Efficacy of Transdermal Fentanyl Patches in Relief of Acute Postoperative Pain After Mastectomy
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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
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Condition or disease | Intervention/treatment | Phase |
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Breast Cancer Female | Drug: The Transdermal Therapeutic System-Fentanyl (TTS-F) Device: Intravenous patient-controlled analgesia (PCA) morphine | Phase 4 |
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 |

Arm | Intervention/treatment |
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Active Comparator: The Transdermal Therapeutic System-Fentanyl (TTS-F) group
(TTS-F) group (n=30) 50ug/h patch, placed 12 hs preoperatively.
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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.
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Device: Intravenous patient-controlled analgesia (PCA) morphine
IV PCA morphine for pain in the postoperative period.
Other Name: IV PCA morphine |
- 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
- Visual Analogue Scale [ Time Frame: 48 hours ]Pain measurement scale
- Level of stress hormones [ Time Frame: 48 hours ]Cortisol levels
- Side effects related to the opioids [ Time Frame: 48 hours ]Nausea and vomiting; Itching; Respiratory depression.

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Ages Eligible for Study: | 30 Years to 60 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

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
Contact: mohamad F mohamad, MD | +201093942354 | mfaroukma@gmail.com |
Egypt | |
South Egypt Cancer Institute, Assiut University, Assiut, Egypt. | Recruiting |
Assuit, Egypt, 171516 |
Study Director: | Ahmed H Othman, MD | Cancer Institute, Anesthesia, Intensive Care, and Pain Management, South Egypt Cancer Institute, Assiut University, Assiut, Egypt |
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 |
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 |
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 |