Duloxetine for Postoperative Analgesia After Modified Radical Mastectomy
NCT ID: NCT05442268
Last Updated: 2022-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2022-07-16
2023-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Acetaminophen group
patients will receive intravenous 500 mg acetaminophen(every 6 hours postoperatively.
Acetaminophen group
patients will receive intravenous 500 mg acetaminophen(every 6 hours postoperatively
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)
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
Interventions
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Acetaminophen group
patients will receive intravenous 500 mg acetaminophen(every 6 hours postoperatively
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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
60 Years
FEMALE
No
Sponsors
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Tanta University
OTHER
Responsible Party
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Dina Abdel monem Elfeky
Principal investigator
Locations
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Tanta University hospitals
Tanta, Elgarbia, Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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35146/12/21
Identifier Type: -
Identifier Source: org_study_id
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