NCT05442268

Duloxetine for Postoperative Analgesia After Modified Radical Mastectomy

Duloxetine for Post Operative Analgesia After Modified Radical Mastectomy:A Randomized Controlled Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Tanta University · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Modified Radical Mastectomy
• Postoperative Analgesia

Interventions

Type	Name	Description
PROCEDURE	Acetaminophen group	patients will receive intravenous 500 mg acetaminophen(every 6 hours postoperatively
PROCEDURE	Duloxetine group	Patients will receive duloxetine 30 mg every 12 hours for 3 days before surgery, 30 mg 2 hours preoperatively and 30 mg 12 hours postoperatively and intravenous 500 mg acetaminophen every 6 hours postoperatively

Timeline

• Start date: 2022-07-16
• Primary completion: 2023-01-31
• Completion: 2023-01-31
• First posted: 2022-07-01
• Last updated: 2022-07-20

Locations

1 site across 1 country: Egypt