Transversus Abdominis Plane Block in Pediatrics: Volume or Concentration ? (TAP Bloc)

University Hospital Center (CHU)

Status: Unknown

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

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT02064088

UF9206

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 1 to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

70 participants in 2 patient groups

Small volume

Experimental group

Description:

Local analgesia by one injection of 0,2 ml/kg of 0,2% lévobupivacaine

Treatment:

Drug: Injection of 0,2 ml/kg of 0,2% levobupivacaine for small volume group

High volume

Experimental group

Description:

Local analgesia by one injection of 0,4 ml/kg of 0,1% lévobupivacaine

Treatment:

Drug: Injection of 0,4 ml/kg of 0,1% lévobupivacaine for high volume group