Usage of Tramadol With Levobupivacaine for Pain Treatment After Cesarean Section

Pain, Postoperative Clinical Trial

Official title:

The Effect of Addition of Tramadol to Levobupivacaine in Continuous Wound Infusion for Postoperative Pain Treatment in Cesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01916915
• Other study ID #: 09/06
• Status: Completed
• Phase: Phase 4
• First received: August 1, 2013
• Last updated: June 28, 2016
• Start date: July 2013
• Est. completion date: March 2016

Study information

• Verified date: June 2016
• Source: Ufuk University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Tramadol infusion via wound catheter

• Levobupivacaine

Locations

Country	Name	City	State
Turkey	Ufuk University Dr Ridvan Ege Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ufuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lowering of pain as measured by visual analogue scores		forty eight hours after the operation	No
Secondary	total additional analgesic consumption		forty eight hours after the operation	No