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 yet recruiting

• Conditions: Diseases of the genitourinary system, (2) ICD-10 Condition: 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

This study is a prospective randomized study comparing evaluation of transdermal buprenorphine and transdermal fentanyl for postoperative pain relief after gynaecological surgeries that will be conducted in Melmaruvathur adhiparasakthi institute of medical sciences and research. Primary outcome will be postoperative analgesic efficacy between the groups. Secondary outcome will be time to rescue analgesia between the groups, total amount of rescue analgesic consumption, hemodynamic parameters( heart rate, respiratory rate,systolic blood pressure, diastolic blood pressure, mean arterial pressure, oxygen saturation) and anticipated side effects between groups in post operative period from first to seventy second hour.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-06-15
• Study Start: 2022-06-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 74

Inclusion Criteria

• Women (Age-18 – 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

Name	Time	Method
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.	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 Outcome Measures

Name	Time	Method
To compare the total amount of rescue analgesic consumption in the postoperative period.	postoperative period from 1st to 72nd hours
To compare the time to rescue analgesia between the groups.	Postoperative period from 1st to 72nd hours.
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.	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.	postoperative period from 1st to 72nd hours.

Trial Locations

Locations (1)

Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research; 🇮🇳 Kancheepuram, TAMIL NADU, India

Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research

🇮🇳Kancheepuram, TAMIL NADU, India

DrSneka Priyadharsini V

Principal investigator

9488319024

snekamohan95@gmail.com