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CTRI Number  CTRI/2025/04/083840 [Registered on: 02/04/2025] Trial Registered Prospectively
Last Modified On: 01/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Studying the effectiveness of ultrasound-guided caudal block for pain relief after femur fracture surgery with spinal anesthesia. 
Scientific Title of Study   To Study the efficacy of ultrasound guided caudal block for post operative analgesia in patients undergoing femur fracture surgery under subarachnoid block 
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 Lalita Choudhary 
Designation  Junior resident  
Affiliation  Mahatma Gandhi medical college and hospital, Jaipur  
Address  2nd floor OT complex, Department of anesthesia at Mahatma Gandhi medical college and hospital, Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  9414038471  
Fax    
Email  Lalita16y@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mangilal deganwa 
Designation  Associate Professor 
Affiliation  Mahatma Gandhi medical college and hospital 
Address  2nd floor OT complex, OT No. 8 orthopedic OT, Department of anesthesia at Mahatma Gandhi medical college and hospital, Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  9871495240  
Fax    
Email  mangilaldeganwa0606@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mangilal deganwa 
Designation  Associate Professor 
Affiliation  Mahatma Gandhi medical college and hospital 
Address  2nd floor OT complex, OT No. 8 orthopedic OT, Department of anesthesia at Mahatma Gandhi medical college and hospital, Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  9871495240  
Fax    
Email  mangilaldeganwa0606@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Medical College And Hospital, Sitapura, Jaipur, Rajasthan 302022 India  
 
Primary Sponsor  
Name  Mahatma Gandhi medical college and hospital 
Address  Department of anaesthesiology and critical care, Mahatma Gandhi medical college and hospital, Sitapura ,Jaipur, Jaipur 302022 India  
Type of Sponsor  Private 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 Lalita Choudhary  Mahatma Gandhi Medical College and Hospital  Department of anesthesiology, Critical care and pain management, OT complex, Second floor, Main hospital building, Jaipur, Rajasthan.
Jaipur
RAJASTHAN 		 9414038471

lalita16y@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, Mahatma Gandhi medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S729||Unspecified fracture of femur, (2) ICD-10 Condition: S729||Unspecified fracture of femur, (3) ICD-10 Condition: S729||Unspecified fracture of femur, (4) ICD-10 Condition: S729||Unspecified fracture of femur,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Caudal block  Ultrasound guided caudal block with 0.2% Ropivacaine 0.3-0.5 ml/kg in caudal epidural space  
Comparator Agent  Intravenous analgesia.   Alternative intravenous pain management group who receive intravenous tramadol 2mg/kg. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patient scheduled for femur fracture surgeries under subarachnoid block.
Patient with ASA grade I,II and III. 
 
ExclusionCriteria 
Details  Subject’s refusal to participate in the study
Any bleeding disorder or patient on anticoagulants.
Neurological deficits
History of drug allergy.
Local infection at the injection site.
Patients on any sedatives or antipsychotics. 
 
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 
Assessment of pain using VAS ( visual analogue scale ) score at interval of 2hrs for 24hrs between the two groups.
Group A : Ultrasound Guided caudal block group- 0.2% Ropivacaine 0.3-0.5ml/kg
Group B : The alternative intravenous pain management group (Control group)
 		 0,2nd hour, 4th hour, 6th hour, 8th hour, 10th hour, 12th hour, 14th hour, 16th hour, 18th hour, 20th hour, 22nd hour, 24th hour. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the time of first rescue analgesia between the two groups.
To assess & compare the total dose required in first 24 hour post- operatively in both patient groups.
 		 0,2nd hour, 4th hour, 6th hour, 8th hour, 10th hour, 12th hour, 14th hour, 16th hour, 18th hour, 20th hour, 22nd hour, 24th hour. 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   01/05/2025 
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)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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  
It is a prospective, randomised, hospital based study to be conducted by Department of Anaesthesia, Mahatma Gandhi Medical College & Hospital, Jaipur.
After ethical committee’s approval, informed written consent will be obtained from all patients.
After doing all the required investigation, PAC will be performed a day before the surgery.
Patients will be randomly divided into two groups of 35 each with the help of computer generated randomization tables method. All patients will be explained about the technique.
 
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