Transversus Abdominis Plane Block in Pediatrics: Volume or Concentration ?
- Conditions
- Inguinal or Ovarian HerniaOne to Five YearsHydroceleCord KystLocal Analgesia Block
- Interventions
- Drug: Injection of 0,4 ml/kg of 0,1% lévobupivacaine for high volume group
- Registration Number
- NCT02064088
- Lead Sponsor
- University Hospital, Montpellier
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 70
- 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
- Coagulation trouble
- Infection on ponction zone
- Local anesthesia drug or nonsteroidal anti inflammatory intolerance
- Cardiac/Renal/hepacticdysfunction
- Hemorrage, digestive perforation history
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Small volume Injection of 0,2 ml/kg of 0,2% levobupivacaine for small volume group Local analgesia by one injection of 0,2 ml/kg of 0,2% lévobupivacaine High volume Injection of 0,4 ml/kg of 0,1% lévobupivacaine for high volume group Local analgesia by one injection of 0,4 ml/kg of 0,1% lévobupivacaine
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Intraoperative opioid consumption : total Rémifentanil (µg/kg) for time of surgery (1 to 4 hours) 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
Trial Locations
- Locations (1)
CHU Montpellier
🇫🇷Montpellier, France