It is the study done in lower limb orthopedic surgeries to assess postoperative pain. The study is done to know the efficacy of epidural fentanyl and buprenorphine as an adjuvant to ropivacaine.

Phase 3

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/06/053993
• Lead Sponsor: Dr Sontakke Mahananda Ramrao

Brief Summary

1.It is a comparative study between epidural ropivacaine with fentanyl and ropivacaine with buprenorphine for post operavtive analgeia in lower limb orthopedic surgeries

2.It is between two groups-Group A and Group B



OBJECTIVES-



1.    To studythe efficacy of epidural fentanyl and buprenorphine as an adjuvant  to ropivacaine for post operative analgesia.

2.    To comparethe duration of post operative analgesia forropivacaine with fentanyl and ropivacaine with buprenorphine.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-06-16
• Study Start: 2023-07-17

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1 All patients posted for lower limb orthopedic surgery.
• 2 Patients who belongs toAmerican Society of Anaesthesiology grade I andII.
• 3 Age group 18-80 years.

Exclusion Criteria

• 1.Patients on opioid or sedative medication in the week prior to the surgery.
• 2.Patients with history of alcohol or drug abuse.
• 3.History of coagulation disorders or on anti coagulant drug.
• 4.Patients who have known allergies to any of test drugs.
• 5.Known case of respiratory diseases.
• 6.Contraindications for epidural anaesthesia.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To study the efficacy of epidural fentanyl and buprenorphine as an adjuvant to ropivacaine for post operative analgesia.	1.To study the efficacy of epidural fentanyl and buprenorphine as an adjuvant to ropivacaine for post operative analgesia at baseline.
2.To compare the duration of post operative analgesia for ropivacaine with fentanyl and ropivacaine with buprenorphine.	1.To study the efficacy of epidural fentanyl and buprenorphine as an adjuvant to ropivacaine for post operative analgesia at baseline.

Secondary Outcome Measures

Name	Time	Method
To study systemic side effects of fentanyl and buprenorphine	1.To compare the duration of post operative analgesia for ropivacaine with fentanyl and ropivacaine with buprenorphine for 24 hours.

Trial Locations

Locations (1)

Basaweshwar teaching and general hospital; 🇮🇳 Gulbarga, KARNATAKA, India

Basaweshwar teaching and general hospital

🇮🇳Gulbarga, KARNATAKA, India

Harshita Muralidhar

Principal investigator

9482861478

mharshita16@gmail.com