Transversus Abdominis Plane Block for Laparoscopic Appendicectomy in Children

July 20, 2015 updated by: University Hospital, Montpellier

Transversus Abdominis Plane (TAP) Block for Laparoscopic Appendicectomy in Children: Opioid Saving and Alternative in the Curarization

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • CHRU Montpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
Curare: Atracurium injection at 0.5 mg/kg
Drug: Curare
Atracurium injection at 0.5 mg/kg at least 3 minutes before the surgical incision
Other Names:
  • Succinylcholine
Experimental: 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
Drug: Curare
Atracurium injection at 0.5 mg/kg at least 3 minutes before the surgical incision
Other Names:
  • Succinylcholine
Other: TAP block with Ropivacaine
Ultrasound-guided transversus abdominis plane block wih Ropivacaine injection 0.2% at 0.3 ml/kg
Other Names:
  • Transversus abdominis plane (TAP) block with ropivacaine
Experimental: Group 3
TAP block: Ultrasound-guided transversus abdominis plane block wih Ropivacaine injection 0.2% at 0.3 ml/kg
Other: TAP block with Ropivacaine
Ultrasound-guided transversus abdominis plane block wih Ropivacaine injection 0.2% at 0.3 ml/kg
Other Names:
  • Transversus abdominis plane (TAP) block with ropivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Painkiller of help consumption
Time Frame: up to 24 hours after surgery
Quantity of analgesic of help (Nalbuphine, Nubain®, Dupont Pharma, Paris, France) taken after the surgery.
up to 24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity after surgery
Time Frame: up to 24 hours
The post-operative pain will be estimated from the arrival in recovery room with the Face Legs Activity Cry Consolability (FLACC) scale.
up to 24 hours
First demand of analgesic of help
Time Frame: up to 12 hours
First demand of analgesic of help (Nubain ®) after the surgery
up to 12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Maud MM Maniora, MD, Montpellier University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

May 1, 2015

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

June 22, 2015

First Submitted That Met QC Criteria

July 20, 2015

First Posted (Estimate)

July 22, 2015

Study Record Updates

Last Update Posted (Estimate)

July 22, 2015

Last Update Submitted That Met QC Criteria

July 20, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9488
  • 2014-A01431-46 (Registry Identifier: ID RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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