TAP Block With Two Different Doses of Levobupivacaine

NCT ID: NCT02567487

Last Updated: 2015-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain, Postoperative

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group Levobupivacaine high volume

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

Group Type ACTIVE_COMPARATOR

Levobupivacaine

Intervention Type DRUG

Transversus abdominis plane block with levobupivacaine

Group Levobupivacaine low volume

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

Group Type ACTIVE_COMPARATOR

Levobupivacaine

Intervention Type DRUG

Transversus abdominis plane block with levobupivacaine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Levobupivacaine

Transversus abdominis plane block with levobupivacaine

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Chirocaine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ankara University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Emel Uyar

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Neslihan Alkis

Role: STUDY_DIRECTOR

Ankara University Medical Faculty

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

931893045140401

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.