Transversus Abdominis Plane Block in Pediatrics: Volume or Concentration ?

Study Overview
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Brief Summary
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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.

Official Title
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Volume or Concentration for the Transverse Abdominal Plane Block in Children Aged 1-5 Years: Analgesic Effects and Safety

Conditions
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Inguinal or Ovarian Hernia, Hydrocele, Cord Kyst, Local Analgesia Block, One to Five Years

Intervention / Treatment
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* Drug: Injection of 0,2 ml/kg of 0,2% levobupivacaine for small volume group
* Drug: Injection of 0,4 ml/kg of 0,1% lévobupivacaine for high volume group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalisation in ambulatory surgery and anesthesia unit for surgery of inguinal hernia or ovarian hernia or hydrocele or cord kyst Overall status: ASA I-II Aged from 1 to 5 years Informed consent Exclusion Criteria: Coagulation trouble Infection on ponction zone Local anesthesia drug or nonsteroidal anti inflammatory intolerance Cardiac/Renal/hepacticdysfunction Hemorrage, digestive perforation history

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Small volume<br>Local analgesia by one injection of 0,2 ml/kg of 0,2% lévobupivacaine | Drug: Injection of 0,2 ml/kg of 0,2% levobupivacaine for small volume group<br>* Ultrasound guided administration of 0,2 ml/kg of 0,2% lévobupivacaine in the plane between the internal oblique and transversus abdominis muscles<br>|
| Experimental: High volume<br>Local analgesia by one injection of 0,4 ml/kg of 0,1% lévobupivacaine | Drug: Injection of 0,4 ml/kg of 0,1% lévobupivacaine for high volume group<br>* Ultrasound guided administration of 0,4 ml/kg of 0,1% lévobupivacaine in the plane between the internal oblique and transversus abdominis muscles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Regional anesthesia, TAP block, Pediatric anesthesia, analgesic effects, pharmacokinetics