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

South Egypt Cancer Institute

Status and phase: Unknown; Phase 4

Conditions: Breast Cancer Female

Treatments: Drug: The Transdermal Therapeutic System-Fentanyl (TTS-F); Device: Intravenous patient-controlled analgesia (PCA) morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT03051503

228

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: Female

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

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

Active Comparator group

Description:

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

Treatment:

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

Intravenous patient-controlled analgesia (PCA) morphine

Placebo Comparator group

Description:

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

Treatment:

Device: Intravenous patient-controlled analgesia (PCA) morphine