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

February 22, 2017 updated by: Dr.mohamad farouk mohamad, South Egypt Cancer Institute
to determine the safety, efficacy and tolerability of transdermal fentanyl in patients undergoing mastectomy, as well as the postoperative consumption of analgesic.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Assuit, Egypt, 171516
        • Recruiting
        • South Egypt Cancer Institute, Assiut University, Assiut, Egypt.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: The Transdermal Therapeutic System-Fentanyl (TTS-F) group
(TTS-F) group (n=30) 50ug/h patch, placed 12 hs preoperatively.
Drug: The Transdermal Therapeutic System-Fentanyl (TTS-F)
(TTS-F) group (n=30) 50ug/h patch, placed 12 hours preoperatively
Other Names:
  • Fentanyl patch
Placebo Comparator: Intravenous patient-controlled analgesia (PCA) morphine
IV (PCA) morphine for pain in the postoperative period.
Device: Intravenous patient-controlled analgesia (PCA) morphine
IV PCA morphine for pain in the postoperative period.
Other Names:
  • IV PCA morphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
48 hours
Visual Analogue Scale
Time Frame: 48 hours
Pain measurement scale
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of stress hormones
Time Frame: 48 hours
Cortisol levels
48 hours
Side effects related to the opioids
Time Frame: 48 hours
Nausea and vomiting; Itching; Respiratory depression.
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Egypt Cancer Institute

Investigators

  • Study Director: Ahmed H Othman, MD, Cancer Institute, Anesthesia, Intensive Care, and Pain Management, South Egypt Cancer Institute, Assiut University, Assiut, Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2017

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

February 3, 2017

First Submitted That Met QC Criteria

February 8, 2017

First Posted (Actual)

February 13, 2017

Study Record Updates

Last Update Posted (Actual)

February 24, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 228

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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