Erectus Nerve Block for Lumbar Spine Surgery

Spine Surgery Clinical Trial

— EFABE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04473508
• Other study ID #: LOCAL/2018/PC-02
• Status: Completed
• Phase: Phase 3
• Start date: November 27, 2019
• Est. completion date: September 9, 2021

Study information

• Verified date: March 2022
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 9, 2021
• Est. primary completion date: June 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• AdverseEvent
• Morphine
• Pain Relief
• Spine Surgery

Intervention

Drug:
• Local administration of ropivacaine
Erector nerve block with local ropivacaine injection in addition with conventional anesthesia for spine surgery
• Local administration of placebo (saline solution)
injection of saline solution in addition with conventional anesthesia for spine surgery

Locations

Country	Name	City	State
France	CHU Nimes	Nîmes	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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