Overview

This trial is active, not recruiting.

Condition pain, postoperative
Treatment levobupivacaine
Phase phase 4
Sponsor Ankara University
Start date July 2015
End date January 2016
Trial size 50 participants
Trial identifier NCT02567487, 931893045140401

Summary

The aim of the current study is to investigate the effects of two different doses of levobupivacaine in TAP (transversus abdominus plane) block for postoperative management. For this purpose we planned to include 50 children aged between 2 and 12 that will undergo unilateral inguinal surgery.

The doses that will be used in the study were within usual dose limits which is stated in prospectus of the study drug.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose supportive care
Arm
(Active Comparator)
TAP block with levobupivacaine 0.25% of 0.5 ml/kg under general anesthesia
levobupivacaine Chirocaine
Transversus abdominis plane block with levobupivacaine
(Active Comparator)
TAP block with levobupivacaine 0.25% of 0.25 ml/kg under general anesthesia
levobupivacaine Chirocaine
Transversus abdominis plane block with levobupivacaine

Primary Outcomes

Measure
postoperative VAS score <4 at postoperative 24 hours
time frame: Postoperative first 24 hours

Eligibility Criteria

Male or female participants from 2 years up to 12 years old.

Inclusion Criteria: - Volunteers planned to undergo unilateral inguinal surgery under TAP (ilioinguinal and iliohypogastric block) and general anesthesia - Aged between 2 and 12 Exclusion Criteria: - Patients with coagulation dysfunction - Patients with chronic pain - Patients having infection at the site of intervention - Patients with a history of allergy - Patients having chronic diseases (hepatic dysfunction, renal failure)

Additional Information

Official title Comparison of TAP Block With Two Different Doses of Levobupivacaine for Postoperative Pain Management in Pediatric Patients
Description Fifty children undergoing TAP block were randomly divided into two groups as levobupivacaine 0.25% 0.5 ml/kg and levobupivacaine 0.25% 0.25 ml/kg. Postoperative pain was evaluated with observational pain scale and modified pediatric objective pain scale.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Ankara University.