Health Condition 1: null- Ca Breast,ASA I/II,Post chemotherapy patients,for unilateral non-reconstructive breast surgeries like modified radical mastectomy,simple mastectomy with axillary clearance,breast conservation surgery
Conditions
Interventions
Intervention1: Oral Paracetamol, pregabalin, etoricoxib and dexamethasone: Paracetamol 1 gm, pregabalin 75, etoricoxib 90 mg and dexamethasone 8 mg
Control Intervention1: four placebo drugs: Placebo d
Sponsors
Parmanand N Jain
Eligibility
Inclusion criteria
Inclusion criteria: 1.ASA I/ ASA II patients 2.Post chemotherapy patients, posted for 3.unilateral non-reconstructive breast surgeries like modified radical mastectomy,simple mastectomy with axillary clearance, breast conservation surgery. 4.Age group of 20-65 yrs
Exclusion criteria
Exclusion criteria: 1.Diabetic patients 2. ASA- III, ASA- IV patients 3. Below 20 yrs& Beyond 70yrs of age 4. Patients having preoperative pain 5. Patients undergoing reconstructive surgeries like latisimusdorsi flap, deep inferior epigastric free flap, gracilis flap 6. Patients with deranged liver function tests or kidney function tests 7. Hypersensitivity to paracetamol/etoricoxib/ pregabalin/ dexamethasone,Pregnant, nursing or geriatric patients,Active peptic ulceration or active gastro-intestinal (GI) bleeding,Patients taking aspirin tablets on a daily basis 8. Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneuroticoedema, urticaria, or allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors,Inflammatory bowel disease,Congestive heart failure (NYHA II-IV),Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease 9. Patients with psychological disorders,Uncontrolled infections, Systemic fungal infection,Concurrent treatment with live virus vaccines,A history of epilepsy,Alcohol, drug or both abuse,A daily intake of analgesics, except for non-steroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase-2 inhibitors or paracetamol 10. Patients enrolled for the EXERCISE study and VGSC study under DMG Breast Unit, Tata Memorial Centre.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess meanpain scores in patients receiving preoperative paracetamol dexamethasone etoricoxib and pregabalin during immediate postoperative period in patients undergoing unilateral non-reconstructive breast surgeriesTimepoint: Immediate post operative 2 hours 4 hours 24 hours 36 hours 1 week 1 month 3 months after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| To measure other side effects like nausea vomiting dizziness sedation respiratory depression constipation in the immediate post operative period and assessment of mean pain scores around the scar siteTimepoint: nausea vomiting Immediate post operative 2 hours 4 hours 24 hours 36 hours dizziness sedation nausea vomiting and others Immediate post operative 2 hours 4 hours 24 hours 36 hours 1 week 1 month 3 months after surgery | — |
Countries
India
Contacts
Public ContactParmanand N Jain
Tata Memorial Centre Mumbai
Outcome results
None listed