Transversus Abdominis Plane Block for Laparoscopic Appendicectomy in Children

NCT ID: NCT02505841

Last Updated: 2015-07-22

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

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-06-30

Brief Summary

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The transversus abdominis plane (TAP) block is a regional anesthetic technique for post operative pain control after abdominal surgical procedures. Its effectiveness in children undergoing laparoscopic appendectomy has not been demonstrated. The investigators evaluate its analgesic efficacy over the first 24 post operative hours.

Detailed Description

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Conditions

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Laparoscopic Appendectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Group 1

Curare: Atracurium injection at 0.5 mg/kg

Group Type ACTIVE_COMPARATOR

Curare

Intervention Type DRUG

Atracurium injection at 0.5 mg/kg at least 3 minutes before the surgical incision

Group 2

TAP block and curare: Ultrasound-guided transversus abdominis plane block wih Ropivacaine injection 0.2% at 0.3 ml/kg then atracurium injection at 0.5 mg/kg

Group Type EXPERIMENTAL

TAP block with Ropivacaine

Intervention Type OTHER

Ultrasound-guided transversus abdominis plane block wih Ropivacaine injection 0.2% at 0.3 ml/kg

Curare

Intervention Type DRUG

Atracurium injection at 0.5 mg/kg at least 3 minutes before the surgical incision

Group 3

TAP block: Ultrasound-guided transversus abdominis plane block wih Ropivacaine injection 0.2% at 0.3 ml/kg

Group Type EXPERIMENTAL

TAP block with Ropivacaine

Intervention Type OTHER

Ultrasound-guided transversus abdominis plane block wih Ropivacaine injection 0.2% at 0.3 ml/kg

Interventions

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TAP block with Ropivacaine

Ultrasound-guided transversus abdominis plane block wih Ropivacaine injection 0.2% at 0.3 ml/kg

Intervention Type OTHER

Curare

Atracurium injection at 0.5 mg/kg at least 3 minutes before the surgical incision

Intervention Type DRUG

Other Intervention Names

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Transversus abdominis plane (TAP) block with ropivacaine Succinylcholine

Eligibility Criteria

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Inclusion Criteria

* Patient hospitalized in surgery and infantile anesthesia unit or admitted in emergencies for an laparoscopic appendectomy surgery.
* Patient whose general state corresponds to the classification of the American Society of Anesthesiologists (ASA) I to II
* Patient member in a national insurance scheme

Exclusion Criteria

* Patient with drilled appendicitis or peritonitis
* Patient with a contraindication to local anesthesics
* Patient with a contraindication to TAP block
* Patient with allergies or known hypersensitivity to curare
Minimum Eligible Age

1 Year

Maximum Eligible Age

12 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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Maud MM Maniora, MD

Role: PRINCIPAL_INVESTIGATOR

Montpellier University Hospital

Locations

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CHRU Montpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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2014-A01431-46

Identifier Type: REGISTRY

Identifier Source: secondary_id

9488

Identifier Type: -

Identifier Source: org_study_id

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