Efficacy of Transdermal Fentanyl Patches in Relief of Acute Postoperative Pain After Mastectomy

Phase 4

• Conditions: Breast Cancer Female
• Interventions: Drug: The Transdermal Therapeutic System-Fentanyl (TTS-F); Device: Intravenous patient-controlled analgesia (PCA) morphine

• Registration Number: NCT03051503
• Lead Sponsor: South Egypt Cancer Institute

Brief Summary

to determine the safety, efficacy and tolerability of transdermal fentanyl in patients undergoing mastectomy, as well as the postoperative consumption of analgesic.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-02
• Study Start: 2017-02-02
• Study First Submitted: 2017-02-03
• Study First Submitted QC: 2017-02-08
• Study First Posted: 2017-02-13
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24
• Primary Completion: 2017-04
• Study Completion: 2017-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The Transdermal Therapeutic System-Fentanyl (TTS-F) group	The Transdermal Therapeutic System-Fentanyl (TTS-F)	(TTS-F) group (n=30) 50ug/h patch, placed 12 hs preoperatively.
Intravenous patient-controlled analgesia (PCA) morphine	Intravenous patient-controlled analgesia (PCA) morphine	IV (PCA) morphine for pain in the postoperative period.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Level of stress hormones	48 hours	Cortisol levels
Side effects related to the opioids	48 hours	Nausea and vomiting; Itching; Respiratory depression.

Trial Locations

Locations (1)

South Egypt Cancer Institute, Assiut University, Assiut, Egypt.; 🇪🇬 Assuit, Egypt