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to determine the safety, efficacy and tolerability of transdermal fentanyl in patients undergoing mastectomy, as well as the postoperative consumption of analgesic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The Transdermal Therapeutic System-Fentanyl (TTS-F) group | Active Comparator | (TTS-F) group (n=30) 50ug/h patch, placed 12 hs preoperatively. |
|
| Intravenous patient-controlled analgesia (PCA) morphine | Placebo Comparator | IV (PCA) morphine for pain in the postoperative period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Transdermal Therapeutic System-Fentanyl (TTS-F) | Drug | (TTS-F) group (n=30) 50ug/h patch, placed 12 hours preoperatively |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 48 hours |
| Visual Analogue Scale | Pain measurement scale | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Level of stress hormones | Cortisol levels | 48 hours |
| Side effects related to the opioids | Nausea and vomiting; Itching; Respiratory depression. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| mohamad F mohamad, MD | Contact | +201093942354 | mfaroukma@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed H Othman, MD | Cancer Institute, Anesthesia, Intensive Care, and Pain Management, South Egypt Cancer Institute, Assiut University, Assiut, Egypt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Egypt Cancer Institute, Assiut University, Assiut, Egypt. | Recruiting | Asyut | 171516 | Egypt |
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| ID | Term |
|---|---|
| D016058 | Analgesia, Patient-Controlled |
| D010323 | Passive Cutaneous Anaphylaxis |
| ID | Term |
|---|---|
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D012882 | Skin Tests |
| D007159 | Immunologic Tests |
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|
| Intravenous patient-controlled analgesia (PCA) morphine | Device | IV PCA morphine for pain in the postoperative period. |
|
|
| 48 hours |
| D019411 |
| Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
| D000937 | Antigen-Antibody Reactions |
| D055633 | Immune System Phenomena |