Modified Radical MastectomyNCT05442268
Duloxetine for Postoperative Analgesia After Modified Radical Mastectomy
A study testing Acetaminophen group and Duloxetine group in people with Modified Radical Mastectomy and Postoperative Analgesia, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the role of duloxetine in controlling pain after radical mastectomy. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Modified Radical Mastectomy, Postoperative Analgesia
- What is being tested?
- Acetaminophen group and Duloxetine group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Jul 2022to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Adult female patients aged (18 - 60) years undergoing modified radical mastectomy. American Society of Anesthesiologists Classification I-II-III
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University hospitals
Tanta, Elgarbia
Dina Elfeky, M.B.B.CH, dena154452@med.tanta.edu.eg
About this study
Official title: Duloxetine for Post Operative Analgesia After Modified Radical Mastectomy:A Randomized Controlled Study
The aim of this study is to evaluate the role of duloxetine in controlling pain after radical mastectomy.
Read the 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.
- Being tested
- Acetaminophen group, Duloxetine group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetaminophen groupProcedure or surgery
patients will receive intravenous 500 mg acetaminophen(every 6 hours postoperatively
Duloxetine groupProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen group | Experimental | patients will receive intravenous 500 mg acetaminophen(every 6 hours postoperatively. Receives: Procedure: Acetaminophen group |
| Duloxetine group | Experimental | 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) Receives: Procedure: Duloxetine group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
Postoperative Total morphine consumption will be recorded
Measured: 48 hours postoperatively
Secondary outcomes (5)
First analgesic request
First analgesic request will be recorded
Measured: 24 hours postoperatively
Post-operative pain
Post-operative pain will be assessed by visual analogue score (VAS) from 0-10 scale 0 (no pain) to 10 (the worst imaginable pain) at 2,4,6 h then every 6h
Measured: 48 hours postoperatively.
Heart rate
Heart rate will be measured every 30 minutes intraoperative and at 0 hour (direct postoperative) at post anesthesia care unit then at 2,4,6 hours at ward then every 6 hours for 48 hours postoperatively
Measured: 48 hours postoperatively
Mean arterial blood pressure
Mean arterial blood pressure will be measured every 30 minutes intraoperative and at 0 hour (direct postoperative) at post anesthesia care unit then at 2,4,6 hours at ward then every 6 hours for 48 hours postoperatively
Measured: 48 hours postoperatively
Adverse effects
Hypotension, Bradycardia, nausea, dry mouth,diarrhea, constipation,insomnia, somnolence, fatigue, hyperhidrosis and pruritus will be observed and treated accordingly
Measured: 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start16 Jul 2022
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Modified Radical MastectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Abdel monem Elfeky, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442268
- Sponsor's protocol ID
- 35146/12/21
- Status last verified
- Jul 2022
- First submitted
- 28 Jun 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available under a reasonable request from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duloxetine for Post Operative Analgesia After Modified Radical Mastectomy:A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05442268
- Acronym / sponsor ID
- 35146/12/21
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 16 Jul 2022 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 1 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen group | Experimental | Procedure: Acetaminophen grouppatients will receive intravenous 500 mg acetaminophen(every 6 hours postoperatively. |
| Duloxetine group | Experimental | Procedure: Duloxetine groupPatients 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) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult female patients aged (18 - 60) years undergoing modified radical mastectomy. American Society of Anesthesiologists Classification I-II-III
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetaminophen grouppatients will receive intravenous 500 mg acetaminophen(every 6 hours postoperatively | Procedure or surgery | Acetaminophen group |
| Duloxetine groupPatients 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 | Procedure or surgery | Duloxetine group |
Primary outcome
Total morphine consumption
Time frame: 48 hours postoperatively
Postoperative Total morphine consumption will be recorded
5 secondary outcomes
First analgesic request
Time frame: 24 hours postoperatively
Post-operative pain
Time frame: 48 hours postoperatively.
Heart rate
Time frame: 48 hours postoperatively
Mean arterial blood pressure
Time frame: 48 hours postoperatively
Adverse effects
Time frame: 48 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: Yes. Data will be available under a reasonable request from the corresponding author
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetaminophen group and Duloxetine group in people with Modified Radical Mastectomy and Postoperative Analgesia, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dina Elfeky, M.B.B.CH. (0 111 747 2680 ext. +2, dena154452@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine consumption (time frame: 48 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.