NCT Number: NCT07421427
This study aims to evaluate the additive effect of Amantadine or Duloxetine to Pregabalin on development of post mastectomy pain syndrome
Interested in participating?
Request Info18 year–65 year
Female
Interventional
Not applicable
Cairo, 12613, Egypt
Location status: Recruiting
Ahmed S Mohammed, MD
SUB_INVESTIGATOR
Hossam H Sayed, MSc
CONTACT
Raafat M Reyad, MD
SUB_INVESTIGATOR
Reham M Gamal, MD
SUB_INVESTIGATOR
Salma Abd Elmooty, MD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
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.
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.
Time frame: 12 weeks post-procedure
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.
Time frame: 12 weeks post-procedure
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.
Time frame: 12 weeks post-procedure
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").
Time frame: Intraoperatively
Total amount of fentanyl consumed intraoperative will be recorded.
Time frame: 48 hours post-procedure
Rescue analgesia will be provided in the form of IV morphine 3 mg boluses if the patient indicates numeric rating scale (NRS)≥ 4.
Time frame: 48 hours post-procedure
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.
Time frame: 48 hours post-procedure
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.
Time frame: 48 hours post-procedure
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.
Contact information is provided by the study sponsor or research team.
Cairo University
Other
The Effect of Adding Amantadine or Duloxetine to Pregabalin on Occurrence of Post Mastectomy Pain Syndrome; Randomized Controlled Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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