The Analgesic Efficacy of Wound Infiltration With Tramadol

Postoperative Pain Clinical Trial

Official title:

A Randomized Trial of the Analgesic Efficacy of Wound Infiltration With Tramadol After Cesarean Delivery Under General Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02518438
• Other study ID #: 190
• Status: Completed
• Phase: Phase 4
• First received: July 8, 2015
• Last updated: August 4, 2015
• Start date: May 2012
• Est. completion date: May 2013

Study information

• Verified date: August 2015
• Source: Yeditepe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This double-blind, randomized trial examined whether tramadol wound infiltration decreased postoperative pain following cesarean delivery under general anesthesia or reduced the need for analgesics in the immediate postoperative period. Patients in the tramadol group consumed significantly less morphine at all time intervals than those in the control group. The investigators suggest that the use of wound infiltration with tramadol may be a useful technique in patients who undergo cesarean section under general anesthesia to reduce postoperative pain, improve recovery, and facilitate early contact of mothers with their babies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Nulliparity

• Gestation age between 37-40 weeks

• CS under general anesthesia

Exclusion Criteria:

• Pre-eclampsia

• Cardiovascular problems

• Allergy to any of the study medications

• Chronic preoperative pain

• Regular analgesic use

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Tramadol
A preprepared 20 ml solution was subcutaneously infiltrated after closure of the uterine incision and the rectus fascia.

Locations

Country	Name	City	State
Turkey	Yeditepe University Hospital	Istanbul	Kozyatagi

Sponsors (1)

Lead Sponsor	Collaborator
Yeditepe University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure in this study was cumulative morphine consumption.	The measure of need for analgesics in the immediate postoperative period in this study was cumulative morphine consumption.	postoperative 24 hours	No