Erectus Nerve Block for Lumbar Spine Surgery (EFABE)

Centre Hospitalier Universitaire de Nīmes

Status and phase: Completed; Phase 3

Conditions: Morphine; Spine Surgery; AdverseEvent; Pain Relief

Treatments: Drug: Local administration of ropivacaine; Drug: Local administration of placebo (saline solution)

Study type: Interventional

Funder types: Other

Identifiers

NCT04473508

LOCAL/2018/PC-02

2019-001678-26 (EudraCT Number)

Details and patient eligibility

About

: 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Treated

Experimental group

Description:

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

Treatment:

Drug: Local administration of ropivacaine

Control

Placebo Comparator group

Description:

Local administration of Placebo ( Saline Solution)

Treatment:

Drug: Local administration of placebo (saline solution)