Duloxetine for Postoperative Analgesia After Modified Radical Mastectomy

Status Recruiting

Clinical Trial Summary

The aim of this study is to evaluate the role of duloxetine in controlling pain after radical mastectomy.

Clinical Trial Description

Inadequate control of postoperative pain is associated with increased length of hospital stay, increased hospital cost, sleep disturbance, depression, functional impairment and affects the quality of life. Modified is one of the commonly performed procedures which is associated with severe postoperative pain. Preemptive analgesia is the analgesic treatment initiated before the surgical procedure to prevent central sensitization from the noxious stimuli. Drugs such as gabapentin, pregabalin, serotonin-norepinephrine reuptake inhibitors, dexamethasone, and cyclooxygenase-2 inhibitors have been used for preemptive analgesia. There are contrary results about the role of duloxetine in mangement of acute postoperative pain. Arecent meta-analysis was done in 2020 that concluded that the currently available evidence does not support the clinical use of duloxetine for the management of acute postoperative pain,so we will discuss that in this study. There are many studies that have shown that perioperative use of duloxetine for a few days has a significant effect on reducing postoperative pain and analgesic requirements. Duloxetine is a dual anti-depressant drug that inhibits the neuronal reuptake of serotonin (5-HT) and norepinephrine (NE) modulating the descending inhibitory pain pathways by increasing the availability of serotonin and norepinephrine. Duloxetine is an approved drug for the treatment of post-traumatic depression, major depression, and generalized anxiety disorder. It is also approved for the treatment of various chronic painful syndromes, including neuropathic pain associated with diabetes, chronic musculoskeletal pain, and fibromyalgia. The mechanisms of action so far described suggest that duloxetine may be useful as an adjunct in the treatment of acute postoperative pain. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05442268
Study type	Interventional
Source	Tanta University
Contact	Dina Elfeky, M.B.B.CH.
Phone	0 111 747 2680
Email	dena154452@med.tanta.edu.eg
Status	Recruiting
Phase	N/A
Start date	July 16, 2022
Completion date	January 31, 2023

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.