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Transversus Abdominis Plane Block for Laparoscopic Appendicectomy in Children

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ClinicalTrials.gov Identifier: NCT02505841
Recruitment Status : Unknown
Verified May 2015 by University Hospital, Montpellier.
Recruitment status was:  Active, not recruiting
First Posted : July 22, 2015
Last Update Posted : July 22, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Laparoscopic Appendectomy Other: TAP block with Ropivacaine Drug: Curare Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Transversus Abdominis Plane (TAP) Block for Laparoscopic Appendicectomy in Children: Opioid Saving and Alternative in the Curarization
Study Start Date : May 2015
Actual Primary Completion Date : May 2015
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


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 Name: 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
Other: TAP block with Ropivacaine
Ultrasound-guided transversus abdominis plane block wih Ropivacaine injection 0.2% at 0.3 ml/kg
Other Name: Transversus abdominis plane (TAP) block with ropivacaine

Drug: Curare
Atracurium injection at 0.5 mg/kg at least 3 minutes before the surgical incision
Other Name: Succinylcholine

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 Name: Transversus abdominis plane (TAP) block with ropivacaine




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. First demand of analgesic of help [ Time Frame: up to 12 hours ]
    First demand of analgesic of help (Nubain ®) after the surgery



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Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02505841


Locations
France
CHRU Montpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Maud MM Maniora, MD Montpellier University Hospital

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02505841     History of Changes
Other Study ID Numbers: 9488
2014-A01431-46 ( Registry Identifier: ID RCB )
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: July 22, 2015
Last Verified: May 2015

Keywords provided by University Hospital, Montpellier:
Appendectomy
Laparoscopy
pediatric surgery

Additional relevant MeSH terms:
Ropivacaine
Succinylcholine
Atracurium
Curare
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Neuromuscular Depolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Neuromuscular Nondepolarizing Agents
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action