Comparison Between Pregabalin and Acetaminophen for the Treatment of Post-Mastectomy Pain Syndrome (NCT07567924) | Clinical Trial Compass
CompletedPhase 4
Comparison Between Pregabalin and Acetaminophen for the Treatment of Post-Mastectomy Pain Syndrome
Pakistan158 participantsStarted 2024-02-06
Plain-language summary
The goal of this trial is to learn if Pregabalin is better than Acetaminophen in pain management of patients with Post-Mastectomy pain Syndrome, which is defined as pain in the scar, chest wall, shoulder after undergoing mastectomy or breast-conservation (BCS). It could be burning, stabbing, shooting pain or pins-and-needle sensation.
Participants will:
* Take their prescribed allotted medicine for 14 days.
* Will visit the clinic at 2 and 6 week interval for assessment.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All diagnosed cases of post mastectomy pain syndrome
* Patients developing radiation dermatitis grade 0 and 1
Exclusion Criteria:
* Patient undergoing toilet mastectomy
* Patient developing radiation dermatitis grade 2, 3 and 4
* Patients with convulsions
* Patients with known pregabalin hypersensitivity (lightheadedness , sedation , double vision ,increase in bodyweight and imbalance)
* Patients with known acetaminophen hypersensitivity (urticaria, bronchospasm, anaphylaxis)
* Patients with renal failure
* Patients with hepatic dysfunction/ hepatic disease
* Patients with prior use of pregabalin due to chronic pain conditions within 3 months
* Pregnant or lactating
* Neuropsychiatric disorders
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared pregabalin to acetaminophen for post-mastectomy pain syndrome — based on the results, which of these two treatments do you think would be a better fit for managing my specific pain?
2Since this was a Phase 4 trial, both medications are already approved and have established safety profiles — does that mean we have a clearer picture of the risks compared to earlier-phase studies, and how does that affect your recommendation for me?
3The trial measured pain relief at 2 weeks and 6 weeks using a visual analogue score — do you know whether either medication showed meaningful improvement at those time points, and what that might realistically mean for my day-to-day pain?
4Are there reasons I might not be a good candidate for pregabalin specifically, such as concerns about dizziness, weight gain, or interactions with other medications I'm already taking?
5Before considering either of these medications, is there a standard first-line treatment for post-mastectomy pain syndrome that I should try first, or would it make sense to discuss one of the options from this trial right away?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in the Visual Analogue Score at 2 weeks
Timeframe: Baseline and 2 weeks
2
Change from Baseline in the Visual Analogue Score at 6 weeks