Adding Amantadine or Duloxetine to Pregabalin on Occurrence of Post Mastectomy Pain Syndrome

NCT07421427 | Recruiting

• 1 other identifier: AP2511-201-211-204
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the additive effect of Amantadine or Duloxetine to Pregabalin on development of post mastectomy pain syndrome

Conditions

Amantadine; Duloxetine; Pregabalin; Mastectomy; Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks post-procedure

Secondary Outcomes (8)

• Patient's Quality of life

  12 weeks post-procedure

• Patient's activity level

  12 weeks post-procedure

• Degree of pain

  12 weeks post-procedure

• Total amount of fentanyl

  Intraoperatively

• Total amount of morphine consumption

  48 hours post-procedure

Study Arms (3)

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.

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.

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.

Drug: Pregabalin + Duloxetine

Interventions

Pregabalin DRUG

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

Group P (Pregabalin group)

Pregabalin + Amantadine DRUG

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.

Group PA (Pregabalin + Amantadine group)

Pregabalin + Duloxetine DRUG

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.

Group PD (Pregabalin + Duloxetine group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Women undergoing modified radical mastectomy for breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

RECRUITING

MeSH Terms

Conditions

Somatoform Disorders

Interventions

Pregabalin; Amantadine; Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Thiophenes; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Hossam H Sayed, MSc

CONTACT

00201144692302; hussamhassan90@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesia, ICU and Pain Management, Cairo University, Cairo, Egypt.

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: February 21, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)