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UnknownNCT02064088

Transversus Abdominis Plane Block in Pediatrics: Volume or Concentration ?

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
70 (estimated)
Sponsor
University Hospital, Montpellier · Academic / Other
Sex
All
Age
1 Year – 5 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DRUGInjection of 0,2 ml/kg of 0,2% levobupivacaine for small volume groupUltrasound guided administration of 0,2 ml/kg of 0,2% lévobupivacaine in the plane between the internal oblique and transversus abdominis muscles
DRUGInjection of 0,4 ml/kg of 0,1% lévobupivacaine for high volume groupUltrasound guided administration of 0,4 ml/kg of 0,1% lévobupivacaine in the plane between the internal oblique and transversus abdominis muscles

Timeline

Start date
2013-11-01
Primary completion
2015-11-01
Completion
2015-11-01
First posted
2014-02-17
Last updated
2014-02-17

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT02064088. Inclusion in this directory is not an endorsement.