A Clinical study to compare effect of two drugs hyperbaric ropivacaine with fentanyl in Intrathecal blockade in lower limb orthopedic surgeries.

Recruiting

• Conditions: Measurement and Monitoring, (2) ICD-10 Condition: 4||Measurement and Monitoring,

• Registration Number: CTRI/2023/08/056732
• Lead Sponsor: ARPITHA S

Brief Summary

**PURPPOSE -**

Comparative study of Intrathecal hyperbaric ropivacaine versus hyperbaric ropivacaine with fentanyl  as adjuvant in lower limb orthopedic surgeries**.**

**JUSTIFICATION / NEED FOR STUDY**

Studies show that hyperbaric ropivacaine has safer cardiac profile compared to bupivacaine. Addition of Fentanyl will prolong the onset of blockage thus making it more hemodynamically stable.Hence we wanted to  do comparative study of intrathecal  hyperbaric ropivacaine versus hyperbaric ropivacaine with fentanyl as adjuvant in lower limb orthopedic surgeries on block characteristics, hemodynamic parameters,side effect profile and postoperative analgesia.

AIM: is to study the efficacy of intrathecal  fentanyl as an adjuvant to hyperbaric ropivacaine for lower limb orthopedic surgeries.

OBJECTIVES - To compare onset and duration  of sensory and motor block , post operative  analgesic effect, hemodynamic changes of intrathecal hyperbaric Ropivacaine and hyperbaric Ropivacaine with fentanyl as adjuvant.

**To evaluate and compare the adverse effects .**

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-09
• Last Update Posted: 2024-01-25

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

Adults aged between 18-60years patients who are scheduled for lower limb orthopedic surgery under spinal anesthesia Gender: Both Male and Female ASA PS: I,2.

Exclusion Criteria

Adult patients aged between 18-60 years who are undergoing emergency lower limb orthopedic surgeries Cardiovascular disease Prolonged surgeries (>3hours) or if it is converted to general anaesthesia Patients with coagulopathy Known contraindication for spinal anesthesia.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neuraxial blockade	24hours

Secondary Outcome Measures

Name	Time	Method
1) sensory blockade	2) request for first analgesia

Trial Locations

Locations (1)

Yenepoya medical college; 🇮🇳 Kannada, KARNATAKA, India

Yenepoya medical college

🇮🇳Kannada, KARNATAKA, India

Dr Shankaranarayana

Principal investigator

9449568734

drbhatta77@yahoo.co.in