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Clinical Trials/NCT03051503
NCT03051503
Unknown
Phase 4

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

South Egypt Cancer Institute1 site in 1 country60 target enrollmentFebruary 2, 2017

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.

Registry
clinicaltrials.gov
Start Date
February 2, 2017
End Date
April 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
South Egypt Cancer Institute
Responsible Party
Principal Investigator
Principal Investigator

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)

Study Sites (1)

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