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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02064088
Other study ID # UF9206
Secondary ID
Status Recruiting
Phase N/A
First received February 4, 2014
Last updated February 13, 2014
Start date November 2013
Est. completion date November 2015

Study information

Verified date February 2014
Source University Hospital, Montpellier
Contact Chrystelle CS SOLA, MD
Phone +33 665849166
Email c-sola@chu-montpellier.fr
Is FDA regulated No
Health authority France: Committee for the Protection of Personnes
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 5 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)


Intervention

Drug:
Injection of 0,2 ml/kg of 0,2% levobupivacaine for small volume group
Ultrasound guided administration of 0,2 ml/kg of 0,2% lévobupivacaine in the plane between the internal oblique and transversus abdominis muscles
Injection of 0,4 ml/kg of 0,1% lévobupivacaine for high volume group
Ultrasound guided administration of 0,4 ml/kg of 0,1% lévobupivacaine in the plane between the internal oblique and transversus abdominis muscles

Locations

Country Name City State
France CHU Montpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) No
Secondary Intraoperative opioid consumption : total Rémifentanil (µg/kg) for time of surgery (1 to 4 hours) No
Secondary 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) No
Secondary Plasmatique peak of levobupivacaine (Cmax in µg/ml) 5 min until 75 min after injection of local anaesthetic Yes
Secondary Time necessary to reach plasmatique peak of levobupivacaine (tmax in min) 5 min until 75 min after injection of local anaesthetic Yes
Secondary 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 Yes
Secondary First request of rescue antalgic (Nubain or Tramadol) until 24 hours in post operative No
Secondary Consommation of rescue antalgic until 24 hours in post operative No
Secondary Pain evaluation at home by parents (score PPMP) call between 24 and 48 hours in post operative No
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