Which trans-dermal patch ensures better pain relief after knee and hip replacement surgeries ? Buprenorphine versus Ketprophen, a Randomized control trial.
Phase 2
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2022/12/048057
- Lead Sponsor
- A.I.I.M.S, New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
a) Patients aged between 18 and 85years, scheduled to undergo a total hip or knee arthroplasty
b) ASA grade Iâ??III
c) No intra-articular procedures within the previous three months
d) No previous knee or hip procedures
Exclusion Criteria
a) Allergies to opioids or NSAIDs
b) Subjects who will refuse enrolment or later request removal from the study.
c) Patients with contraindications for regional anaesthesia.
d) Pain and/or disability at any other site
e) BMI >40
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) VAS score (during rest and activity) <br/ ><br>2) Oxford knee and hip scoresTimepoint: 1) VAS score (range; 0 to 10) is to be obtained both prior to surgery and post-operatively. <br/ ><br> <br/ ><br> VAS at rest will be obtained pre-operatively at rest and activity. <br/ ><br> <br/ ><br>VAS score will b obtained post-operatively at 2h , 6h, 12h, 24h ,48 h; 3rd, 5th, and 14th day; and VAS at activity will be obtained at 24h, 48h; 3rd, 5th and 14th day following surgery. <br/ ><br> <br/ ><br>2) Oxford knee and hip scores used for pre-operative evaluation; and on Post operative day 2, 5, and 14.
- Secondary Outcome Measures
Name Time Method 1.Adverse events (AEs)Timepoint: recorded within 14 days post-operatively.;2.Duration of hospital staysTimepoint: calculated by measuring the time from the completion of surgery through discharge for each patient;3.Patient satisfactionTimepoint: Subjects are asked to give a verbal assessment representative of the quality of analgesia at 24 and 48hours postoperatively. Response to this assessment is recorded as â??satisfiedâ??â?? or â??unsatisfied;4.Rescue analgesic useTimepoint: within the ï¬?rst 24 hours