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Clinical Trials/NCT02567487
NCT02567487
Unknown
Phase 4

Comparison of TAP Block With Two Different Doses of Levobupivacaine for Postoperative Pain Management in Pediatric Patients

Ankara University0 sites50 target enrollmentJuly 2015

Overview

Phase
Phase 4
Intervention
Levobupivacaine
Conditions
Pain, Postoperative
Sponsor
Ankara University
Enrollment
50
Primary Endpoint
postoperative VAS score <4 at postoperative 24 hours
Last Updated
10 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
July 2015
End Date
July 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Emel Uyar

Doctor

Ankara University

Eligibility Criteria

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)

Arms & Interventions

Group Levobupivacaine high volume

TAP block with levobupivacaine 0.25% of 0.5 ml/kg under general anesthesia

Intervention: Levobupivacaine

Group Levobupivacaine low volume

TAP block with levobupivacaine 0.25% of 0.25 ml/kg under general anesthesia

Intervention: Levobupivacaine

Outcomes

Primary Outcomes

postoperative VAS score <4 at postoperative 24 hours

Time Frame: Postoperative first 24 hours

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