To Evaluate The Effectiveness of four painkillers for pain after breast removal surgery

Not Applicable

Recruiting

• Conditions: 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

• Registration Number: CTRI/2016/05/006926
• Lead Sponsor: Parmanand N Jain

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 82

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 <br/ ><br>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