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

NCT03051503 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: 228
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (2)

• 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

• Visual Analogue Scale

  Pain measurement scale

  48 hours

Secondary Outcomes (2)

• Level of stress hormones

  48 hours

• Side effects related to the opioids

  48 hours

Study Arms (2)

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

ACTIVE COMPARATOR

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

Drug: The Transdermal Therapeutic System-Fentanyl (TTS-F)

Intravenous patient-controlled analgesia (PCA) morphine

PLACEBO COMPARATOR

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

Device: Intravenous patient-controlled analgesia (PCA) morphine

Interventions

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

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

Also known as: Fentanyl patch

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

Intravenous patient-controlled analgesia (PCA) morphine DEVICE

IV PCA morphine for pain in the postoperative period.

Also known as: IV PCA morphine

Intravenous patient-controlled analgesia (PCA) morphine

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I - II patients
• aged 30-60 years
• body weight ranged between 65-10kg

You may not qualify if:

• 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.

Sponsors & Collaborators

• South Egypt Cancer Institute: lead

Study Sites (1)

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

Asyut, 171516, Egypt

RECRUITING

MeSH Terms

Interventions

Analgesia, Patient-Controlled; Passive Cutaneous Anaphylaxis

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia; Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena

Study Officials

• Ahmed H Othman, MD

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

  STUDY DIRECTOR

Central Study Contacts

mohamad F mohamad, MD

CONTACT

+201093942354; mfaroukma@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and pain relief

Study Record Dates

• First Submitted: February 3, 2017
• First Posted: February 13, 2017
• Study Start: February 2, 2017
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: February 24, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)