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Fentanyl 12 Mcg Transdermal Patch For Postoperative Pain

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. Identifier: NCT03199157
Recruitment Status : Completed
First Posted : June 26, 2017
Last Update Posted : June 26, 2017
Information provided by (Responsible Party):
Oya Yalcin Cok, Baskent University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Fentanyl transdermal patch Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effect Of Fentanyl 12 Mcg Transdermal Patch On Postoperative Pain Following Unilateral, Single-Level Laminectomy/Discectomy: A Randomized, Controlled, Double-Blind Study
Actual Study Start Date : March 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Fentanyl Group
Patients received the fentanyl 12 mcg transdermal patch (FG, n=38) 8 hours preoperatively and until 24 hours after the surgery
Drug: Fentanyl transdermal patch
Patients received fentanyl 12 mcg transdermal patch group 8 hours preoperatively and until 24 hours after the surgery

No Intervention: Control group

Primary Outcome Measures :
  1. Numeric rating score for pain (NRS) [ Time Frame: Postoperative 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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Responsible Party: Oya Yalcin Cok, Medical Doctor, Baskent University Identifier: NCT03199157     History of Changes
Other Study ID Numbers: KA14-66
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: June 26, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General