Usage of Tramadol With Levobupivacaine for Pain Treatment After Cesarean Section

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Ufuk University
Sponsor:
Information provided by (Responsible Party):
Perihan Ekmekçi, Ufuk University
ClinicalTrials.gov Identifier:
NCT01916915
First received: August 1, 2013
Last updated: August 5, 2013
Last verified: August 2013
  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
Postoperative Pain Following Cesarean Section
Drug: Tramadol infusion via wound catheter
Drug: Levobupivacaine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Ufuk University:

Primary Outcome Measures:
  • lowering of pain as measured by visual analogue scores [ Time Frame: forty eight hours after the operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • total additional analgesic consumption [ Time Frame: forty eight hours after the operation ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2013
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: August 2013 (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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01916915

Contacts
Contact: Perihan Ekmekçi 903122044000 erdogduperi@gmail.com

Locations
Turkey
Ufuk University Dr Rıdvan Ege Hospital Recruiting
Ankara, Turkey, 06520
Contact: Perihan Ekmekçi, MD    903122044000    erdogduperi@gmail.com   
Sub-Investigator: Gamze S Çağlar, Associate Professor         
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

No publications provided

Responsible Party: Perihan Ekmekçi, Associate Professor, Ufuk University
ClinicalTrials.gov Identifier: NCT01916915     History of Changes
Other Study ID Numbers: 09/06
Study First Received: August 1, 2013
Last Updated: August 5, 2013
Health Authority: Turkey: Ministry of Health

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

ClinicalTrials.gov processed this record on July 31, 2014