FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/070390 [Registered on: 10/07/2024] Trial Registered Prospectively
Last Modified On: 19/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of 0.5% Levo-bupivacaine and 0.5% Ropivacaine in combined sciatic and femoral nerve block using ultrasound guidance in below knee orthopaedic surgery. 
Scientific Title of Study   Comparative study of 0.5% Levo-bupivacaine versus 0.5% Ropivacaine in combined sciatic and femoral nerve block in below knee orthopedic surgery under ultrasound guidance. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Prity Rani Tirkey  
Designation  Academic Junior Resident  
Affiliation  Rajendra institute of medical science, Ranchi  
Address  Department of Anesthesiology, RIMS hospital campus, Bariatu, Ranchi

Ranchi
JHARKHAND
834009
India 
Phone  9955305612  
Fax    
Email  mariaprity26@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Saurabh Suman  
Designation  Assistant professor  
Affiliation  Rajendra institute of medical science, Ranchi  
Address  Department of Anesthesiology, Rajendra institute of medical science, Ranchi

Ranchi
JHARKHAND
834009
India 
Phone  7079893536  
Fax    
Email  Saurabh31.7.dmch@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Saurabh Suman  
Designation  Assistant professor  
Affiliation  Rajendra institute of medical science, Ranchi  
Address  Department of Anesthesiology, Rajendra institute of medical science, Ranchi

Ranchi
JHARKHAND
834009
India 
Phone  7079893536  
Fax    
Email  Saurabh31.7.dmch@gmail.com  
 
Source of Monetary or Material Support  
Rajendra institute of medical science, Ranchi, Jharkhand,pin-834009 , India  
 
Primary Sponsor  
Name  Rajendra institute of medical science  
Address  Bariatu, Ranchi , Jharkhand,pin- 834009, India  
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 Prity Rani Tirkey   Rajendra institute of medical science, Ranchi   Department of orthopaedic (Orthopaedic OT) and department of Anesthesiology
Ranchi
JHARKHAND 		 9955305612

mariaprity26@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee , Rajendra institute of medical science, Ranchi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S829||Unspecified fracture of lower leg,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  0.5% Levo-bupivacaine   Under ultrasound guidance single dose of 12ml of 0.5% Levo-bupivacaine will be injected near sciatic nerve and single dose of 8ml of 0.5% Levo-bupivacaine will be injected near femoral nerve and patient will be observed till 12 hour after surgery.  
Comparator Agent  0.5% Ropivacaine   Under ultrasound guidance single dose of 12ml of 0.5% Ropivacaine will be injected near sciatic nerve and single dose of 8ml of 0.5% Ropivacaine will be injected near femoral nerve and patient will be observed till 12 hour after surgery  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA grade 1 and 2, no known neurological deficit, surgery - orthopaedic surgery below knee  
 
ExclusionCriteria 
Details  ASA grade 3 and 4, patient with neurological disorders, history of allergy to study drug  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of 0.5% Levo-bupivacaine versus 0.5% Ropivacaine in combined sciatic and femoral nerve block under ultrasound guidance in patients undergoing below knee orthopaedic surgery   After induction
End of surgery
12 hour postoperative  
 
Secondary Outcome  
Outcome  TimePoints 
To study hemodynamic changes of 0.5% Levo-bupivacaine and 0.5% Ropivacaine   After induction
End of surgery  
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
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)   20/07/2024 
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="5"
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   Regional anaesthesia are increasingly the preferred and best option for wide range of lower limb surgeries.It is said to provide surgical anaesthesia with better cardio- respiratory stability and to cause least interferance with the vital physiological function of the body.
Levo-bupivacaine has strongly emerged as a safer alternative for regional anaesthesia and is less cardiotoxic. Ropivacaine is documented to have comparable levels and duration of analgesia, lesser cardiotoxicity for the same duration of analgesia in comparison to Bupivacaine.
The purpose of the present study is to evaluate the efficacy of 0.5% Levo-bupivacaine and 0.5% Ropivacaine in combined sciatic and femoral nerve block for below knee orthopaedic surgery, by studying the onset and duration of sensory and motor blockade and the hemodynamic changes.
 
Close