Spine Surgery Clinical Trial
— EFABEOfficial title:
Erectus Nerve Block for Lumbar Spine Surgery : a Prospective Randomized Study
Verified date | March 2022 |
Source | Centre Hospitalier Universitaire de Nimes |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
: 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.
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 |
Country | Name | City | State |
---|---|---|---|
France | CHU Nimes | Nîmes | Gard |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nimes |
France,
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 |
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