Clinical trial NCT02064088: Transversus Abdominis Plane Block in Pediatrics: Volume or Concentration ?
Official title: Volume or Concentration for the Transverse Abdominal Plane Block in Children Aged 1-5 Years: Analgesic Effects and Safety
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inguinal or Ovarian Hernia
Hydrocele
Cord Kyst
Local Analgesia Block
One to Five Years
Keywords: Regional anesthesia
TAP block
Pediatric anesthesia
analgesic effects
pharmacokinetics
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2014-02-17
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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

Primary outcomes:
measure: number of patients for whom a rescue analgesia was necessary in post anesthesia care unit and ambulatory surgery unit
timeFrame: from arrival in post anesthesia care unit until discharge (An expected average of 4 hours after end of surgery)
Secondary outcomes:
measure: Intraoperative opioid consumption : total Rémifentanil (µg/kg)
timeFrame: for time of surgery (1 to 4 hours)
measure: Post operative pain (FLACC scale) at hospital
timeFrame: from recovery room until discharge (An expected average of 4 hours after end of surgery)
measure: Plasmatique peak of levobupivacaine (Cmax in µg/ml)
timeFrame: 5 min until 75 min after injection of local anaesthetic
measure: Time necessary to reach plasmatique peak of levobupivacaine (tmax in min)
timeFrame: 5 min until 75 min after injection of local anaesthetic
measure: Complications related to local analgesia procedure
timeFrame: until 24 hours in post operative
measure: First request of rescue antalgic (Nubain or Tramadol)
timeFrame: until 24 hours in post operative
measure: Consommation of rescue antalgic
timeFrame: until 24 hours in post operative
measure: Pain evaluation at home by parents (score PPMP)
timeFrame: call between 24 and 48 hours in post operative
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU Montpellier
Study officials:
affiliation: CHU Montpellier - Lapeyronie Hospital
name: Chrystelle CS SOLA, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sola C, Menace C, Bringuier S, Saour AC, Raux O, Mathieu O, Capdevila X, Dadure C. Transversus Abdominal Plane Block in Children: Efficacy and Safety: A Randomized Clinical Study and Pharmacokinetic Profile. Anesth Analg. 2019 Jun;128(6):1234-1241. doi: 10.1213/ANE.0000000000003736.