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Usage of Tramadol With Levobupivacaine for Pain Treatment After Cesarean Section

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Tramadol infusion via wound catheter
Levobupivacaine
Sponsored by
Ufuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Ufuk University Dr Rıdvan Ege Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Tramadol 1

Tramadol 2

Levobupivacaine

Arm Description

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

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

0.25% levobupivacaine 4ml/h infusion

Outcomes

Primary Outcome Measures

lowering of pain as measured by visual analogue scores

Secondary Outcome Measures

total additional analgesic consumption

Full Information

First Posted
August 1, 2013
Last Updated
June 28, 2016
Sponsor
Ufuk University
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1. Study Identification

Unique Protocol Identification Number
NCT01916915
Brief Title
Usage of Tramadol With Levobupivacaine for Pain Treatment After Cesarean Section
Official Title
The Effect of Addition of Tramadol to Levobupivacaine in Continuous Wound Infusion for Postoperative Pain Treatment in Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ufuk University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tramadol 1
Arm Type
Experimental
Arm Description
1 mg/kg tramadol + 0.25% levobupivacaine 4 ml/h infusion
Arm Title
Tramadol 2
Arm Type
Experimental
Arm Description
2mg/kg tramadol + 0.25% levobupivacaine 4 ml/h infusion
Arm Title
Levobupivacaine
Arm Type
Placebo Comparator
Arm Description
0.25% levobupivacaine 4ml/h infusion
Intervention Type
Drug
Intervention Name(s)
Tramadol infusion via wound catheter
Intervention Type
Drug
Intervention Name(s)
Levobupivacaine
Primary Outcome Measure Information:
Title
lowering of pain as measured by visual analogue scores
Time Frame
forty eight hours after the operation
Secondary Outcome Measure Information:
Title
total additional analgesic consumption
Time Frame
forty eight hours after the operation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Perihan Ekmekçi, Associate Professor
Organizational Affiliation
Ufuk University Dr Rıdvan Ege Hospital Department of Anesthesiology and Reanimation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ufuk University Dr Rıdvan Ege Hospital
City
Ankara
ZIP/Postal Code
06520
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Usage of Tramadol With Levobupivacaine for Pain Treatment After Cesarean Section

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