Duloxetine for Postoperative Analgesia After Modified Radical Mastectomy

T

Tanta University

Status

Enrolling

Conditions

Postoperative Analgesia
Modified Radical Mastectomy

Treatments

Procedure: Acetaminophen group
Procedure: Duloxetine group

Study type

Interventional

Funder types

Other

Identifiers

NCT05442268
35146/12/21

Details and patient eligibility

About

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

Full 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.

Enrollment

40 estimated patients

Sex

Female

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult female patients aged (18 - 60) years undergoing modified radical mastectomy. American Society of Anesthesiologists Classification I-II-III

Exclusion criteria

Known Allergies to duloxetine. Abnormal liver or renal function tests. Narrow angle glaucoma. Being a chronic opioid abuser (more than 3 months) Being on chronic gabapentin or pregabalin (more than 3 months) Being on Monoamine oxidase inhibitor, tricyclic antidepressant, or fluvoxamine. Pregnant female Patients with psychiatric disorders or seizure disorders.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Acetaminophen group
Experimental group
Description:
patients will receive intravenous 500 mg acetaminophen(every 6 hours postoperatively.
Treatment:
Procedure: Acetaminophen group
Duloxetine group
Experimental group
Description:
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)
Treatment:
Procedure: Duloxetine group

Trial contacts and locations

1

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Central trial contact

Dina Elfeky, M.B.B.CH.

Data sourced from clinicaltrials.gov

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