Active — Not RecruitingPhase 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

SexFEMALE

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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

What they're measuring

Change from Baseline in the Visual Analogue Score at 2 and 6 weeks

Timeframe: Baseline and 6 weeks

Trial details

NCT IDNCT07567924

SponsorSindh Institute of Urology and Transplantation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-15

View on ClinicalTrials.gov More Post Mastectomy Pain Syndrome trials