Adding Amantadine or Duloxetine to Pregabalin on Occurrence of Post Mastectomy Pain Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pregabalin, Pregabalin + Amantadine, Pregabalin + Duloxetine.
- Who it may be relevant to
- Registry conditions: Amantadine, Duloxetine, Pregabalin, Mastectomy. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Adding Amantadine or Duloxetine to Pregabalin on Occurrence of Post Mastectomy Pain Syndrome; Randomized Controlled Study
Overview
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.
Interventions
- Drug Pregabalin
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 + Amantadine
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 + Duloxetine
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.
Primary outcome measures
- The rate of occurrence of post mastectomy pain syndrome [Time frame: 12 weeks post-procedure]
Secondary outcome measures (8)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Cairo University — Cairo
Identifiers
NCT: NCT07421427 · AP2511-201-211-204