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CTRI Number  CTRI/2025/07/091084 [Registered on: 17/07/2025] Trial Registered Prospectively
Last Modified On: 16/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of efficacy of two drugs in combination for spinal anaesthesia in aged patients undergoing hip surgery  
Scientific Title of Study   Comparative Efficacy of Hyperbaric Bupivacaine With Fentanyl and Hyperbaric Ropivacaine With Fentanyl in Terms of Haemodynamic Stability and Block Characteristics in Elderly Patients Undergoing Elective Hip Hemiarthroplasty: A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Chaitanya Shetty 
Designation  Post graduate 
Affiliation  Ballari Medical College and Research Centre, Ballari 
Address  Department of Anaesthesiology Ballari Medical College and Research Centre Vijayanagar Cantonment Ballari

Bellary
KARNATAKA
583104
India 
Phone  7975895951  
Fax    
Email  chaitanyashetty692@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bala Subramanya H 
Designation  Professor 
Affiliation  Ballari Medical College and Research Centre 
Address  56, Swasthi Hilltown layout Bhatri Road Vidyanagar Ballari
Department of Anaesthesiology Ballari Medical College and Research Centre Vijayanagar Cantonment Ballari 583104
Bellary
KARNATAKA
583104
India 
Phone  9980600724  
Fax    
Email  halsanadu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bala Subramanya H 
Designation  Professor 
Affiliation  Ballari Medical College and Research Centre 
Address  56, Swasthi Hilltown layout Bhatri Road Vidyanagar Ballari
Department of Anaesthesiology Ballari Medical College and Research Centre Vijayanagar Cantonment Ballari 583104
Bellary
KARNATAKA
583104
India 
Phone  9980600724  
Fax    
Email  halsanadu@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Ballari Medical College and Research Centre 
Address  Cantonment Ballari Karnataka State Pin 583104 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chaitanya Shetty  Ballari Medical College and Research Centre   Department of Anaesthesiology Ballari Medical College and Research Centre Vijayanagar Cantonment Ballari Karnataka 583104
Bellary
KARNATAKA 		 7975895951

chaitanyashetty692@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, Ballari Medical College and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S720||Fracture of head and neck of femur,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intrathecal 0.5 % hyperbaric bupivacaine 10mg with 25mcg of fentanyl  10mg of 0.75% hyperbaric ropivacaine with 25mcg of fentanyl is administered intrathecally for spinal anesthesia for duration of 4 to 4.5 hours 
Intervention  Intrathecal 0.75 % hyperbaric ropivacaine 15mg with 25mcg of fentanyl   15mg of 0.75% hyperbaric ropivacaine with 25mcg of fentanyl is administered intrathecally for spinal anaesthesia for duration of 3.5 to 4 hours 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1)Patients undergoing elective hip hemiarthroplasty
2)Patients belonging to ASA II - III
 
 
ExclusionCriteria 
Details  1)Patients refusal for spinal anaesthesia
2)History of allergy to study drugs
3)Any contra indication for spinal anaesthesia
4)Any severe systemic disorder
5)Patients with impaired hearing and known cognitive impairment
6)Morbid Obesity
7)Patients with poly trauma

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare total dose of phenylephrine required intra operatively to maintain haemodynamic stability in two groups  4 hours , 5 hours  
 
Secondary Outcome  
Outcome  TimePoints 
Intra operative haemodynamic changes
 		 1 min, 2min, 3min, 4min, 6min, 8min,10min,20min,30min, 40min,60min,90min 
Onset & duration of motor blockade  1 min, 2min, 3min, 4min, 6min, 8min,10min,20min,30min, 40min,60min,90min 
Pain using NRS  1 min, 2min, 3min, 4min, 6min, 8min,10min,20min,30min, 40min,60min,90min 
Incidence & severity of PONV  5min, 15min,30 min, 45min,60min,90min,120min, 150min,180min,210min,240min,270min,300min post operatively 
Adverse reactions related to fentanyl  5min, 15min,30 min, 45min,60min,90min,120min, 150min,180min,210min,240min,270min,300min post operatively 
Other adverse intra operative events including ECG changes  1 min, 2min, 3min, 4min, 6min, 8min,10min,20min,30min, 40min,60min,90min 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This study is a randomized,  parallel-group, single-centre trial comparing the efficacy of intrathecal 0.5% hyperbaric bupivacaine with fentanyl and 0.75% hyperbaric ropivacaine with fentanyl in 92 elderly patients (aged 60–80 years) undergoing elective hip hemiarthroplasty. The study will be conducted at Ballari Medical College and Research Centre, India.

The primary outcome is the total intraoperative requirement of phenylephrine (in micrograms) to maintain haemodynamic stability.

Secondary outcomes include intraoperative hemodynamic parameters, onset and duration of sensory and motor block, two-segment regression time, pain scores (NRS), postoperative nausea and vomiting (PONV), and fentanyl-related side effects such as pruritus, respiratory depression, and urinary retention.
 
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