Usage of Tramadol With Levobupivacaine for Pain Treatment After Cesarean Section

June 28, 2016 updated by: Perihan Ekmekçi, Ufuk University

The Effect of Addition of Tramadol to Levobupivacaine in Continuous Wound Infusion for Postoperative Pain Treatment in Cesarean Section

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06520
        • Ufuk University Dr Rıdvan Ege Hospital

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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tramadol 1
1 mg/kg tramadol + 0.25% levobupivacaine 4 ml/h infusion
Drug: Levobupivacaine
Drug: Tramadol infusion via wound catheter
Experimental: Tramadol 2
2mg/kg tramadol + 0.25% levobupivacaine 4 ml/h infusion
Drug: Levobupivacaine
Drug: Tramadol infusion via wound catheter
Placebo Comparator: Levobupivacaine
0.25% levobupivacaine 4ml/h infusion
Drug: Levobupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
lowering of pain as measured by visual analogue scores
Time Frame: forty eight hours after the operation
forty eight hours after the operation

Secondary Outcome Measures

Outcome Measure
Time Frame
total additional analgesic consumption
Time Frame: forty eight hours after the operation
forty eight hours after the operation

Collaborators and Investigators

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

Sponsor

Ufuk University

Investigators

  • Principal Investigator: Perihan Ekmekçi, Associate Professor, Ufuk University Dr Rıdvan Ege Hospital Department of Anesthesiology and Reanimation

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, 2013

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

August 1, 2013

First Submitted That Met QC Criteria

August 5, 2013

First Posted (Estimate)

August 6, 2013

Study Record Updates

Last Update Posted (Estimate)

June 29, 2016

Last Update Submitted That Met QC Criteria

June 28, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09/06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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