Transversus Abdominis Plane Block for Laparoscopic Appendicectomy in Children

NCT02505841 | Unknown

• 2 other identifiers: 94882014-A01431-46
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Appendectomy

Keywords

Appendectomy; Laparoscopy; pediatric surgery

Outcome Measures

Primary Outcomes (1)

• Painkiller of help consumption

  Quantity of analgesic of help (Nalbuphine, Nubain®, Dupont Pharma, Paris, France) taken after the surgery.

  up to 24 hours after surgery

Secondary Outcomes (2)

• Pain intensity after surgery

  up to 24 hours

• First demand of analgesic of help

  up to 12 hours

Study Arms (3)

Group 1

ACTIVE COMPARATOR

Curare: Atracurium injection at 0.5 mg/kg

Drug: Curare

Group 2

EXPERIMENTAL

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; Drug: Curare

Group 3

EXPERIMENTAL

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

Other: TAP block with Ropivacaine

Interventions

TAP block with Ropivacaine OTHER

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

Also known as: Transversus abdominis plane (TAP) block with ropivacaine

Group 2; Group 3

Curare DRUG

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

Also known as: Succinylcholine

Group 1; Group 2

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHRU Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Interventions

Ropivacaine; Dental Occlusion; Curare; Succinylcholine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures; Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Onium Compounds

Study Officials

• Maud MM Maniora, MD

  Montpellier University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2015
• First Posted: July 22, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2017
• Last Updated: July 22, 2015

Record last verified: 2015-05

Locations

FR (1)