Transversus Abdominis Plane Block in Pediatrics: Volume or Concentration ?

NCT ID: NCT02064088

Last Updated: 2014-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-11-30

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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Small volume

Local analgesia by one injection of 0,2 ml/kg of 0,2% lévobupivacaine

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

High volume

Local analgesia by one injection of 0,4 ml/kg of 0,1% lévobupivacaine

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chrystelle CS SOLA, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Montpellier - Lapeyronie Hospital

Locations

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CHU Montpellier

Montpellier, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Chrystelle CS SOLA, MD

Role: CONTACT

+33 665849166

Sophie SB BRINGUIER-BRANCHEREAU, PhD

Role: CONTACT

+33 467338661

Facility Contacts

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Chrystelle CS SOLA, MD

Role: primary

+33 665849166

Sophie SB BRINGUIER-BRANCHEREAU, PhD

Role: backup

+33 467338661

References

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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.

Reference Type DERIVED
PMID: 31094793 (View on PubMed)

Other Identifiers

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UF9206

Identifier Type: -

Identifier Source: org_study_id

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