Usage of Tramadol With Levobupivacaine for Pain Treatment After Cesarean Section

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Perihan Ekmekçi, Ufuk University
ClinicalTrials.gov Identifier:
NCT01916915
First received: August 1, 2013
Last updated: June 28, 2016
Last verified: June 2016
  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
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 ]

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

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
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

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 
Study First Received: August 1, 2013
Last Updated: June 28, 2016
Health Authority: Turkey: Ministry of Health
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on July 21, 2016