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

Breast Cancer Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03051503
• Other study ID #: 228
• Status: Recruiting
• Phase: Phase 4
• First received: February 3, 2017
• Last updated: February 22, 2017
• Start date: February 2, 2017
• Est. completion date: April 2017

Study information

• Verified date: February 2017
• Source: South Egypt Cancer Institute
• Contact: mohamad F mohamad, MD
• Phone: +201093942354
• Email: mfaroukma[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Female
• Pain, Postoperative

Intervention

Drug:
• The Transdermal Therapeutic System-Fentanyl (TTS-F)
(TTS-F) group (n=30) 50ug/h patch, placed 12 hours preoperatively

Device:
• Intravenous patient-controlled analgesia (PCA) morphine
IV PCA morphine for pain in the postoperative period.

Locations

Country	Name	City	State
Egypt	South Egypt Cancer Institute, Assiut University, Assiut, Egypt.	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
South Egypt Cancer Institute

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Visual Analogue Scale	Pain measurement scale	48 hours
Secondary	Level of stress hormones	Cortisol levels	48 hours
Secondary	Side effects related to the opioids	Nausea and vomiting; Itching; Respiratory depression.	48 hours