Effectiveness of Buprenorphine Patch applied on skin for post-operative pain in patients undergoing Knee Replacement surgeries.
Phase 2
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2024/05/066648
- Lead Sponsor
- Dr Katta Vani
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Patients undergoing Total Knee Replacement surgery under Spinal Anaesthesia.
2. American Society Of Anesthesiologists (ASA) physical status I and II.
3. 18 - 70 years of age of either gender.
Exclusion Criteria
1. Allergy to Buprenorphine
2. Opioid dependency for more than 3 months
3. Alcoholic Liver Disease, Chronic Kidney Disease 4 and 5
4. Pregnant women
5. Malignancy
6. Patient on any anti-depressants (or) anti-convulsant
7. Morbidly Obese (BMI more than 35)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total doses of post-operative rescue analgesia requirement.Timepoint: Up to 72 hours post-operatively.
- Secondary Outcome Measures
Name Time Method 1. Pain Score by 11-Point Numerical Rating Scale (NRS) at 8th, 24th, 48th and 72nd hours post-operatively. <br/ ><br>2. Sedation Score by Ramsay Sedation Score (RSS) at 8th, 24th, 48th and 72nd hours post-operatively. <br/ ><br>3. Incidence of adverse effects like Post-Operative Nausea and Vomiting (PONV), Pruritus, Respiratory Depression and Urinary Retention. <br/ ><br>4. Hemodynamic Variations like Mean Arterial Pressure (MAP) and Heart Rate (HR). <br/ ><br>5. Quality of Recovery Index is calculated based on 15 questions each carrying 0-10 points totalling up to 0-150 and patients are divided into poor, moderate, good and excellent recovery for 0-89, 90-121, 122-135 and 136-150 respectively at 24th, 48th and 72nd hours.Timepoint: 1. 11-Point Numerical Rating Scale and Ramsay Sedation Scale score at 8th, 24th, 48th and 72nd hour. <br/ ><br>2. Quality of Recovery Index at 24th, 48th and 72nd hours.