Amantadine, Post-thoracotomy Pain Syndrome, Pregabalin
Conditions
Brief summary
This study aims to evaluate the additive effect of Amantadine to Pregabaline in the development of post-thoracotomy pain syndrome.
Detailed description
Lung cancer is still the most common cause of cancer-related deaths, and lung resection surgeries could be the primary therapeutic option. Hence, the number of thoracotomy procedures is progressively increasing, as well as the development of post-thoracotomy pain syndrome (PTPS). 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. Amantadine (1-aminoadamantane) is NMDA receptor antagonists. NMDA receptors were found to have role in the development of central sensitization, acute opioid tolerance, and opioid induced hyperalgesia.
Interventions
DRUGAmantadine+ Pregabalin
Two hours preoperative, patient will receive two capsules, one of them is Amantadine (Amantadine Hydrochloride) 100 mg and the other is Pregabalin (Lyrica) 75 mg and continued on both of them twice daily for 5 days postoperative.
DRUGPregabalin
Two hours preoperative, the patient will receive two capsules, one of them is pregabalin 75 mg, and the other is a placebo capsule similar to the amantadine capsule and continued on both of them twice daily for 5 days postoperative.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age (18-65) years. * Both sexes. * American Society of Anesthesiologists (ASA) Physical status II, III. * Body mass index (BMI): (20-40) kg/m2. * Cancer patients undergoing posterolateral thoracotomy incision for cancer lung, mesothelioma or other lung resection procedures.
Exclusion criteria
* 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. * Patient refusal. * Severe respiratory or cardiac disorders. * Advanced liver or kidney disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of occurrence of post-thoracotomy pain syndrome | 12 weeks postoperatively | Incidence of occurrence of post-thoracotomy pain syndrome at 12 weeks through 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 activity level | 12 weeks postoperatively | Postoperative Patient's activity level according to 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 |
| Total amount of morphine consumption | 48 hours postoperatively | Rescue analgesia will be provided in the form of intravenous morphine 3 mg boluses if the patient indicates Visual Analogue Scale (VAS) ≥ 4. |
| Patient's Quality of life | 12 weeks postoperatively | Patient's Quality of life according to Flanagan Quality of Life Scale (QOLS) which is a 16-item (domain) questionnaire with each item scored from 1 to 7 points. Participants respond to the questions using a seven-point Likert scale, ranging from 1 (completely dissatisfied) to 7 (delighted). 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, and 12. |
| Patient Global Impression of Change (PGIC) | 12 weeks postoperatively | Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. PGIC is a 7-point scale depicting a patient's rating of overall improvement. 0 (very much worse to 7 (very much improved). |
| Incidence of side effects of Pregabalin | 12 weeks postoperatively | Side effects of Pregabalin such as headaches, feeling sleepy, tired or dizzy, diarrhoea, mood changes, feeling sick, swollen hands, arms, legs and feet, blurred vision, difficulties with getting an erection, and weight gain - because pregabalin can cause you feel hungry, and memory problems will be recorded. |
| Total amount of fentanyl consumption | Intraoperatively | Rescue analgesia of fentanyl 1 μg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels. |
Countries
Egypt
Outcome results
None listed