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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019662-88 | EudraCT Number |
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The study has been halted prematurely beacuse of the occurence of convulsions in one case after TAP block.
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Women undergoing elective cesarean delivery, performed under a standard spinal anesthesia, will be randomized to undergo either TAP block or incisional infiltration with local anesthetic, in addition to standard postoperative analgesia comprising regular acetaminophen, nefopam and ketoprofen. Short acting oral morphine will be given as a rescue treatment in case of severe pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transversus Abdominis Plane (TAP) Block | Experimental | Patients will receive a bilateral transversus abdominis plane block |
|
| Incisional Infiltration of Local Anesthetic | Active Comparator | Patients will receive an incisional infiltration with local anesthetic (continuous administration of levobupivacaïne during 48 hours) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transversus Abdominis Plane (TAP) Block | Other | Bilateral injection of levobupivacaine (20 mL, 3.75 mg/mL) |
|
| Measure | Description | Time Frame |
|---|---|---|
| severity of postoperative pain | 48 postoperative hours |
| Measure | Description | Time Frame |
|---|---|---|
| delay before the first rescue dose of morphine | 48 postoperative hours | |
| morphine requirement | 48 postoperative hours | |
| complication of each loco-regional technique |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Fischler, MD | Hôpital Foch | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Foch | Suresnes | 92150 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25093663 | Derived | Chandon M, Bonnet A, Burg Y, Barnichon C, DesMesnards-Smaja V, Sitbon B, Foiret C, Dreyfus JF, Rahmani J, Laloe PA, Fischler M, Le Guen M. Ultrasound-guided Transversus Abdominis plane block versus continuous wound infusion for post-caesarean analgesia: a randomized trial. PLoS One. 2014 Aug 5;9(8):e103971. doi: 10.1371/journal.pone.0103971. eCollection 2014. |
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| ID | Term |
|---|---|
| D003766 | Dental Occlusion |
| ID | Term |
|---|---|
| D003813 | Dentistry |
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
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| Incisional Infiltration of Local Anesthetic | Other | continuous administration of levobupivacaine (1,25 mg/mL,5 mL/h) during 48 hours. |
|
| end of hospitalisation |
| patient's satisfaction | end of hospitalisation |
| length of hospital stay | end of hospitalisation |
| occurrence of a neuropathic postoperative pain | 1 month postoperatively |