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CTRI Number  CTRI/2025/07/091336 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 21/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study to find the most comfortable sitting position for spinal anaesthesia in participants with knee fractures  
Scientific Title of Study   Comparison of hamstring stretch position and modified rider sitting position in patients with fracture around the knee undergoing spinal anaesthesia  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prathvi Shetty 
Designation  Post graduate student  
Affiliation  Manipal College of Health Professions 
Address  Anaesthesia and Operation Theatre Technology program 5th floor Manipal College of Health Professions Manipal Academy of Higher Education Manipal Udupi Karnataka India

Udupi
KARNATAKA
576104
India 
Phone  8431488683  
Fax    
Email  prathvi1.mchpmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Ramyatha Aithal  
Designation  Assistant Professor and guide  
Affiliation  Kasturba Medical College and Hospital, Manipal 
Address  Department of Anaesthesiology, Kasturba Hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9481018932  
Fax    
Email  ramyatha.aithal@manipal.edu   
 
Details of Contact Person
Public Query  
Name  Prathvi Shetty 
Designation  Post graduate student  
Affiliation  Manipal College of Health Professions 
Address  Anaesthesia and Operation Theatre Technology program 5th floor Manipal College of Health Professions Manipal Academy of Higher Education Manipal Udupi Karnataka India

Udupi
KARNATAKA
576104
India 
Phone  8431488683  
Fax    
Email  prathvi1.mchpmpl2024@learner.manipal.edu  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Prathvi Shetty 
Address  Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka  
Type of Sponsor  Other [Self ] 
 
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 
Prathvi Shetty  Kasturba Hospital   Kasturba Hospital and Medical College Manipal Udupi Karnataka India
Udupi
KARNATAKA 		 8431488683

prathvi1.mchpmpl2024@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 (Student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  ASA I, II, III
Patients diagnosed with fractures around the knee planned under spinal anaesthesia
Patients capable of adapting both Hamstring stretch position (HSP) and modified rider setting
position (mRSP) prior to acute injury as per history 
 
ExclusionCriteria 
Details  Patients with any spine deformities
Previous spine surgery
Patients with lower back pain
Patients with pelvic trauma
Pregnancy
Patients with neurocognitive disability
Injury to both lower limbs
Patients with contraindication to spinal anaesthesia-hypovolemia, coagulopathy, raised
intracranial pressure or head injury, fixed cardiac output state
Patients with obese body habitus
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare patient’s comfort between hamstring stretch position and modified rider sitting position during spinal anaesthesia  Pre-operative area  
 
Secondary Outcome  
Outcome  TimePoints 
To compare anaesthetist’s ease in finding interspinous space in both Hamstring stretch position and modified rider sitting position  Pre-operative area 
 
Target Sample Size   Total Sample Size="94"
Sample Size from India="94" 
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   N/A 
Date of First Enrollment (India)   08/08/2025 
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="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 important as it seeks to identify the optimal position for patients with knee fractures undergoing spinal anesthesia, which can improve both comfort and the efficacy of the anesthesia. By comparing the hamstring stretch position and modified rider sitting position, the research aims to determine which positioning method reduces pain and enhances the success of spinal anesthesia. The findings could help minimize complications and improve postoperative recovery by identifying a position that promotes better mobility and fewer discomforts after the procedure. This study could contribute to evidence-based clinical practices, providing valuable data for refining anesthesia techniques in knee fracture surgeries. Ultimately, it holds the potential to improve patient care, enhance recovery outcomes, and reduce healthcare costs. 
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