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

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Unknown status

CT.gov ID

NCT02064088

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Inguinal or Ovarian Hernia Hydrocele Cord Kyst Local Analgesia Block One to Five Years	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	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Official Title:

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

Study Start Date :

Nov 1, 2013

Anticipated Primary Completion Date :

Nov 1, 2015

Anticipated Study Completion Date :

Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Small volume 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 Ultrasound guided administration of 0,2 ml/kg of 0,2% lévobupivacaine in the plane between the internal oblique and transversus abdominis muscles
Experimental: High volume 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 Ultrasound guided administration of 0,4 ml/kg of 0,1% lévobupivacaine in the plane between the internal oblique and transversus abdominis muscles

Arm

Intervention/Treatment

Experimental: Small volume

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

Ultrasound guided administration of 0,2 ml/kg of 0,2% lévobupivacaine in the plane between the internal oblique and transversus abdominis muscles

Experimental: High volume

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

Ultrasound guided administration of 0,4 ml/kg of 0,1% lévobupivacaine in the plane between the internal oblique and transversus abdominis muscles

Outcome Measures

Primary Outcome Measures

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

Intraoperative opioid consumption : total Rémifentanil (µg/kg) [for time of surgery (1 to 4 hours)]
Post operative pain (FLACC scale) at hospital [from recovery room until discharge (An expected average of 4 hours after end of surgery)]
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.
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 [until 24 hours in post operative]
cardiovascular adverse event, adverse vascular ponction (positive aspiration test for blood), adverse peritoneal ponction, hematoma
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 5 Years

Sexes Eligible for Study:

All

Accepts 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