Which trans-dermal patch ensures better pain relief after knee and hip replacement surgeries ? Buprenorphine versus Ketprophen, a Randomized control trial.

A randomized controlled trial: Transdermal buprenorphine versus ketoprofen patch for post-operative pain management after total knee and hip arthroplasty

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/12/048057

Enrollment

Registered

2022-12-13

Start date

Unknown

Completion date

Unknown

Last updated

2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Transdermal Buprenorphine patch: Buprenorphine transdermal patch- 10mg to be given on one day prior to surgery and to be continued 14 days after surgery Control Intervention1: Ketoprofe

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1) VAS score (during rest and activity) 2) Oxford knee and hip scoresTimepoint: 1) VAS score (range; 0 to 10) is to be obtained both prior to surgery and post-operatively. VAS at rest will be obtained pre-operatively at rest and activity. 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. 2) Oxford knee and hip scores used for pre-operative evaluation; and on Post operative day 2, 5, and 14.	—

Measure

Time frame

1) VAS score (during rest and activity) 2) Oxford knee and hip scoresTimepoint: 1) VAS score (range; 0 to 10) is to be obtained both prior to surgery and post-operatively. VAS at rest will be obtained pre-operatively at rest and activity. 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. 2) Oxford knee and hip scores used for pre-operative evaluation; and on Post operative day 2, 5, and 14.

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactDr Vijay Kumar

All India Institute of Medical Sciences, New Delhi

vijayaiims@yahoo.com9868037565

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026