The Analgesic Efficacy of Wound Infiltration With Tramadol

NCT ID: NCT02518438

Last Updated: 2015-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Tramadol

Intervention Type DRUG

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

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.

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Tramadol

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

Intervention Type DRUG

Other Intervention Names

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Placebo (0,9% saline solution)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Yeditepe University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Murat Haliloglu

Medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yeditepe University Hospital

Istanbul, Kozyatagı, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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190

Identifier Type: -

Identifier Source: org_study_id

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