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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.

Not Applicable
Conditions
Health Condition 1: N00-N99- Diseases of the genitourinary systemHealth Condition 2: N80-N98- Noninflammatory disorders of female genital tract
Registration Number
CTRI/2022/06/043482
Lead Sponsor
Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Women (Age-18 â?? 60 ).

ASA classes I to III.

Those posted for transabdominal gynecological surgeries performed with pfannenstiel incision.

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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. <br/ ><br>Visual analog scale (VAS) at movement is recorded at postoperative period of 24th,28th,32nd,36th,40th,44th,48th,72nd hours. <br/ ><br>
Secondary Outcome Measures
NameTimeMethod
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
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