Back to resultsEfficacy of Transdermal Fentanyl Patches in Relief of Acute Postoperative Pain After Mastectomy
Primary Purpose
Breast Cancer Female
Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
The Transdermal Therapeutic System-Fentanyl (TTS-F)
Intravenous patient-controlled analgesia (PCA) morphine
Sponsored by
About this trial
This is an interventional health services research trial for Breast Cancer Female
Eligibility Criteria
Inclusion Criteria:
- ASA I - II patients
- aged 30-60 years
- body weight ranged between 65-10kg
Exclusion Criteria:
- Patients with history of allergy to morphine
- chronic intake of analgesics or non-steroidal anti-inflammatory drug 24 h prior to surgery,
- there was a history of a psychiatric disorder patients weight was less then 50kg.
- impaired kidney function.
Sites / Locations
- South Egypt Cancer Institute, Assiut University, Assiut, Egypt.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
The Transdermal Therapeutic System-Fentanyl (TTS-F) group
Intravenous patient-controlled analgesia (PCA) morphine
Arm Description
(TTS-F) group (n=30) 50ug/h patch, placed 12 hs preoperatively.
IV (PCA) morphine for pain in the postoperative period.
Outcomes
Primary Outcome Measures
Total dose of morphine consumption in the first 48 hours postoperative
Total dose of I.V. PCA morphine consumption in the first 48 hours postoperative
Visual Analogue Scale
Pain measurement scale
Secondary Outcome Measures
Level of stress hormones
Cortisol levels
Side effects related to the opioids
Nausea and vomiting; Itching; Respiratory depression.
Full Information
NCT ID
NCT03051503
First Posted
February 3, 2017
Last Updated
February 22, 2017
Sponsor
South Egypt Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT03051503
Brief Title
Efficacy of Transdermal Fentanyl Patches in Relief of Acute Postoperative Pain After Mastectomy
Official Title
Efficacy of Transdermal Fentanyl Patches in Relief of Acute Postoperative Pain After Mastectomy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2, 2017 (Actual)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
April 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Egypt Cancer Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
to determine the safety, efficacy and tolerability of transdermal fentanyl in patients undergoing mastectomy, as well as the postoperative consumption of analgesic.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The Transdermal Therapeutic System-Fentanyl (TTS-F) group
Arm Type
Active Comparator
Arm Description
(TTS-F) group (n=30) 50ug/h patch, placed 12 hs preoperatively.
Arm Title
Intravenous patient-controlled analgesia (PCA) morphine
Arm Type
Placebo Comparator
Arm Description
IV (PCA) morphine for pain in the postoperative period.
Intervention Type
Drug
Intervention Name(s)
The Transdermal Therapeutic System-Fentanyl (TTS-F)
Other Intervention Name(s)
Fentanyl patch
Intervention Description
(TTS-F) group (n=30) 50ug/h patch, placed 12 hours preoperatively
Intervention Type
Device
Intervention Name(s)
Intravenous patient-controlled analgesia (PCA) morphine
Other Intervention Name(s)
IV PCA morphine
Intervention Description
IV PCA morphine for pain in the postoperative period.
Primary Outcome Measure Information:
Title
Total dose of morphine consumption in the first 48 hours postoperative
Description
Total dose of I.V. PCA morphine consumption in the first 48 hours postoperative
Time Frame
48 hours
Title
Visual Analogue Scale
Description
Pain measurement scale
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Level of stress hormones
Description
Cortisol levels
Time Frame
48 hours
Title
Side effects related to the opioids
Description
Nausea and vomiting; Itching; Respiratory depression.
Time Frame
48 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA I - II patients
aged 30-60 years
body weight ranged between 65-10kg
Exclusion Criteria:
Patients with history of allergy to morphine
chronic intake of analgesics or non-steroidal anti-inflammatory drug 24 h prior to surgery,
there was a history of a psychiatric disorder patients weight was less then 50kg.
impaired kidney function.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mohamad F mohamad, MD
Phone
+201093942354
Email
mfaroukma@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed H Othman, MD
Organizational Affiliation
Cancer Institute, Anesthesia, Intensive Care, and Pain Management, South Egypt Cancer Institute, Assiut University, Assiut, Egypt
Official's Role
Study Director
Facility Information:
Facility Name
South Egypt Cancer Institute, Assiut University, Assiut, Egypt.
City
Assuit
ZIP/Postal Code
171516
Country
Egypt
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Efficacy of Transdermal Fentanyl Patches in Relief of Acute Postoperative Pain After Mastectomy
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