Transversus Abdominis Plane Block for Laparoscopic Appendicectomy in Children

Not Applicable

• Conditions: Laparoscopic Appendectomy
• Interventions: Other: TAP block with Ropivacaine; Drug: Curare

• Registration Number: NCT02505841
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-05
• Study Start: 2015-05
• Primary Completion: 2015-05
• Study First Submitted: 2015-06-22
• Study First Submitted QC: 2015-07-20
• Last Update Submitted: 2015-07-20
• Study First Posted: 2015-07-22
• Last Update Posted: 2015-07-22
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	TAP block with Ropivacaine	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 1	Curare	Curare: Atracurium injection at 0.5 mg/kg
Group 3	TAP block with Ropivacaine	TAP block: Ultrasound-guided transversus abdominis plane block wih Ropivacaine injection 0.2% at 0.3 ml/kg
Group 2	Curare	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

Primary Outcome Measures

Name	Time	Method
Painkiller of help consumption	up to 24 hours after surgery	Quantity of analgesic of help (Nalbuphine, Nubain®, Dupont Pharma, Paris, France) taken after the surgery.

Secondary Outcome Measures

Name	Time	Method
Pain intensity after surgery	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.
First demand of analgesic of help	up to 12 hours	First demand of analgesic of help (Nubain ®) after the surgery

Trial Locations

Locations (1)

CHRU Montpellier; 🇫🇷 Montpellier, France