Erectus Nerve Block for Lumbar Spine Surgery : a Prospective Randomized Study
Overview
- Phase
- Phase 3
- Intervention
- Local administration of ropivacaine
- Conditions
- Spine Surgery
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- morphine consumption (mg)
- Status
- Completed
- Last Updated
- 4 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •age\> 18years and \<80 years
- •lumbar spine surgery (2-4 levels)
- •posterior approach
Exclusion Criteria
- •age \< 18yrs
- •\<50 kg and \>120 kg
- •renal or hepatic severe desease
- •no French speaking
- •emergency surgery
- •local or systemic infection
- •surgical resumption of the surgical site
- •surgery involving a thoracic approach
- •allergy to local anesthetics
Arms & Interventions
Treated
active treatment (Local anaesthetic): Local administration of ropivacaine 30 mL (5mg/mL)
Intervention: Local administration of ropivacaine
Control
Local administration of Placebo ( Saline Solution)
Intervention: Local administration of placebo (saline solution)
Outcomes
Primary Outcomes
morphine consumption (mg)
Time Frame: 24 Hours after surgery
Quantity administered in the post-interventional monitoring room and in hospitalization via a self-controlled morphine pump by the patient
Secondary Outcomes
- chronic pain: DN4 questionnaire(Questionnaire DN4 at 3 months)
- Length of hospital stay(hospital length of stay, an average of 4 days)
- Length of stay in the post-intervention care unit(Day 1)
- pain at rest and at movement: Visual Analogic scale(Day 1 to Day 3, Day od hospital discharge and month 3)
- Patient Satisfaction: visual analogic scale(Day of hospital discharge, an average of day 4)
- Adverse events(from surgery to 3 months)
- Patient Quality of life: EQ-5D Questionnaire(3 months)