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

South Egypt Cancer Institute60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

TRIPLE

Enrollment

Conditions

Breast Cancer Female

Interventions

The Transdermal Therapeutic System-Fentanyl (TTS-F)DRUG

(TTS-F) group (n=30) 50ug/h patch, placed 12 hours preoperatively

Intravenous patient-controlled analgesia (PCA) morphineDEVICE

IV PCA morphine for pain in the postoperative period.

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

South Egypt Cancer Institute, Assiut University, Assiut, Egypt.

Asyut, Egypt

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 48 hours

Visual Analogue Scale

Pain measurement scale

Time frame: 48 hours

Secondary Outcomes

Level of stress hormones

Cortisol levels

Time frame: 48 hours

Side effects related to the opioids

Nausea and vomiting; Itching; Respiratory depression.

Time frame: 48 hours

Central Contacts

mohamad F mohamad, MD

CONTACT

+201093942354 mfaroukma@gmail.com

Data from ClinicalTrials.gov

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