Transversus Abdominis Plane Block for Laparoscopic Appendicectomy in Children

Laparoscopic Appendectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02505841
• Other study ID #: 9488
• Secondary ID: 2014-A01431-46
• Status: Active, not recruiting
• Phase: N/A
• First received: June 22, 2015
• Last updated: July 20, 2015
• Start date: May 2015
• Est. completion date: June 2017

Study information

• Verified date: May 2015
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: June 2017
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 12 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Laparoscopic Appendectomy

Intervention

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

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

Locations

Country	Name	City	State
France	CHRU Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pain intensity after surgery	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	No
Secondary	First demand of analgesic of help	First demand of analgesic of help (Nubain ®) after the surgery	up to 12 hours	No