Usage of Tramadol With Levobupivacaine for Pain Treatment After Cesarean Section

NCT ID: NCT01916915

Last Updated: 2016-06-29

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2016-03-31

Brief Summary

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Patients experience considerable amount of pain after cesarean section. The aim of this study is to investigate the effect of tramadol (an opioid pain killer) added to levobupivacaine (a local anesthetic) in continuous wound infusion (which is done by placing a catheter in the incision) after cesarean sections.

Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tramadol 1

1 mg/kg tramadol + 0.25% levobupivacaine 4 ml/h infusion

Group Type EXPERIMENTAL

Tramadol infusion via wound catheter

Intervention Type DRUG

Levobupivacaine

Intervention Type DRUG

Tramadol 2

2mg/kg tramadol + 0.25% levobupivacaine 4 ml/h infusion

Group Type EXPERIMENTAL

Tramadol infusion via wound catheter

Intervention Type DRUG

Levobupivacaine

Intervention Type DRUG

Levobupivacaine

0.25% levobupivacaine 4ml/h infusion

Group Type PLACEBO_COMPARATOR

Levobupivacaine

Intervention Type DRUG

Interventions

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Tramadol infusion via wound catheter

Intervention Type DRUG

Levobupivacaine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Planned cesarean section
* American Society of Anesthesiologists Class I-II

Exclusion Criteria

* Patients refusing to enroll in the study
* Serious coagulopathy
* Serious systemic disease
* Story of allergy to drugs being used in the study
* Morbid obesity (Body mass index \> 30)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ufuk University

OTHER

Sponsor Role lead

Responsible Party

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Perihan Ekmekçi

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Perihan Ekmekçi, Associate Professor

Role: PRINCIPAL_INVESTIGATOR

Ufuk University Dr Rıdvan Ege Hospital Department of Anesthesiology and Reanimation

Locations

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Ufuk University Dr Rıdvan Ege Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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09/06

Identifier Type: -

Identifier Source: org_study_id

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