Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 30 of 458 for:    TRAMADOL

The Analgesic Efficacy of Wound Infiltration With Tramadol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02518438
Recruitment Status : Completed
First Posted : August 7, 2015
Last Update Posted : August 7, 2015
Sponsor:
Information provided by (Responsible Party):
Murat Haliloglu, Yeditepe University Hospital

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Tramadol Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Trial of the Analgesic Efficacy of Wound Infiltration With Tramadol After Cesarean Delivery Under General Anesthesia
Study Start Date : May 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Tramadol

Arm Intervention/treatment
Active Comparator: the tramadol group
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.
Drug: Tramadol
A preprepared 20 ml solution was subcutaneously infiltrated after closure of the uterine incision and the rectus fascia.
Other Name: Placebo (0,9% saline solution)

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



Primary Outcome Measures :
  1. The primary outcome measure in this study was cumulative morphine consumption. [ Time Frame: postoperative 24 hours ]
    The measure of need for analgesics in the immediate postoperative period in this study was cumulative morphine consumption.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518438


Locations
Layout table for location information
Turkey
Yeditepe University Hospital
Istanbul, Kozyatagı, Turkey, 37452
Sponsors and Collaborators
Yeditepe University Hospital

Layout table for additonal information
Responsible Party: Murat Haliloglu, Medical doctor, Yeditepe University Hospital
ClinicalTrials.gov Identifier: NCT02518438     History of Changes
Other Study ID Numbers: 190
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: August 7, 2015
Last Verified: August 2015
Keywords provided by Murat Haliloglu, Yeditepe University Hospital:
Tramadol
Postoperative analgesia
Infiltration
Cesarean section
Additional relevant MeSH terms:
Layout table for MeSH terms
Tramadol
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Pharmaceutical Solutions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Central Nervous System Depressants