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Comparison of Transdermal Buprenorphine and Diclofenac patch for post operative pain relief in patients undergoing major lower limb orthopaedic surgeries

Comparison of effectiveness between Transdermal Buprenorphine and Diclofenac patch for post operative analgesia in major orthopaedic lower limb surgeries under spinal anaesthesia: prospective double blinded randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/08/035857
Enrollment
50
Registered
2021-08-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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 5 MICROGRAMS: TRANSDERMAL BUPRENORPHINE PATCH 5 MICROGRAMS GIVEN 30 MINUTES PRIOR TO SURGERY Control Intervention1: TRANSDERMAL DICLOFENAC PATCH 100 GRAM

Sponsors

GOVERNMENT MEDICAL COLLEGE BHAVNAGAR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Elective and emergency orthopaedic surgery patients with lower limb long bone fractures 2.Age group:18-60 years 3.ASA grade I- III

Exclusion criteria

Exclusion criteria: 1.Patients having injuries over other parts of body rather than lower limb 2.Altered coagulation profile and spinal deformities(Kyphosis, Scoliosis) 3.Suffering from respiratory disease, severe hepatic and renal dysfunction 4.Pregnant and lactating mother 5.Hypersensitivity to study drugs

Design outcomes

Primary

MeasureTime frame
1.To compare the post-operative analgesia by visual analogue scale between both groups 2.To compare frequency of need for rescue analgesia between both groups Timepoint: 24 HOURS—

Secondary

MeasureTime frame
1.To compare change in pulse rate, mean arterial pressure, Spo2, respiratory rate between both groups. 2.To compare the proportion of post-operative nausea, vomiting, PruritiS between both groups Timepoint: 24 HOURS—

Countries

India

Contacts

Public ContactDr PAMPANA BHUVAN CHANDRA KANTH

Government medical college, Bhavnagar

shah.komal212@gmail.com9427215252

Outcome results

None listed

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