Clinical trial · Interventional
Efficacy of Transdermal Fentanyl Patches in Relief of Acute Postoperative Pain After Mastectomy
NCT03051503CI-TRIAL-00026152unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
to determine the safety, efficacy and tolerability of transdermal fentanyl in patients undergoing mastectomy, as well as the postoperative consumption of analgesic.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intravenous patient-controlled analgesia (PCA) morphine | Device | — | UNRESOLVED |
| The Transdermal Therapeutic System-Fentanyl (TTS-F) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- The Transdermal Therapeutic System-Fentanyl (TTS-F) group
- description
- (TTS-F) group (n=30) 50ug/h patch, placed 12 hs preoperatively.
- interventionNames
- Drug: The Transdermal Therapeutic System-Fentanyl (TTS-F)
- type
- PLACEBO_COMPARATOR
- label
- Intravenous patient-controlled analgesia (PCA) morphine
- description
- IV (PCA) morphine for pain in the postoperative period.
- interventionNames
- Device: Intravenous patient-controlled analgesia (PCA) morphine
Primary outcomes (2)
- measure
- Total dose of morphine consumption in the first 48 hours postoperative
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.