Efficacy of Transdermal Fentanyl Patches in Relief of Acute Postoperative Pain After Mastectomy
Overview
- Phase
- Phase 4
- Intervention
- The Transdermal Therapeutic System-Fentanyl (TTS-F)
- Conditions
- Breast Cancer Female
- Sponsor
- South Egypt Cancer Institute
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Total dose of morphine consumption in the first 48 hours postoperative
- Last Updated
- 9 years ago
Overview
Brief Summary
to determine the safety, efficacy and tolerability of transdermal fentanyl in patients undergoing mastectomy, as well as the postoperative consumption of analgesic.
Investigators
Dr.mohamad farouk mohamad
lecturer of anesthesia and pain relief
South Egypt Cancer Institute
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.
Arms & Interventions
The Transdermal Therapeutic System-Fentanyl (TTS-F) group
(TTS-F) group (n=30) 50ug/h patch, placed 12 hs preoperatively.
Intervention: The Transdermal Therapeutic System-Fentanyl (TTS-F)
Intravenous patient-controlled analgesia (PCA) morphine
IV (PCA) morphine for pain in the postoperative period.
Intervention: Intravenous patient-controlled analgesia (PCA) morphine
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Level of stress hormones(48 hours)
- Side effects related to the opioids(48 hours)