Amantadine or duloxetine added to pregabalin to prevent post-mastectomy pain
Official title: The Effect of Adding Amantadine or Duloxetine to Pregabalin on Occurrence of Post Mastectomy Pain Syndrome; Randomized Controlled Study
Run by Cairo University · NCT07421427 · Data updated 2026-11-12
This will see if adding amantadine or duloxetine to pregabalin around the time of modified radical mastectomy reduces the risk of long-term post-mastectomy pain in adults aged 18–65.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | Women only |
| Enrollment | 150 (estimated) |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Status | Recruiting |
| Started | February 21, 2026 |
| Main results expected | January 1, 2027 |
| Study ends | January 1, 2027 |
| Registry record updated | February 24, 2026 |
| Trial ID | NCT07421427 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–65 undergoing modified radical mastectomy with ASA II–III status and BMI 20–40 who have not used antidepressants, anticonvulsants, or opioids before surgery are the intended participants.
✕Probably not a fit
Patients with contraindications to the study drugs, severe cardiac/respiratory/hepatic/renal disease, prior breast surgery, or a history of chronic pain or psychiatric disorder are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Post-mastectomy pain syndrome (PMPS) is a common chronic pain condition after breast surgery. This interventional, three-arm study compares pregabalin alone versus pregabalin plus amantadine versus pregabalin plus duloxetine in patients undergoing modified radical mastectomy. Eligible adults (18–65, ASA II–III, BMI 20–40) without prior antidepressant/anticonvulsant/opioid use or previous breast surgery are enrolled, and those with major organ disease or psychiatric history are excluded. The primary outcome is the occurrence of PMPS after surgery, comparing rates between the three treatment groups.
Why it matters
Potential benefit: If successful, adding one of these drugs to pregabalin could lower the number of patients who develop chronic post-mastectomy pain and improve long-term comfort.
How similar studies have gone: Previous work shows pregabalin and duloxetine can reduce some chronic postoperative and neuropathic pain, while evidence for amantadine (an NMDA antagonist) in preventing chronic post-surgical pain is limited and mixed.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age from 18 to 65 years. * American society of anesthesiologists (ASA) Physical status II, III. * Body mass index (BMI): (20-40) kg/m2. * Type of surgery: patients undergoing modified radical mastectomy for breast cancer. Exclusion Criteria: * Patient refusal. * Patients with Known sensitivity or contraindication to drug used in the study. * History of psychological disorders and/or chronic pain and drug abuse patients. * Previous administration of antidepressants, anticonvulsants, or opioids before surgery. * Severe respiratory or cardiac disorders. * Advanced liver or kidney disease. * Previous breast surgery
Where it's running
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Cairo University
Cairo, Egypt Recruiting
Study contacts
- Study coordinator: Hossam H Sayed, MSc
- Email: hussamhassan90@gmail.com
- Phone: 00201144692302
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.