Back to resultsFentanyl 12 Mcg Transdermal Patch For Postoperative Pain
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Fentanyl transdermal patch
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Fentanyl Group
Control group
Arm Description
Patients received the fentanyl 12 mcg transdermal patch (FG, n=38) 8 hours preoperatively and until 24 hours after the surgery
Outcomes
Primary Outcome Measures
Numeric rating score for pain (NRS)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03199157
Brief Title
Fentanyl 12 Mcg Transdermal Patch For Postoperative Pain
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fentanyl Group
Arm Type
Active Comparator
Arm Description
Patients received the fentanyl 12 mcg transdermal patch (FG, n=38) 8 hours preoperatively and until 24 hours after the surgery
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Fentanyl transdermal patch
Intervention Description
Patients received fentanyl 12 mcg transdermal patch group 8 hours preoperatively and until 24 hours after the surgery
Primary Outcome Measure Information:
Title
Numeric rating score for pain (NRS)
Time Frame
Postoperative 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
Fentanyl 12 Mcg Transdermal Patch For Postoperative Pain
We'll reach out to this number within 24 hrs