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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07567924

Enrollment

158

Registered

2026-05-05

Start date

2024-02-06

Completion date

2026-05-15

Last updated

2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Mastectomy Pain Syndrome

Keywords

Post mastectomy pain syndrome, PMPS, Pregabalin, Acetaminophen, Visual Analogue Score

Brief 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.

Interventions

DRUGPregabalin

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

DRUGAcetaminophen

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

The person analyzing the data will be blinded to allocation.

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change from Baseline in the Visual Analogue Score at 2 weeks	Baseline and 2 weeks	Zero is equivalent to no pain, and 10 indicates the worst possible pain.
Change from Baseline in the Visual Analogue Score at 6 weeks	Baseline and 6 weeks	Zero is equivalent to no pain, and 10 indicates the worst possible pain.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 5, 2026