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Testing two pain relief patches for better recovery after lower limb bone surgeries

Efficacy of Buprenorphine and Fentanyl transdermal patches in managing postoperative pain following lower limb orthopaedic surgeries - A double blinded randomised controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092972
Enrollment
60
Registered
2025-08-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: M848- Other disorders of continuity of bone

Interventions

Intervention1: Buprenorphine transdermal patch 10 mcg/hour: Comparing pain relief satisfaction using buprenorphine transdermal patch through VAS score, Ramsay sedation score, time for rescue analgesia

Sponsors

Lokeshwar Vijayakumar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA 1 and 2 patients 2. Patients with BMI of more than 25 3. Patients scheduled for elective lower lib surgeries and who have given consent for the study 4. Age group 18 to 65 years

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1. ASA physical status of more than 3 2. Patients posted for emergency surgeries 3. Patients with history of allergy to study drugs 4. Pregnant and lactating woman 5. Patients with impaired pulmonary function 6. Patients with opioid intolerance

Design outcomes

Primary

MeasureTime frame
1. Postoperative Pain Level Measurement Method: Visual Analog Scale (VAS), scored from 1 (no pain) to 10 (severe pain). Timepoint: Post surgery 6 hours 12 hours 24 hours 48 hours 72 hours

Secondary

MeasureTime frame
2. Sedation Levels Measurement Method: Ramsay Sedation Score (scale: 1 to 5). 3. Time to Rescue Analgesia Time in hours until the first dose of rescue analgesia (diclofenac 75 mg IV). 4. Adverse Effects Observation of opioid-related side effects (e.g., nausea, vomiting, pruritus). Timepoint: Post surgery 6 hours 12 hours 24 hours 48 hours 72 hours

Countries

India

Contacts

Public ContactPrasanna Kumar

Sri Lalithambigai medical college and Hospital

prasan1092@gmail.com9751898045

Outcome results

None listed

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