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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001678-26 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated | Experimental | active treatment (Local anaesthetic): Local administration of ropivacaine 30 mL (5mg/mL) |
|
| Control | Placebo Comparator | Local administration of Placebo ( Saline Solution) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Local administration of ropivacaine | Drug | Erector nerve block with local ropivacaine injection in addition with conventional anesthesia for spine surgery |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geoffrey Avis, Md | Geoffrey.avis@chu-nimes.fr | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Nimes | Nîmes | Gard | 30 000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35863786 | Result | 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. |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Local administration of placebo (saline solution) | Drug | injection of saline solution in addition with conventional anesthesia for spine surgery |
|
| 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 |