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Completed

NCT Number: NCT07567924

Comparison Between Pregabalin and Acetaminophen for the Treatment of Post-Mastectomy Pain Syndrome

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.

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Key information

Conditions

Post Mastectomy Pain Syndrome

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Sindh Institute of urology and Transplantation

Karachi, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pregabalin

Drug

1 tablet of 75 mg taken orally, once daily at night for 14 days, without interruption.

Acetaminophen

Drug

2 tablets of 500mg, taken orally, three times a day, 8 hours apart, for 14 days, without interruption.

Primary outcomes

  1. Change from Baseline in the Visual Analogue Score at 2 weeks

    Time frame: Baseline and 2 weeks

    Zero is equivalent to no pain, and 10 indicates the worst possible pain.

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

    Time frame: Baseline and 6 weeks

    Zero is equivalent to no pain, and 10 indicates the worst possible pain.

Sponsors and collaborators

Lead sponsor

Subas Ali

Other

Collaborators

  • Sindh Institute of Urology and Transplantation

Registry information

Official study title

A Comparison Between Pregabalin and Acetaminophen for the Treatment of Post-Mastectomy Pain Syndrome: A Single-blinded Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 5, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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