Amantadine, Duloxetine, Mastectomy, Pain Syndrome, Pregabalin
Conditions
Brief summary
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
DRUGPregabalin
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
DRUGPregabalin + 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.
DRUGPregabalin + 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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of occurrence of post mastectomy pain syndrome | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient's Quality of life | 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. |
| Patient's activity level | 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. |
| Degree of pain | 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"). |
| Total amount of fentanyl | Intraoperatively | Total amount of fentanyl consumed intraoperative will be recorded. |
| Total amount of morphine consumption | 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. |
| Incidence of side effects related to Amantadine | 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. |
| Incidence of side effects related to Pregabalin | 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. |
| Incidence of side effects related to duloxetine | 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. |
Countries
Egypt
Contacts
CONTACTHossam H Sayed, MSc
Outcome results
None listed