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Comparative study of two different drugs when used with a standard drug ,in patients undergoing spinal anaesthesia to find out which has better patient tolerence and pain releif in orthopaedic surgeries

A comparative study of intrathecal hyperbaric ropivacaine with fentanyl versus hyperbaric bupivacaine with fentanyl for orthopedic surgeries

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/052583
Enrollment
200
Registered
2023-05-12
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: spinal anaesthesia with inj bupivacaine with fentanyl: Written informed consent to perform subarachnoid block will be taken from all the patients. i) Grouping and Randomization: 200 pat
(III): Intraoperative and postoperative period till 60mins post operatively. viii) SAB were performed as per routine care and safety with 25 gauge Quincke spinal needle via midline approach in each pa

Sponsors

College of Medicine and JNM hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a)Patient who gives written consent. b)ASA-Ð? &Ð?Ð? c)Age â?? 18-55 years of both sexes d)Any patient posted for elective lower extrimity orthopedic surgery to be done under subarachnoid block

Exclusion criteria

Exclusion criteria: a) Patient who does not give or not in a mental state to consent due to any reason. b)Any contraindication to SAB c)Patient requiring intraoperative any general anaesthetic aid

Design outcomes

Primary

MeasureTime frame
Comparison of analgesic duration following, hyperbaric Ropivacaine-Fentanyl vs Bupivacaine- fentanyl :duration of sensory, motor block, spinal anaesthesia, time of rescue analgesiaTimepoint: Comparison of analgesic duration following, hyperbaric Ropivacaine-Fentanyl vs Bupivacaine- fentanyl at 15, 30,45,60

Secondary

MeasureTime frame
Comparison of postoperative pain relief following, Ropivacaine-Fentanyl vs Bupivacaine-fentanylTimepoint: Continuous ECG in lead II, SBP, DBP, MAP, HR, RR, SpO2 will be recorded 15 minutes before and at the time of spinal anaesthesia, then at 1 minute, at 3 minute, at 5 minute, thereafter at 5 minutes interval throughoutthe entire surgical procedure and at 15 minutes interval during first 60 minutes of post-operative period.

Countries

India

Contacts

Public ContactDr Uma Mandal

College of Medicine and JNM Hospital, Kalyani

uma.mandal01@gmail.com8777695486

Outcome results

None listed

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