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Fentanyl 12 Mcg Transdermal Patch For Postoperative Pain

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ClinicalTrials.gov Identifier: NCT03199157
Recruitment Status : Completed
First Posted : June 26, 2017
Last Update Posted : June 26, 2017
Sponsor:
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 ]


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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
Criteria

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
ClinicalTrials.gov 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
Pain
Neurologic Manifestations
Signs and Symptoms
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics