): July 16, 2020

Study Record Updates

• Last Update Posted (Actual): March 16, 2022
• Last Update Submitted That Met QC Criteria: March 15, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: LOCAL/2018/PC-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No