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The Analgesic Efficacy of Wound Infiltration With Tramadol

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Tramadol
Sponsored by
Yeditepe University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring Tramadol, Postoperative analgesia, Infiltration, Cesarean section

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Yeditepe University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

the tramadol group

the placebo group

Arm Description

A preprepared 20 ml solution (tramadol 2 mgkg-1 within a 0.9% saline solution) was subcutaneously infiltrated after closure of the uterine incision and the rectus fascia.

A preprepared 20 ml solution (0,9% saline solution) was subcutaneously infiltrated after closure of the uterine incision and the rectus fascia.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 8, 2015
Last Updated
August 4, 2015
Sponsor
Yeditepe University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02518438
Brief Title
The Analgesic Efficacy of Wound Infiltration With Tramadol
Official Title
A Randomized Trial of the Analgesic Efficacy of Wound Infiltration With Tramadol After Cesarean Delivery Under General Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yeditepe University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Tramadol, Postoperative analgesia, Infiltration, Cesarean section

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the tramadol group
Arm Type
Active Comparator
Arm Description
A preprepared 20 ml solution (tramadol 2 mgkg-1 within a 0.9% saline solution) was subcutaneously infiltrated after closure of the uterine incision and the rectus fascia.
Arm Title
the placebo group
Arm Type
Placebo Comparator
Arm Description
A preprepared 20 ml solution (0,9% saline solution) was subcutaneously infiltrated after closure of the uterine incision and the rectus fascia.
Intervention Type
Drug
Intervention Name(s)
Tramadol
Other Intervention Name(s)
Placebo (0,9% saline solution)
Intervention Description
A preprepared 20 ml solution was subcutaneously infiltrated after closure of the uterine incision and the rectus fascia.
Primary Outcome Measure Information:
Title
The primary outcome measure in this study was cumulative morphine consumption.
Description
The measure of need for analgesics in the immediate postoperative period in this study was cumulative morphine consumption.
Time Frame
postoperative 24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Yeditepe University Hospital
City
Istanbul
State/Province
Kozyatagı
ZIP/Postal Code
37452
Country
Turkey

12. IPD Sharing Statement

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The Analgesic Efficacy of Wound Infiltration With Tramadol

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