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CTRI Number  CTRI/2023/12/060779 [Registered on: 26/12/2023] Trial Registered Prospectively
Last Modified On: 19/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Study on comparing the effectiveness of pericapsular nerve group block between ropivacaine and ropivacaine with dexmedetomidine in patients with hip fractures. 
Scientific Title of Study   EVALUATION OF EFFECTIVENESS OF PERICAPSULAR NERVE GROUP(PENG) BLOCK WITH ROPIVACAINE VS ROPIVACAINE WITH DEXMEDETOMIDINE IN PATIENTS WITH HIP FRACTURES - A RANDOMIZED CONTROLLED STUDY  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  K Jeyanthi  
Designation  First year post graduate  
Affiliation  SRI VENKATESHWARAA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE  
Address  Room no.315 , Department of Anaesthesia OT complex,Sri Venkateshwaraa medical college, hospital and research centre ,No.13A, pondicherry villupuram main road, Ariyur Pondicherry
Room no.315 , Department of Anaesthesia OT complex,Sri Venkateshwaraa medical college, hospital and research centre ,No.13A, pondicherry villupuram main road, Ariyur Pondicherry
Pondicherry
PONDICHERRY
605102
India 
Phone  9600817648  
Fax    
Email  jeyanthik97@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR.P.NAGALAKSHMI  
Designation  professor 
Affiliation  SRI VENKATESHWARAA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE  
Address  Room no.315, Department of Anaesthesia OT complex,Sri Venkateshwaraa medical college, hospital and research centre, No.13A,pondicherry villupuram main road Ariyur Pondicherry
Room no.315, Department of Anaesthesia OT complex,Sri Venkateshwaraa medical college, hospital and research centre, No.13A,pondicherry villupuram main road Ariyur Pondicherry
Pondicherry
PONDICHERRY
605102
India 
Phone  9894510137  
Fax    
Email  vedha83@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR.P.NAGALAKSHMI  
Designation  professor 
Affiliation  SRI VENKATESHWARAA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE  
Address  Room no.315, Department of Anaesthesia OT complex,Sri Venkateshwaraa medical college, hospital and research centre, No.13A,pondicherry villupuram main road Ariyur Pondicherry
Room no.315, Department of Anaesthesia OT complex,Sri Venkateshwaraa medical college, hospital and research centre, No.13A,pondicherry villupuram main road Ariyur Pondicherry
Pondicherry
PONDICHERRY
605102
India 
Phone  9894510137  
Fax    
Email  vedha83@gmail.com  
 
Source of Monetary or Material Support  
Sri Venkateshwaraa medical college hospital and research centre  
 
Primary Sponsor  
Name  Dr k. Jeyanthi  
Address  Sri Venkateshwaraa medical college hospital and research centre Ariyur, pondicherry,605102 
Type of Sponsor  Other [Self funding ] 
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Jeyanthi   Sri Venkateshwaraa medical college, hospital and research centre  Department of Anaesthesia,OT complex,Ortho division,room no.8,pondicherry villupuram road, Ariyur,pondicherry
Pondicherry
PONDICHERRY 		 9600817648

jeyanthik97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Injection ropivacaine 0.25% 20 ml in PENG block  To find out the analgesic effectiveness and onset of pain relief during patient positioning and post operative analgesia of 0.25% ropivacaine 20 ml in PENG block. 
Intervention  Injection ropivacaine 0.25% 20ml with injection dexmedetomidine 25 mcg  To find out the analgesic effectiveness and onset of pain relief during patient positioning and post operative analgesia of 0.25% ropivacaine 20 ml and dexmedetomidine 25 mcg in PENG block. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients belonging to ASA grade 1,2 and 3 with hip fractures, posted for surgery under spinal anaesthesia who are unable to sit due to pain in the hip joint.

Patients of either sex above 18 years of age. 
 
ExclusionCriteria 
Details  Patients with hemorrhagic diasthesis, neurocognitive disorders,spinal deformities, psychiatric disorders.
Patients with allergy to study drug.
Patients with polytrauma, infection over injected site. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the onset of pain relief & reduction in pain score(VAS)during the positioning of patients for central neuraxial blockade with 0.25% ropivacaine 20ml and 0.25% ropivacaine 20ml and dexmedetomidine 25 mcg  duration of onset of pain relief will be noted at 5,10,15,20,30 minutes after the block 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the duration of post operative pain relief in both groups & to assess the total analgesic requirements for 24 hours   18 months  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   29/12/2023 
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 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   The study is a double blinded randomised control study to compare the analgesic effectiveness of Pericapsular nerve group (PENG) block with ropivacaine vs ropivacaine with dexmedetomidine in patients with hip fractures.The study will be conducted on patients above 18 years of age and belonging to ASA 1,2,3 with hip fractures 
The study will be conducted for a period of 18 months in patients with hip fractures coming to Sri Venkateshwaraa medical college ,hospital and research centre .The primary objective is to compare the onset of pain relief and reduction in pain score(VAS) during the positioning of patients for central neuraxial blockade between the two groups.
The secondary objective is to access  the duration of post operative pain relief in both groups and to access the total analgesic requirements for 24 hours.
 
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