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

May 6, 2026 updated by: Subas Ali, Sindh Institute of Urology and Transplantation

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

158

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Karachi, Pakistan
        • Sindh Institute of urology and Transplantation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pregabalin
1 tablet of 75 mg administered once daily at night for 14 days without interruption
Drug: Pregabalin
1 tablet of 75 mg taken orally, once daily at night for 14 days, without interruption.
Active Comparator: acetominophen
1g of acetaminophen is administered thrice daily for 14 days without interruption
Drug: Acetaminophen
2 tablets of 500mg, taken orally, three times a day, 8 hours apart, for 14 days, without interruption.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 2 weeks
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.
Baseline and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sindh Institute of Urology and Transplantation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2024

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

May 15, 2026

Study Registration Dates

First Submitted

April 28, 2026

First Submitted That Met QC Criteria

April 28, 2026

First Posted (Actual)

May 5, 2026

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIUT-ERC-2024/A-475

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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