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postoperative analgesia in major gynecological surgery:buprenorphine transdermal patch with oral paracetamol compared to intramuscular diclofenac injection

Transdermal buprenorphine patch plus oral paracetamol vs intramuscular diclofenac for postoperative analgesia in major gynaecological surgeries - Randomised control trial - nil

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110537
Enrollment
150
Registered
2026-05-18
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: 8- Other Procedures

Interventions

Intervention1: TRANSDERMAL BUPRENORPHINE PATCH: Preoperative Preparation A transdermal buprenorphine patch (5 g/h) is applied to the upper outer arm of the patient approximately 12 h prior to surgery

Sponsors

S Nijalingappa medical college
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Female patients aged 20 50 years Undergoing major gynaecological surgery under general or regional anesthesia ASA physical status I or II Willing to give informed consent

Exclusion criteria

Exclusion criteria: Known allergy or hypersensitivity to buprenorphine, paracetamol, or diclofenac History of chronic pain or long-term opioid use Hepatic or renal dysfunction Severe cardiopulmonary illness Psychiatric illness or cognitive impairment Refusal to participate in the study

Design outcomes

Primary

MeasureTime frame
to evaluate and compare the safety and efficacy of transdermal buprenorphine patch plus paracetamol vs diclofenac injection in randomised gynaecological surgeries and the onset and duration of analgesia following major gynaecological surgeriesTimepoint: to check VAS score at 4 hours 12 hours 24 hours post op day 2 and post op day 3

Secondary

MeasureTime frame
The duration & efficacy of post operative analgesia defined by the time interval between the end of surgery & a Visual Analogue Scale VAS pain score more than 4Timepoint: to check VAS score at 4 hours 12 hours 24 hours post op day 2 & post op day 3

Countries

India

Contacts

Public ContactDr Nandashree R V

S Nijalingappa medical college and HSK hospital and research centre, Bagalkot

manohartankasali@gmail.com9886291099

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026