Clincosm LogoSign in Get a demo

TAP Block With Two Different Doses of Levobupivacaine

Sponsor
Ankara University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02567487
Collaborator
(none)
50
Enrollment
2
Arms
12
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Comparison of TAP Block With Two Different Doses of Levobupivacaine for Postoperative Pain Management in Pediatric Patients
Study Start Date :
Jul 1, 2015
Anticipated Primary Completion Date :
Jan 1, 2016
Anticipated Study Completion Date :
Jul 1, 2016

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. postoperative VAS score <4 at postoperative 24 hours [Postoperative first 24 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Ankara University

    Investigators

    • Study Director: Neslihan Alkis, Ankara University Medical Faculty

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Emel Uyar, Doctor, Ankara University
    ClinicalTrials.gov Identifier:
    NCT02567487
    Other Study ID Numbers:
    • 931893045140401
    First Posted:
    Oct 5, 2015
    Last Update Posted:
    Oct 5, 2015
    Last Verified:
    Oct 1, 2015
    Additional relevant MeSH terms:
    Pain, Postoperative
    Levobupivacaine

    Study Results

    No Results Posted as of Oct 5, 2015