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A clinical trial to study pain relief effects of two drugs, buprenorphine and fentanyl which are applied as patches below curved front bone of the shoulder in patients undergoing surgeries involving female reproductive system.

Comparative evaluation of transdermal buprenorphine and transdermal fentanyl for Postoperative Pain Relief after gynaecological Surgeries â?? a prospective randomized study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/06/043482
Enrollment
74
Registered
2022-06-24
Start date
Unknown
Completion date
Unknown
Last updated
2022-06-27

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

Conditions

Health Condition 1: N00-N99- Diseases of the genitourinary system Health Condition 2: N80-N98- Noninflammatory disorders of female genital tract

Interventions

Intervention1: Buprenorphine transdermal patch (20 mcg/hr): Buprenorphine transdermal patch at a dose of 20 mcg/hr will be applied over subclavian area for patients undergoing gynaecological surgeries

Sponsors

Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Women (Age-18 â?? 60 ). ASA classes I to III. Those posted for transabdominal gynecological surgeries performed with pfannenstiel incision.

Exclusion criteria

Exclusion criteria: History of allergy to opioids. History of ongoing drug/ alcohol abuse. Patients who are already using a transdermal opioid patch, dependence on opioids. Pregnant patients. Combined epidural block. Patients with abnormal liver or renal function.

Design outcomes

Primary

MeasureTime frame
To compare the postoperative analgesic efficacy between transdermal buprenorphine and transdermal fentanyl after gynecological surgeries using a visual analog scale (VAS) at rest and movement.Timepoint: Visual analog scale (VAS) at rest is recorded at postoperative period of 1st,1.5th,2nd,4th,6th,8th,10th,12th,16th,20th,24th,28th,32nd,36th,40th,44th,48th,72nd hours. Visual analog scale (VAS) at movement is recorded at postoperative period of 24th,28th,32nd,36th,40th,44th,48th,72nd hours.—

Secondary

MeasureTime frame
To compare hemodynamic variations such as heart rate (HR), Respiratory rate (RR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), oxygen saturation (SPO2) between the groups.Timepoint: preoperative period (baseline),postoperative period at 1st,1.5th,2nd,4th,6th,8th,10th,12th,16th,20th,24th,28th,32nd,36th,40th,44th,48th,72nd hours.;To compare the side effects between the groups.Timepoint: postoperative period from 1st to 72nd hours.;To compare the time to rescue analgesia between the groups.Timepoint: Postoperative period from 1st to 72nd hours.;To compare the total amount of rescue analgesic consumption in the postoperative period.Timepoint: postoperative period from 1st to 72nd hours—

Countries

India

Contacts

Public ContactDr Sneka Priyadharsini V

Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research

drpathin2@gmail.com9787740890

Outcome results

None listed

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