The Analgesic Efficacy of Wound Infiltration With Tramadol

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Yeditepe University Hospital

Istanbul, Kozyatagı, 37452, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tramadol

Drug

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

Other names: Placebo (0,9% saline solution)

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Yeditepe University Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Aug 7, 2015
Registry last updated: Aug 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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