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

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

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.

Study Overview

• Status: Unknown
• Conditions: Hydrocele; Inguinal or Ovarian Hernia; Cord Kyst; Local Analgesia Block; One to Five Years
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chrystelle CS SOLA, MD; Phone Number: +33 665849166; Email: c-sola@chu-montpellier.fr
• Study Contact Backup: Name: Sophie SB BRINGUIER-BRANCHEREAU, PhD; Phone Number: +33 467338661; Email: s-bringuierbranchereau@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34925
    • Recruiting
    • CHU Montpellier
    • Contact: Chrystelle CS SOLA, MD; Phone Number: +33 665849166; Email: c-sola@chu-montpellier.fr
    • Contact: Sophie SB BRINGUIER-BRANCHEREAU, PhD; Phone Number: +33 467338661; Email: s-bringuierbranchereau@chu-montpellier.fr
    • Principal Investigator: Chrystelle CS SOLA, MD
    • Sub-Investigator: Christophe CD DADURE, MD
    • Sub-Investigator: Olivier OR RAUX, MD
    • Sub-Investigator: Alain AR ROCHETTE, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 5 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative opioid consumption : total Rémifentanil (µg/kg)		for time of surgery (1 to 4 hours)
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)
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	cardiovascular adverse event, adverse vascular ponction (positive aspiration test for blood), adverse peritoneal ponction, hematoma	until 24 hours in post operative
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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Chrystelle CS SOLA, MD, CHU Montpellier - Lapeyronie hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (ANTICIPATED): November 1, 2015
• Study Completion (ANTICIPATED): November 1, 2015

Study Registration Dates

• First Submitted: February 4, 2014
• First Submitted That Met QC Criteria: February 13, 2014
• First Posted (ESTIMATE): February 17, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): February 17, 2014
• Last Update Submitted That Met QC Criteria: February 13, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: pharmacokinetics; Regional anesthesia; TAP block; Pediatric anesthesia; analgesic effects
• Additional Relevant MeSH Terms: Testicular Hydrocele; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Levobupivacaine
• Other Study ID Numbers: UF9206