AmantadineNCT07421427
Adding Amantadine or Duloxetine to Pregabalin on Occurrence of Post Mastectomy Pain Syndrome
A study testing Pregabalin, Pregabalin + Amantadine and Pregabalin + Duloxetine in people with Amantadine and Duloxetine, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to evaluate the additive effect of Amantadine or Duloxetine to Pregabalin on development of post mastectomy pain syndrome Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Amantadine, Duloxetine, Pregabalin
- What is being tested?
- Pregabalin, Pregabalin + Amantadine and Pregabalin + Duloxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Feb 2026to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 65 years.
- American society of anesthesiologists (ASA) Physical status II, III.
- Body mass index (BMI): (20-40) kg/m2.
- Type of surgery: patients undergoing modified radical mastectomy for breast cancer.
Who cannot join
- Patient refusal.
- Patients with Known sensitivity or contraindication to drug used in the study.
- History of psychological disorders and/or chronic pain and drug abuse patients.
- Previous administration of antidepressants, anticonvulsants, or opioids before surgery.
- Severe respiratory or cardiac disorders.
- Advanced liver or kidney disease.
- Previous breast surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 12613
Hossam H Sayed, MSc, 00201144692302, hussamhassan90@gmail.com
Raafat M Reyad, MD
About this study
Official title: The Effect of Adding Amantadine or Duloxetine to Pregabalin on Occurrence of Post Mastectomy Pain Syndrome; Randomized Controlled Study
This study aims to evaluate the additive effect of Amantadine or Duloxetine to Pregabalin on development of post mastectomy pain syndrome
Read the detailed description
Post mastectomy pain syndrome (PMPS) is considered one of the most common types of CPSP with incidence ranging between 20% - 50%.
Pregabalin is one of the drugs that can reduce the excitability of the dorsal horn neurons. It is a γ-aminobutyric acid analogue that binds to α2-δ subunits of the voltage-gated calcium channels in the central nervous system.
Duloxetine is an SNRI that increases serotonin and norepinephrine levels in the central nervous system, which helps modulate pain pathways. Originally developed for depression and anxiety, it is also used for chronic pain conditions such as fibromyalgia, diabetic neuropathy, and chronic musculoskeletal pain.
Amantadine is a noncompetitive antagonist of N-methyl-D-aspartate (NMDA) receptors. These receptors play a significant role in the development of central sensitization, acute opioid tolerance, and opioid-induced hyperalgesia.
- Conditions
- Amantadine, Duloxetine, Pregabalin, Mastectomy, Pain Syndrome
- Being tested
- Pregabalin, Pregabalin + Amantadine, Pregabalin + Duloxetine
- Medical subject headings
- Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Two hours preoperative patient will receive one capsule of Pregabalin 75 mg (Lyrica 75 mg, Viatris) and) and one placebo tablet and will continue on both of them twice daily for seven days postoperative
Pregabalin + AmantadineDrug
Two hours preoperative patient will receive one capsule of pregabalin 75 mg (Lyrica 75 mg, Viatris) and one tablet of Amantadine 100 mg (PK-Merz 100 mg, MERZ Pharma) and will continue on both twice daily for seven days postoperative.
Pregabalin + DuloxetineDrug
Two hours preoperative patient will receive one capsule of pregabalin 75 mg (Lyrica 75 mg, Viatris) and one capsule of Duloxetine 30 mg (Cymbatex 30 mg, EVA Pharma) and will continue on both twice daily for seven days postoperative.
| Study group | Role | What they receive |
|---|---|---|
| Group P (Pregabalin group) | Active comparator | Two hours preoperative patient will receive one capsule of Pregabalin 75 mg (Lyrica 75 mg, Viatris) and) and one placebo tablet and will continue on both of them twice daily for seven days postoperative. Receives: Drug: Pregabalin |
| Group PA (Pregabalin + Amantadine group) | Experimental | Two hours preoperative patient will receive one capsule of pregabalin 75 mg (Lyrica 75 mg, Viatris) and one tablet of Amantadine 100 mg (PK-Merz 100 mg, MERZ Pharma) and will continue on both twice daily for seven days postoperative. Receives: Drug: Pregabalin + Amantadine |
| Group PD (Pregabalin + Duloxetine group) | Experimental | Two hours preoperative patient will receive one capsule of pregabalin 75 mg (Lyrica 75 mg, Viatris) and one capsule of Duloxetine 30 mg (Cymbatex 30 mg, EVA Pharma) and will continue on both twice daily for seven days postoperative. Receives: Drug: Pregabalin + Duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of occurrence of post mastectomy pain syndrome
The rate of occurrence of post mastectomy pain syndrome will be recorded according to Grading system for neuropathic pain (GSNP). GSNP is as follows: Grade 1 (unlikely), Grade 2 (possible), Grade 3 (probable), and Grade 4 (definite), the patients will be considered positive regarding incidence being in grade 3 or 4.
Measured: 12 weeks post-procedure
Secondary outcomes (8)
Patient's Quality of life
Patient's Quality of life will be assessed using Flanagan Quality of Life Scale (QOLS) which is a 16-item (domain) questionnaire with each item scored from 1 to 7 points. The scale will be explained to the patients and the total score will be calculated and recorded at the preoperative assessment (baseline) and at postoperative weeks 2, 4, 8,12.
Measured: 12 weeks post-procedure
Patient's activity level
Postoperative patient's activity level will be assessed using Barthel Activities of Daily Living scale (ADL). This scale comprises 10 basic daily activities (bowel, bladder, feeding, toilet, bathing, dressing, grooming, walking, stairs and transfer) with each item scored as 0 = need complete help, 1 = need some help or 2 = need no help.
Measured: 12 weeks post-procedure
Degree of pain
Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS). NRS (0 represents "no pain" while 10 represents "the worst pain imaginable").
Measured: 12 weeks post-procedure
Total amount of fentanyl
Total amount of fentanyl consumed intraoperative will be recorded.
Measured: Intraoperatively
Total amount of morphine consumption
Rescue analgesia will be provided in the form of IV morphine 3 mg boluses if the patient indicates numeric rating scale (NRS)≥ 4.
Measured: 48 hours post-procedure
Incidence of side effects related to Pregabalin
Incidence of side effects related to Pregabalin such as headaches, feeling sleepy, tired or dizzy, diarrhea, mood changes, swollen hands, arms, legs and feet, blurred vision, erectile dysfunction, weight gain, and memory problems will be recorded.
Measured: 48 hours post-procedure
Incidence of side effects related to Amantadine
Incidence of side effects related to Amantadine such as dry mouth, constipation, nausea, vomiting, decreased appetite, difficulty falling asleep or staying asleep, abnormal dreams, headache, confusion, drowsiness, tiredness, uncontrollable tightening of muscles, and lace-like purple pattern on skin will be recorded.
Measured: 48 hours post-procedure
Incidence of side effects related to duloxetine
Incidence of side effects related to duloxetine such as dry mouth, constipation, loss of appetite, fatigue, drowsiness, or increased sweating. Some people may experience dizziness, headache, or insomnia will be recoded.
Measured: 48 hours post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start21 Feb 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmantadineStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hussam Hassan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421427
- Sponsor's protocol ID
- AP2511-201-211-204
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adding Amantadine or Duloxetine to Pregabalin on Occurrence of Post Mastectomy Pain Syndrome; Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07421427
- Acronym / sponsor ID
- AP2511-201-211-204
- Conditions
- Amantadine, Duloxetine, Pregabalin, Mastectomy, Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 21 Feb 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 19 Feb 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.
This study aims to evaluate the additive effect of Amantadine or Duloxetine to Pregabalin on development of post mastectomy pain syndrome
Detailed description
Post mastectomy pain syndrome (PMPS) is considered one of the most common types of CPSP with incidence ranging between 20% - 50%.
Pregabalin is one of the drugs that can reduce the excitability of the dorsal horn neurons. It is a γ-aminobutyric acid analogue that binds to α2-δ subunits of the voltage-gated calcium channels in the central nervous system.
Duloxetine is an SNRI that increases serotonin and norepinephrine levels in the central nervous system, which helps modulate pain pathways. Originally developed for depression and anxiety, it is also used for chronic pain conditions such as fibromyalgia, diabetic neuropathy, and chronic musculoskeletal pain.
Amantadine is a noncompetitive antagonist of N-methyl-D-aspartate (NMDA) receptors. These receptors play a significant role in the development of central sensitization, acute opioid tolerance, and opioid-induced hyperalgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group P (Pregabalin group) | Active comparator | Drug: PregabalinTwo hours preoperative patient will receive one capsule of Pregabalin 75 mg (Lyrica 75 mg, Viatris) and) and one placebo tablet and will continue on both of them twice daily for seven days postoperative. |
| Group PA (Pregabalin + Amantadine group) | Experimental | Drug: Pregabalin + AmantadineTwo hours preoperative patient will receive one capsule of pregabalin 75 mg (Lyrica 75 mg, Viatris) and one tablet of Amantadine 100 mg (PK-Merz 100 mg, MERZ Pharma) and will continue on both twice daily for seven days postoperative. |
| Group PD (Pregabalin + Duloxetine group) | Experimental | Drug: Pregabalin + DuloxetineTwo hours preoperative patient will receive one capsule of pregabalin 75 mg (Lyrica 75 mg, Viatris) and one capsule of Duloxetine 30 mg (Cymbatex 30 mg, EVA Pharma) and will continue on both twice daily for seven days postoperative. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 18 to 65 years.
- American society of anesthesiologists (ASA) Physical status II, III.
- Body mass index (BMI): (20-40) kg/m2.
- Type of surgery: patients undergoing modified radical mastectomy for breast cancer.
Key exclusion criteria (7 listed)
- Patient refusal.
- Patients with Known sensitivity or contraindication to drug used in the study.
- History of psychological disorders and/or chronic pain and drug abuse patients.
- Previous administration of antidepressants, anticonvulsants, or opioids before surgery.
- Severe respiratory or cardiac disorders.
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 |
|---|---|---|
| PregabalinTwo hours preoperative patient will receive one capsule of Pregabalin 75 mg (Lyrica 75 mg, Viatris) and) and one placebo tablet and will continue on both of them twice daily for seven days postoperative | Drug | Group P (Pregabalin group) |
| Pregabalin + AmantadineTwo hours preoperative patient will receive one capsule of pregabalin 75 mg (Lyrica 75 mg, Viatris) and one tablet of Amantadine 100 mg (PK-Merz 100 mg, MERZ Pharma) and will continue on both twice daily for seven days postoperative. | Drug | Group PA (Pregabalin + Amantadine group) |
| Pregabalin + DuloxetineTwo hours preoperative patient will receive one capsule of pregabalin 75 mg (Lyrica 75 mg, Viatris) and one capsule of Duloxetine 30 mg (Cymbatex 30 mg, EVA Pharma) and will continue on both twice daily for seven days postoperative. | Drug | Group PD (Pregabalin + Duloxetine group) |
Primary outcome
The rate of occurrence of post mastectomy pain syndrome
Time frame: 12 weeks post-procedure
The rate of occurrence of post mastectomy pain syndrome will be recorded according to Grading system for neuropathic pain (GSNP). GSNP is as follows: Grade 1 (unlikely), Grade 2 (possible), Grade 3 (probable), and Grade 4 (definite), the patients will be considered positive regarding incidence being in grade 3 or 4.
8 secondary outcomes
Patient's Quality of life
Time frame: 12 weeks post-procedure
Patient's activity level
Time frame: 12 weeks post-procedure
Degree of pain
Time frame: 12 weeks post-procedure
Total amount of fentanyl
Time frame: Intraoperatively
Total amount of morphine consumption
Time frame: 48 hours post-procedure
Incidence of side effects related to Pregabalin
Time frame: 48 hours post-procedure
Incidence of side effects related to Amantadine
Time frame: 48 hours post-procedure
Incidence of side effects related to duloxetine
Time frame: 48 hours post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pregabalin, Pregabalin + Amantadine and Pregabalin + Duloxetine in people with Amantadine and Duloxetine, run by Cairo University at 1 site in Egypt.
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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 24 Feb 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 Egypt. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hossam H Sayed, MSc (00201144692302, hussamhassan90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of occurrence of post mastectomy pain syndrome (time frame: 12 weeks post-procedure). 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 24 Feb 2026.