Transversus Abdominis Plane Block in Pediatrics: Volume or Concentration ?

NCT02064088 | Unknown

• 1 other identifier: UF9206
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Intraoperative opioid consumption : total Rémifentanil (µg/kg)

  for time of surgery (1 to 4 hours)

• Post operative pain (FLACC scale) at hospital

  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

  until 24 hours in post operative

Study Arms (2)

Small volume

EXPERIMENTAL

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

High volume

EXPERIMENTAL

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

Interventions

Injection of 0,2 ml/kg of 0,2% levobupivacaine for small volume group DRUG

Ultrasound guided administration of 0,2 ml/kg of 0,2% lévobupivacaine in the plane between the internal oblique and transversus abdominis muscles

Small volume

Injection of 0,4 ml/kg of 0,1% lévobupivacaine for high volume group DRUG

Ultrasound guided administration of 0,4 ml/kg of 0,1% lévobupivacaine in the plane between the internal oblique and transversus abdominis muscles

High volume

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Coagulation trouble
• Infection on ponction zone
• Local anesthesia drug or nonsteroidal anti inflammatory intolerance
• Cardiac/Renal/hepacticdysfunction
• Hemorrage, digestive perforation history

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU Montpellier

Montpellier, 34925, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 31094793 DERIVED

MeSH Terms

Conditions

Testicular Hydrocele

Condition Hierarchy (Ancestors)

Testicular Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Chrystelle CS SOLA, MD

  CHU Montpellier - Lapeyronie Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chrystelle CS SOLA, MD

CONTACT

+33 665849166; c-sola@chu-montpellier.fr

Sophie SB BRINGUIER-BRANCHEREAU, PhD

CONTACT

+33 467338661; s-bringuierbranchereau@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2014
• First Posted: February 17, 2014
• Study Start: November 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 17, 2014

Record last verified: 2014-02

Locations

FR (1)