Erectus Nerve Block for Lumbar Spine Surgery

NCT ID: NCT04473508

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-27
• Study Completion Date: 2021-09-09

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.

Conditions

Spine Surgery; Pain Relief; Morphine; AdverseEvent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treated

active treatment (Local anaesthetic): Local administration of ropivacaine 30 mL (5mg/mL)

Group Type: EXPERIMENTAL

Local administration of ropivacaine

Intervention Type: DRUG

Erector nerve block with local ropivacaine injection in addition with conventional anesthesia for spine surgery

Control

Local administration of Placebo ( Saline Solution)

Group Type: PLACEBO_COMPARATOR

Local administration of placebo (saline solution)

Intervention Type: DRUG

injection of saline solution in addition with conventional anesthesia for spine surgery

Interventions

Local administration of ropivacaine

Erector nerve block with local ropivacaine injection in addition with conventional anesthesia for spine surgery

Intervention Type: DRUG

Local administration of placebo (saline solution)

injection of saline solution in addition with conventional anesthesia for spine surgery

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Geoffrey Avis, Md

Role: PRINCIPAL_INVESTIGATOR

Geoffrey.avis@chu-nimes.fr

Locations

CHU Nimes

Nîmes, Gard, France

Countries

France

References

Avis G, Gricourt Y, Vialatte PB, Meunier V, Perin M, Simon N, Claret PG, El Fertit H, Lefrant JY, Bertrand M, Cuvillon P. Analgesic efficacy of erector spinae plane blocks for lumbar spine surgery: a randomized double-blind controlled clinical trial. Reg Anesth Pain Med. 2022 Jul 21:rapm-2022-103737. doi: 10.1136/rapm-2022-103737. Online ahead of print.

Reference Type: RESULT

PMID: 35863786 (View on PubMed)

Other Identifiers

2019-001678-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LOCAL/2018/PC-02

Identifier Type: -

Identifier Source: org_study_id