ClinicalTrials.gov
ClinicalTrials.gov Menu

Usage of Tramadol With Levobupivacaine for Pain Treatment After Cesarean Section

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.
ClinicalTrials.gov Identifier: NCT01916915
Recruitment Status : Completed
First Posted : August 6, 2013
Last Update Posted : June 29, 2016
Sponsor:
Information provided by (Responsible Party):
Perihan Ekmekçi, Ufuk University

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Tramadol infusion via wound catheter Drug: Levobupivacaine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
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
Study Start Date : July 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section
Drug Information available for: Tramadol
U.S. FDA Resources

Arm Intervention/treatment
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



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

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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)

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

Responsible Party: Perihan Ekmekçi, Associate Professor, Ufuk University
ClinicalTrials.gov Identifier: NCT01916915     History of Changes
Other Study ID Numbers: 09/06
First Posted: August 6, 2013    Key Record Dates
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