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The transversus abdominis plane (TAP) block provide a local anesthesia drug diffusion between the transverse abdominis muscle and the internal oblique muscle. TAP block reaches the anterior rami of spinal nerves from T7 to L1 involved in the innervation of homolateral abdominal wall. The transversus abdominis plane block has shown promise for perioperative analgesia, but data on the optimal dose regimen are limited.Following previous research of optimal dose of local anesthesic solution, the investigators aim to evaluate if a "volume effect" would lead to a better diffusion of the local anesthesic solution to the overall nervous roots. The local anesthesia drug choosen is levobupivacaine with a unique posology of 0,4 mg/kg (either 0,2 ml/kg of 0,2% levobupivacaine for "small volume" group or 0,4 ml/kg of 0,1% levobupivacaine for "high volume" group).With the same dose of levobupivacaine, this study aims to assess the impact of volume effect on analgesia efficiency as well as the security as after ultrasound TAP block on one to five years' old children who undergo a peritoneal-vaginal duct surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Small volume | Experimental | Local analgesia by one injection of 0,2 ml/kg of 0,2% lévobupivacaine |
|
| High volume | Experimental | Local analgesia by one injection of 0,4 ml/kg of 0,1% lévobupivacaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injection of 0,2 ml/kg of 0,2% levobupivacaine for small volume group | Drug | Ultrasound guided administration of 0,2 ml/kg of 0,2% lévobupivacaine in the plane between the internal oblique and transversus abdominis muscles |
| Measure | Description | Time Frame |
|---|---|---|
| number of patients for whom a rescue analgesia was necessary in post anesthesia care unit and ambulatory surgery unit | from arrival in post anesthesia care unit until discharge (An expected average of 4 hours after end of surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative opioid consumption : total Rémifentanil (µg/kg) | for time of surgery (1 to 4 hours) | |
| Post operative pain (FLACC scale) at hospital | Post operative pain is evaluated every 15 minutes in the recovery room and then every two hours in the ambulatory surgical unit until discharge at home. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chrystelle CS SOLA, MD | Contact | +33 665849166 | c-sola@chu-montpellier.fr | |
| Sophie SB BRINGUIER-BRANCHEREAU, PhD | Contact | +33 467338661 | s-bringuierbranchereau@chu-montpellier.fr |
| Name | Affiliation | Role |
|---|---|---|
| Chrystelle CS SOLA, MD | CHU Montpellier - Lapeyronie Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Montpellier | Recruiting | Montpellier | 34925 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31094793 | Derived | Sola C, Menace C, Bringuier S, Saour AC, Raux O, Mathieu O, Capdevila X, Dadure C. Transversus Abdominal Plane Block in Children: Efficacy and Safety: A Randomized Clinical Study and Pharmacokinetic Profile. Anesth Analg. 2019 Jun;128(6):1234-1241. doi: 10.1213/ANE.0000000000003736. |
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| Injection of 0,4 ml/kg of 0,1% lévobupivacaine for high volume group | Drug | Ultrasound guided administration of 0,4 ml/kg of 0,1% lévobupivacaine in the plane between the internal oblique and transversus abdominis muscles |
|
| from recovery room until discharge (An expected average of 4 hours after end of surgery) |
| Plasmatique peak of levobupivacaine (Cmax in µg/ml) | 5 min until 75 min after injection of local anaesthetic |
| Time necessary to reach plasmatique peak of levobupivacaine (tmax in min) | 5 min until 75 min after injection of local anaesthetic |
| Complications related to local analgesia procedure | cardiovascular adverse event, adverse vascular ponction (positive aspiration test for blood), adverse peritoneal ponction, hematoma | until 24 hours in post operative |
| First request of rescue antalgic (Nubain or Tramadol) | until 24 hours in post operative |
| Consommation of rescue antalgic | until 24 hours in post operative |
| Pain evaluation at home by parents (score PPMP) | call between 24 and 48 hours in post operative |
| ID | Term |
|---|---|
| D006848 | Testicular Hydrocele |
| ID | Term |
|---|---|
| D013733 | Testicular Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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