Erectus Nerve Block for Lumbar Spine Surgery

Study Overview
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Brief Summary
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: 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.

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

Conditions
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Spine Surgery, Pain Relief, Morphine, AdverseEvent

Intervention / Treatment
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* Drug: Local administration of ropivacaine
* Drug: Local administration of placebo (saline solution)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 |