Cord Kyst, Hydrocele, Inguinal or Ovarian Hernia, Local Analgesia Block, One to Five Years
Conditions
Keywords
Regional anesthesia, TAP block, Pediatric anesthesia, analgesic effects, pharmacokinetics
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.
Interventions
DRUGInjection 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
DRUGInjection 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
Sponsors
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
1 Years to 5 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Intraoperative opioid consumption : total Rémifentanil (µg/kg) | for time of surgery (1 to 4 hours) | — |
| 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 | — |
| 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 |
Countries
France
Contacts
Primary ContactChrystelle CS SOLA, MD
Backup ContactSophie SB BRINGUIER-BRANCHEREAU, PhD
Outcome results
None listed