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Efficacy of Transdermal Fentanyl Patches in Relief of Acute Postoperative Pain After Mastectomy

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.
 
ClinicalTrials.gov Identifier: NCT03051503
Recruitment Status : Unknown
Verified February 2017 by Dr.mohamad farouk mohamad, South Egypt Cancer Institute.
Recruitment status was:  Recruiting
First Posted : February 13, 2017
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Dr.mohamad farouk mohamad, South Egypt Cancer Institute

Study Description
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Brief Summary:
to determine the safety, efficacy and tolerability of transdermal fentanyl in patients undergoing mastectomy, as well as the postoperative consumption of analgesic.

Condition or disease Intervention/treatment Phase
Breast Cancer Female Drug: The Transdermal Therapeutic System-Fentanyl (TTS-F) Device: Intravenous patient-controlled analgesia (PCA) morphine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Efficacy of Transdermal Fentanyl Patches in Relief of Acute Postoperative Pain After Mastectomy
Actual Study Start Date : February 2, 2017
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: The Transdermal Therapeutic System-Fentanyl (TTS-F) group
(TTS-F) group (n=30) 50ug/h patch, placed 12 hs preoperatively.
 Drug: The Transdermal Therapeutic System-Fentanyl (TTS-F)
(TTS-F) group (n=30) 50ug/h patch, placed 12 hours preoperatively
Other Name: Fentanyl patch
Placebo Comparator: Intravenous patient-controlled analgesia (PCA) morphine
IV (PCA) morphine for pain in the postoperative period.
 Device: Intravenous patient-controlled analgesia (PCA) morphine
IV PCA morphine for pain in the postoperative period.
Other Name: IV PCA morphine


Outcome Measures
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Primary Outcome Measures :
  1. Total dose of morphine consumption in the first 48 hours postoperative [ Time Frame: 48 hours ]
    Total dose of I.V. PCA morphine consumption in the first 48 hours postoperative

  2. Visual Analogue Scale [ Time Frame: 48 hours ]
    Pain measurement scale


Secondary Outcome Measures :
  1. Level of stress hormones [ Time Frame: 48 hours ]
    Cortisol levels

  2. Side effects related to the opioids [ Time Frame: 48 hours ]
    Nausea and vomiting; Itching; Respiratory depression.


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051503


Contacts
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Contact: mohamad F mohamad, MD +201093942354 mfaroukma@gmail.com

Locations
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Egypt
South Egypt Cancer Institute, Assiut University, Assiut, Egypt. Recruiting
Assuit, Egypt, 171516
Sponsors and Collaborators
South Egypt Cancer Institute
Investigators
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Study Director: Ahmed H Othman, MD Cancer Institute, Anesthesia, Intensive Care, and Pain Management, South Egypt Cancer Institute, Assiut University, Assiut, Egypt
More Information
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Responsible Party: Dr.mohamad farouk mohamad, lecturer of anesthesia and pain relief, South Egypt Cancer Institute
ClinicalTrials.gov Identifier: NCT03051503    
Other Study ID Numbers: 228
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Fentanyl
Morphine
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