Post Mastectomy Pain SyndromePhase 4NCT07567924
Comparison Between Pregabalin and Acetaminophen for the Treatment of Post-Mastectomy Pain Syndrome
A Phase 4 study testing Pregabalin and Acetaminophen in people with Post Mastectomy Pain Syndrome, run by Subas Ali at 1 site in Pakistan.
Trial 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). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Post Mastectomy Pain Syndrome
- What is being tested?
- Pregabalin and Acetaminophen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Feb 2024to 15 May 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All diagnosed cases of post mastectomy pain syndrome
- Patients developing radiation dermatitis grade 0 and 1
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Post Mastectomy Pain Syndrome
- Being tested
- Pregabalin, Acetaminophen
- Keywords
- Post mastectomy pain syndrome, PMPS, Pregabalin, Acetaminophen, Visual Analogue Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
1 tablet of 75 mg taken orally, once daily at night for 14 days, without interruption.
AcetaminophenDrug
2 tablets of 500mg, taken orally, three times a day, 8 hours apart, for 14 days, without interruption.
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin | Experimental | 1 tablet of 75 mg administered once daily at night for 14 days without interruption Receives: Drug: Pregabalin |
| acetominophen | Active comparator | 1g of acetaminophen is administered thrice daily for 14 days without interruption Receives: Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Visual Analogue Score at 2 weeks
Zero is equivalent to no pain, and 10 indicates the worst possible pain.
Measured: Baseline and 2 weeks
Change from Baseline in the Visual Analogue Score at 6 weeks
Zero is equivalent to no pain, and 10 indicates the worst possible pain.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start6 Feb 2024
- Primary completion15 May 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Mastectomy Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Subas Ali
- Sponsor type
- University, hospital or other
- Collaborators
- Sindh Institute of Urology and Transplantation
- Responsible party
- Sponsor-investigator, Subas Ali, Sindh Institute of Urology and Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07567924
- Sponsor's protocol ID
- SIUT-ERC-2024/A-475
- Status last verified
- May 2026
- First submitted
- 28 Apr 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Pregabalin and Acetaminophen for the Treatment of Post-Mastectomy Pain Syndrome: A Single-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07567924
- Acronym / sponsor ID
- SIUT-ERC-2024/A-475
- Conditions
- Post Mastectomy Pain Syndrome
- Keywords
- Post mastectomy pain syndrome, PMPS, Pregabalin, Acetaminophen, Visual Analogue Score
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Subas AliUniversity, hospital or other
- Collaborators
- Sindh Institute of Urology and Transplantation
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin | Experimental | Drug: Pregabalin1 tablet of 75 mg administered once daily at night for 14 days without interruption |
| acetominophen | Active comparator | Drug: Acetaminophen1g of acetaminophen is administered thrice daily for 14 days without interruption |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All diagnosed cases of post mastectomy pain syndrome
- Patients developing radiation dermatitis grade 0 and 1
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pregabalin1 tablet of 75 mg taken orally, once daily at night for 14 days, without interruption. | Drug | Pregabalin |
| Acetaminophen2 tablets of 500mg, taken orally, three times a day, 8 hours apart, for 14 days, without interruption. | Drug | acetominophen |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregabalin and Acetaminophen in people with Post Mastectomy Pain Syndrome, run by Subas Ali at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Visual Analogue Score at 2 weeks (time frame: Baseline and 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.