The Analgesic Efficacy of Wound Infiltration With Tramadol
A Randomized Trial of the Analgesic Efficacy of Wound Infiltration With Tramadol After Cesarean Delivery Under General Anesthesia
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 postoperative-pain
Started May 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 8, 2015
CompletedFirst Posted
Study publicly available on registry
August 7, 2015
CompletedAugust 7, 2015
August 1, 2015
10 months
July 8, 2015
August 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
the tramadol group
ACTIVE COMPARATORA 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.
the placebo group
PLACEBO COMPARATORA preprepared 20 ml solution (0,9% saline solution) was subcutaneously infiltrated after closure of the uterine incision and the rectus fascia.
Interventions
A preprepared 20 ml solution was subcutaneously infiltrated after closure of the uterine incision and the rectus fascia.
Eligibility Criteria
You may qualify if:
- Nulliparity
- Gestation age between 37-40 weeks
- CS under general anesthesia
You may not qualify if:
- Pre-eclampsia
- Cardiovascular problems
- Allergy to any of the study medications
- Chronic preoperative pain
- Regular analgesic use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yeditepe University Hospital
Istanbul, Kozyatagı, 37452, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical doctor
Study Record Dates
First Submitted
July 8, 2015
First Posted
August 7, 2015
Study Start
May 1, 2012
Primary Completion
March 1, 2013
Study Completion
May 1, 2013
Last Updated
August 7, 2015
Record last verified: 2015-08