Breast Cancer Female
Conditions
Brief summary
to determine the safety, efficacy and tolerability of transdermal fentanyl in patients undergoing mastectomy, as well as the postoperative consumption of analgesic.
Interventions
DRUGThe Transdermal Therapeutic System-Fentanyl (TTS-F)
(TTS-F) group (n=30) 50ug/h patch, placed 12 hours preoperatively
DEVICEIntravenous patient-controlled analgesia (PCA) morphine
IV PCA morphine for pain in the postoperative period.
Sponsors
South Egypt Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 60 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total dose of morphine consumption in the first 48 hours postoperative | 48 hours | Total dose of I.V. PCA morphine consumption in the first 48 hours postoperative |
| Visual Analogue Scale | 48 hours | Pain measurement scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of stress hormones | 48 hours | Cortisol levels |
| Side effects related to the opioids | 48 hours | Nausea and vomiting; Itching; Respiratory depression. |
Countries
Egypt
Contacts
Primary Contactmohamad F mohamad, MD
Outcome results
None listed