DuloxetineNCT06087211
Pain Relieving Potentials of Combination of Oral Duloxetine and Intravenous Magnesium Sulphate in Post Mastectomy Pain
A study testing Magnesium sulphate and Duloxetine and Duloxetine in people with Duloxetine and Magnesium Sulphate, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
This study aims to evaluate the effect of combined duloxetine and IV Magnesium sulphate to decrease acute and chronic post mastectomy pain. The study will be conducted in National Cancer Institute and all the participants will be enrolled from female patients scheduled for modified radical mastectomy under general… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Duloxetine, Magnesium Sulphate, Post-mastectomy Pain Syndrome
- What is being tested?
- Magnesium sulphate and Duloxetine and Duloxetine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2023to 1 Jan 2025
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 65 years old.
- American Society of Anesthesiologists (ASA) physical I-II
- Scheduled for modified radical mastectomy (MRM) under general anesthesia.
Who cannot join
- Liver or kidney disease
- Patient with previous chronic pain on opioids
- Patients on antidepressants and antipsychotics.
- Allergies to study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Relieving Potentials of Preoperative Combination of Single Dose Oral Duloxetine and Intravenous Magnesium Sulphate in Acute and Chronic Post Mastectomy Pain: A Randomized Controlled Trial
This study aims to evaluate the effect of combined duloxetine and IV Magnesium sulphate to decrease acute and chronic post mastectomy pain.
The study will be conducted in National Cancer Institute and all the participants will be enrolled from female patients scheduled for modified radical mastectomy under general anesthesia in National Cancer Institute, Cairo University.
Read the detailed description
It has been reported recently that Duloxetine improved the quality of recovery in patients subjected to hysterectomy. In this context, mastectomy has a negative consequence starting from cancer diagnosis to the squeal of cancer-related treatments and it has been estimated that 20%-30% of patients with breast cancer suffer from depression and anxiety. Magnesium also antagonizes the release of inflammatory mediators such as histamine, serotonin, and cytokines in peripheral tissues.
- Being tested
- Magnesium sulphate and Duloxetine, Duloxetine, Placebo and normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulphate and DuloxetineDrug
Also called magnesium and cymbalta
Patients received Duloxetine 30mg orally and an intravenous infusion of magnesium sulphate 50mg/kg mixed with 200 ml of normal saline.
DuloxetineDrug
Also called cymbalta
Patients received Duloxetine 30mg orally and 200 ml of normal saline.
Placebo and normal salineDrug
Also called placebo
Patients received a placebo capsule and an intravenous infusion of 200 mL of normal saline.
| Study group | Role | What they receive |
|---|---|---|
| DM group | Active comparator | Patients received Duloxetine 30mg orally and an intravenous infusion of magnesium sulphate 50mg/kg mixed with 200 ml of normal saline. Receives: Drug: Magnesium sulphate and Duloxetine |
| D group | Active comparator | Patients received Duloxetine 30mg orally and 200 ml of normal saline. Receives: Drug: Duloxetine |
| Control group | Placebo comparator | Patients received a placebo capsule and an intravenous infusion of 200 mL of normal saline Receives: Drug: Placebo and normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first analgesic request
Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administared).
Measured: 48 hours postoperatively
Secondary outcomes (5)
Total morphine consumption
Postoperative analgesia is composed of PCA-morphine, set to deliver 2 mg boluses on-demand without background infusion with a lockout period of 10 min and regular intravenous paracetamol, one gram every 8 h.
Measured: 48 hours postoperatively
Degree of pain
Each patient was instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be assessed at post-anesthesia care unit (PACU), 1, 2, 4, 6, 8, 12, 24, 36 and 48 h postoperatively.
Measured: 48 hours postoperatively
Incidence of post-mastectomy pain syndrome
Incidence of post-mastectomy pain syndrome was determined at 8- and 12-weeks post-mastectomy.
Measured: 12 weeks postoperatively
Degree of patient satisfaction
The degree of patient satisfaction was assessed on a 5-point Likert scale (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied).
Measured: 48 hours postoperatively
Incidence of adverse events
Incidence of adverse events such as bradycardia, hypotension, postoperative nausea and vomiting (PONV) were recorded.
Measured: at 8 weeks postoperative and 12 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start10 Oct 2023
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DuloxetineStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norma Osama Abdalla Zayed, National Cancer Institute, Egypt
- Investigators
- Ahmed s abdelgalil, MD, Principal investigator, assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087211
- Sponsor's protocol ID
- AP2307-301-002
- Status last verified
- Jul 2025
- First submitted
- 11 Oct 2023
- Last updated
- 5 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Relieving Potentials of Preoperative Combination of Single Dose Oral Duloxetine and Intravenous Magnesium Sulphate in Acute and Chronic Post Mastectomy Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06087211
- Acronym / sponsor ID
- AP2307-301-002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 17 Oct 2023 (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.
This study aims to evaluate the effect of combined duloxetine and IV Magnesium sulphate to decrease acute and chronic post mastectomy pain.
The study will be conducted in National Cancer Institute and all the participants will be enrolled from female patients scheduled for modified radical mastectomy under general anesthesia in National Cancer Institute, Cairo University.
Detailed description
It has been reported recently that Duloxetine improved the quality of recovery in patients subjected to hysterectomy. In this context, mastectomy has a negative consequence starting from cancer diagnosis to the squeal of cancer-related treatments and it has been estimated that 20%-30% of patients with breast cancer suffer from depression and anxiety. Magnesium also antagonizes the release of inflammatory mediators such as histamine, serotonin, and cytokines in peripheral tissues.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DM group | Active comparator | Drug: Magnesium sulphate and DuloxetinePatients received Duloxetine 30mg orally and an intravenous infusion of magnesium sulphate 50mg/kg mixed with 200 ml of normal saline. |
| D group | Active comparator | Drug: DuloxetinePatients received Duloxetine 30mg orally and 200 ml of normal saline. |
| Control group | Placebo comparator | Drug: Placebo and normal salinePatients received a placebo capsule and an intravenous infusion of 200 mL of normal saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age from 18 to 65 years old.
- American Society of Anesthesiologists (ASA) physical I-II
- Scheduled for modified radical mastectomy (MRM) under general anesthesia.
Key exclusion criteria (4 listed)
- Liver or kidney disease
- Patient with previous chronic pain on opioids
- Patients on antidepressants and antipsychotics.
- Allergies to study drugs
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 |
|---|---|---|
| Magnesium sulphate and DuloxetineAlso: magnesium and cymbaltaPatients received Duloxetine 30mg orally and an intravenous infusion of magnesium sulphate 50mg/kg mixed with 200 ml of normal saline. | Drug | DM group |
| DuloxetineAlso: cymbaltaPatients received Duloxetine 30mg orally and 200 ml of normal saline. | Drug | D group |
| Placebo and normal salineAlso: placeboPatients received a placebo capsule and an intravenous infusion of 200 mL of normal saline. | Drug | Control group |
Primary outcome
Time to first analgesic request
Time frame: 48 hours postoperatively
Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administared).
5 secondary outcomes
Total morphine consumption
Time frame: 48 hours postoperatively
Degree of pain
Time frame: 48 hours postoperatively
Incidence of post-mastectomy pain syndrome
Time frame: 12 weeks postoperatively
Degree of patient satisfaction
Time frame: 48 hours postoperatively
Incidence of adverse events
Time frame: at 8 weeks postoperative and 12 weeks postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Duloxetine
RecruitingPhase 2
Duloxetine in Inflammatory Bowel Diseases
Inflammatory Bowel Diseases
Not yet recruitingPhase 2
Perineural Botulinum Toxin Injection Versus Oral Duloxetine in Relief of Foot Pain in Painful Peripheral Diabetic Neuropathy
Diabetic Peripheral Neuropathy, Painful Diabetic Neuropathy
RecruitingObservational study
Duloxetine Metabolism and Fibromyalgia
Fibromyalgia, Duloxetine
Not yet recruiting
Effects of 2-Aticyto Complex and D-Ribose on Pain and Clinical Course in Patients With Fibromyalgia
Fibromyalgia Syndrome, Fibromyalgia
RecruitingPhase 2
SPENDD: Quantitative Sensory Testing and Analgesic Response for Painful Peripheral Neuropathy.
Painful Peripheral Neuropathy, Diabetic Peripheral Neuropathic Pain (DPN)
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.
Ahmed s abdelgalil, MD principal investigator
assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium sulphate and Duloxetine and Duloxetine in people with Duloxetine and Magnesium Sulphate, run by National Cancer Institute, Egypt 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 5 Aug 2025. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first analgesic request (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 5 Aug 2025.