Transversus Abdominis Plane Block in Pediatrics: Volume or Concentration ?

Hydrocele Clinical Trial

— TAP Bloc  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02064088
• Other study ID #: UF9206
• 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)

Related Conditions & MeSH terms

• Cord Kyst
• Hydrocele
• Inguinal or Ovarian Hernia
• Local Analgesia Block
• One to Five Years

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