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

NCT ID: NCT03051503

Last Updated: 2017-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-02

Study Completion Date

2017-04-30

Brief Summary

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

Detailed Description

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Conditions

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Breast Cancer Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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

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

Group Type ACTIVE_COMPARATOR

The Transdermal Therapeutic System-Fentanyl (TTS-F)

Intervention Type DRUG

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

Intravenous patient-controlled analgesia (PCA) morphine

IV (PCA) morphine for pain in the postoperative period.

Group Type PLACEBO_COMPARATOR

Intravenous patient-controlled analgesia (PCA) morphine

Intervention Type DEVICE

IV PCA morphine for pain in the postoperative period.

Interventions

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The Transdermal Therapeutic System-Fentanyl (TTS-F)

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

Intervention Type DRUG

Intravenous patient-controlled analgesia (PCA) morphine

IV PCA morphine for pain in the postoperative period.

Intervention Type DEVICE

Other Intervention Names

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Fentanyl patch IV PCA morphine

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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South Egypt Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Dr.mohamad farouk mohamad

lecturer of anesthesia and pain relief

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed H Othman, MD

Role: STUDY_DIRECTOR

Cancer Institute, Anesthesia, Intensive Care, and Pain Management, South Egypt Cancer Institute, Assiut University, Assiut, Egypt

Locations

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

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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mohamad F mohamad, MD

Role: CONTACT

+201093942354

Other Identifiers

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228

Identifier Type: -

Identifier Source: org_study_id

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