NCT02567487

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2015

Shorter than P25 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 5, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

October 5, 2015

Status Verified

October 1, 2015

Enrollment Period

6 months

First QC Date

September 17, 2015

Last Update Submit

October 2, 2015

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • postoperative VAS score <4 at postoperative 24 hours

    Postoperative first 24 hours

Study Arms (2)

Group Levobupivacaine high volume

ACTIVE COMPARATOR

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

Drug: Levobupivacaine

Group Levobupivacaine low volume

ACTIVE COMPARATOR

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

Drug: Levobupivacaine

Interventions

LevobupivacaineDRUG

Transversus abdominis plane block with levobupivacaine

Also known as: Chirocaine
Group Levobupivacaine high volumeGroup Levobupivacaine low volume

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Volunteers planned to undergo unilateral inguinal surgery under TAP (ilioinguinal and iliohypogastric block) and general anesthesia
  • Aged between 2 and 12

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Levobupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Neslihan Alkis

    Ankara University Medical Faculty

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

September 17, 2015

First Posted

October 5, 2015

Study Start

July 1, 2015

Primary Completion

January 1, 2016

Study Completion

July 1, 2016

Last Updated

October 5, 2015

Record last verified: 2015-10