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

NCT07567924 | Active Not Recruiting Phase 4

• 1 other identifier: SIUT-ERC-2024/A-475
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Mastectomy Pain Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

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

  Baseline and 6 weeks

Study Arms (2)

Pregabalin

EXPERIMENTAL

1 tablet of 75 mg administered once daily at night for 14 days without interruption

Drug: Pregabalin

acetominophen

ACTIVE COMPARATOR

1g of acetaminophen is administered thrice daily for 14 days without interruption

Drug: Acetaminophen

Interventions

Pregabalin DRUG

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

Pregabalin

Acetaminophen DRUG

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

acetominophen

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All diagnosed cases of post mastectomy pain syndrome
• Patients developing radiation dermatitis grade 0 and 1

You may not qualify if:

• 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

Sponsors & Collaborators

• Sindh Institute of Urology and Transplantation: lead

Study Sites (1)

Sindh Institute of urology and Transplantation

Karachi, Pakistan

Location

MeSH Terms

Interventions

Pregabalin; Acetaminophen

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The person analyzing the data will be blinded to allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Registrar

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 5, 2026
• Study Start: February 6, 2024
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)