TAP Block With Two Different Doses of Levobupivacaine

October 2, 2015 updated by: Emel Uyar, Ankara University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group Levobupivacaine high volume
TAP block with levobupivacaine 0.25% of 0.5 ml/kg under general anesthesia
Drug: Levobupivacaine
Transversus abdominis plane block with levobupivacaine
Other Names:
  • Chirocaine
Active Comparator: Group Levobupivacaine low volume
TAP block with levobupivacaine 0.25% of 0.25 ml/kg under general anesthesia
Drug: Levobupivacaine
Transversus abdominis plane block with levobupivacaine
Other Names:
  • Chirocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postoperative VAS score <4 at postoperative 24 hours
Time Frame: Postoperative first 24 hours
Postoperative first 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Investigators

  • Study Director: Neslihan Alkis, Ankara University Medical Faculty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

September 17, 2015

First Submitted That Met QC Criteria

October 2, 2015

First Posted (Estimate)

October 5, 2015

Study Record Updates

Last Update Posted (Estimate)

October 5, 2015

Last Update Submitted That Met QC Criteria

October 2, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 931893045140401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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