Fentanyl 12 Mcg Transdermal Patch For Postoperative Pain

NCT ID: NCT03199157

Last Updated: 2017-06-26

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

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-12-31

Brief Summary

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The investigators designed a prospective randomized study to investigate the effect of fentanyl 12 mcg transdermal patch on postoperative pain following unilateral, single-level laminectomy/discectomy.

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Fentanyl Group

Patients received the fentanyl 12 mcg transdermal patch (FG, n=38) 8 hours preoperatively and until 24 hours after the surgery

Group Type ACTIVE_COMPARATOR

Fentanyl transdermal patch

Intervention Type DRUG

Patients received fentanyl 12 mcg transdermal patch group 8 hours preoperatively and until 24 hours after the surgery

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fentanyl transdermal patch

Patients received fentanyl 12 mcg transdermal patch group 8 hours preoperatively and until 24 hours after the surgery

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients between the ages of 20-70 years
* ASA physical status 1-2 patients undergoing single-level laminectomy/discectomy

Exclusion Criteria

* A history of allergy to any study drugs
* History of opioid use, obstructive sleep apnea
* Any psychological disorders
* hepatic or renal failure
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Baskent University

OTHER

Sponsor Role lead

Responsible Party

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Oya Yalcin Cok

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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KA14-66

Identifier Type: -

Identifier Source: org_study_id

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