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Usage of Tramadol With Levobupivacaine for Pain Treatment After Cesarean Section

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01916915
First Posted: August 6, 2013
Last Update Posted: June 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Perihan Ekmekçi, Ufuk University
  Purpose
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.

Condition Intervention Phase
Pain, Postoperative Drug: Tramadol infusion via wound catheter Drug: Levobupivacaine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Addition of Tramadol to Levobupivacaine in Continuous Wound Infusion for Postoperative Pain Treatment in Cesarean Section

Resource links provided by NLM:


Further study details as provided by Perihan Ekmekçi, Ufuk University:

Primary Outcome Measures:
  • lowering of pain as measured by visual analogue scores [ Time Frame: forty eight hours after the operation ]

Secondary Outcome Measures:
  • total additional analgesic consumption [ Time Frame: forty eight hours after the operation ]

Enrollment: 65
Study Start Date: July 2013
Study Completion Date: March 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tramadol 1
1 mg/kg tramadol + 0.25% levobupivacaine 4 ml/h infusion
Drug: Tramadol infusion via wound catheter Drug: Levobupivacaine
Experimental: Tramadol 2
2mg/kg tramadol + 0.25% levobupivacaine 4 ml/h infusion
Drug: Tramadol infusion via wound catheter Drug: Levobupivacaine
Placebo Comparator: Levobupivacaine
0.25% levobupivacaine 4ml/h infusion
Drug: Levobupivacaine

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01916915


Locations
Turkey
Ufuk University Dr Rıdvan Ege Hospital
Ankara, Turkey, 06520
Sponsors and Collaborators
Ufuk University
Investigators
Principal Investigator: Perihan Ekmekçi, Associate Professor Ufuk University Dr Rıdvan Ege Hospital Department of Anesthesiology and Reanimation
  More Information

Responsible Party: Perihan Ekmekçi, Associate Professor, Ufuk University
ClinicalTrials.gov Identifier: NCT01916915     History of Changes
Other Study ID Numbers: 09/06
First Submitted: August 1, 2013
First Posted: August 6, 2013
Last Update Posted: June 29, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Tramadol
Levobupivacaine
Bupivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics