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Therapeutic, prospective, randomized, double blind, placebo-controlled, in intention to treat, monocentric study to evaluate the analgesic efficacy of a bilateral TAP block after spine surgery with 24 hours morphine consumption
ALIF is a commonly performed procedure for the treatment of degenerative diseases of the lumbar spine or spondylolisthesis. This technique has many advantages attributed to the absence of posterior spinal muscular pain, a more direct visualization of the disk space, lower incidence of neurological injuries… However, patients experienced moderate to high post operative parietal abdominal pain due to this specific anterior approach. The systematic need for opioids administration may cause many complications and delay the post operative recovery time. The TAP block has been described as an effective pain control technique after various lower abdominal surgeries, reducing both pain scores and 24 hours opioids consumption. However the analgesic efficacy of this technique on specific parietal abdominal pain experienced after spine surgery by anterior approach is not clear
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAP block ropivacaine | Experimental | Bilateral ultrasound guided with 15 ml ropivacaine 5mg/ml on each side under general anesthesia at the end of the intervention |
|
| TAP block placebo | Placebo Comparator | Bilateral ultrasound guided with 15 ml saline on each side under general anesthesia at the end of the intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAP block ropivacaine | Drug |
| ||
| TAP block placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine consumption in the first 24 hours after spine surgery by anterior approach | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine consumption in the first 48 hours after spine surgery by anterior approach | 48 hours | |
| Assessment of pain | Numerical Analogue score | 1, 6, 12, 24 and 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Rennes | Rennes | 35033 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37031893 | Result | Coquet A, Sion A, Bourgoin A, Ropars M, Beloeil H. Transversus abdominis plane block for anterior lumbar interbody fusion: a randomized controlled trial. Spine J. 2023 Aug;23(8):1137-1143. doi: 10.1016/j.spinee.2023.03.013. Epub 2023 Apr 7. |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D013168 | Spondylolisthesis |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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|
| General anesthesia | Drug | Induction PROPOFOL 10mg/ml REMIFENTANIL 50 μg/ml CISATRACURIUM 2mg/ml if necessary DEXAMETHASONE 8 mg KETAMINE 0,15mg/kg Maintenance PROPOFOL 10mg/ml REMIFENTANIL 50 μg/ml |
|
| Assessment of post operative nausea or vomiting | Occurence of nausea or vomiting episodes over 48 hours | 48 hours |
| Delay before first morphine administration | Number of hours between end of surgery and first morphine administration | Day 1 |
| Delay before the first lift | Number of hours between end of surgery and the first lift | Day 1 |
| Delay before resumption of transit | Number of days between end of surgery and resumption of transit | Day 1 |
| Duration of hospitalization | Day 1 |
| Patient satisfaction | Satisfaction questionnaire | 48 hours |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013169 | Spondylolysis |
| D055009 | Spondylosis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |