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CTRI Number  CTRI/2024/11/076139 [Registered on: 01/11/2024] Trial Registered Prospectively
Last Modified On: 09/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   COMPARISON OF LEVOBUPIVACAINE AND LEVOBUPIVACAINE WITH FENTANYL IN POPLITEAL BLOCK USING ULTRASOUND FOR BELOW-KNEE SURGERIES 
Scientific Title of Study   COMPARISON OF LEVOBUPIVACAINE AND LEVOBUPIVACAINE WITH FENTANYL IN POPLITEAL BLOCK USING ULTRASOUND FOR BELOW-KNEE SURGERIES-RANDOMISED CLINICAL TRAIL. 
Trial Acronym  RANDOMIZED CLINICAL TRIAL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DRKOPPU NAGA SAI SNEHITHA 
Designation  JUNIOR RESIDENT (PG) 
Affiliation  BLDE (DEEMED TO BE UNIVERSITY). 
Address  ANAESTHESIOLOGY DEPT SHRI BM PATIL MEDICAL COLLEGEHOSPITAL AND RESEARCH CENTRE,BANGARAMMA SAJJAN CAMPUS,SOLAPUR ROAD,VIJAYAPURA

Bijapur
KARNATAKA
586103
India 
Phone  9989117641  
Fax    
Email  snehithakoppu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DRPRATIBHA S D  
Designation  ASSOCIATE PROFESSOR 
Affiliation  BLDE (DEEMED TO BE UNIVERSITY). 
Address  OT COMPLEX 3RD FLOOR,DEPT OF ANAESTHESIA SHRI BM PATIL MEDICAL COLLEGEHOSPITAL AND RESEARCH CENTRE,BANGARAMMA SAJJAN CAMPUS,SOLAPUR ROAD,VIJAYAPURA
OT COMPLEX 3RD FLOOR,DEPT OF ANAESTHESIA SHRI BM PATIL MEDICAL COLLEGEHOSPITAL AND RESEARCH CENTRE,BANGARAMMA SAJJAN CAMPUS,SOLAPUR ROAD,VIJAYAPURA
Bijapur
KARNATAKA
586103
India 
Phone  9036110082  
Fax    
Email  pratibhakaradi@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR PRATIBHA S D  
Designation  ASSOCIATE PROFESSOR 
Affiliation   
Address  DEPT OF ANAESTHESIA SHRI BM PATIL MEDICAL COLLEGEHOSPITAL AND RESEARCH CENTRE,BANGARAMMA SAJJAN CAMPUS,SOLAPUR ROAD,VIJAYAPURA

Bijapur
KARNATAKA
586103
India 
Phone  9036110082  
Fax    
Email  pratibhakaradi@gmail.com  
 
Source of Monetary or Material Support  
SHRI B.M PATIL MEDICAL COLLEGE ,DEPT OF ANAESTHESIA SHRI BM PATIL MEDICAL COLLEGEHOSPITAL AND RESEARCH CENTRE,BANGARAMMA SAJJAN CAMPUS,SOLAPUR ROAD,VIJAYAPURA,586101  
 
Primary Sponsor  
Name  dr snehitha 
Address  OT COMPLEX 3RD FLOOR DEPT OF ANAESTHESIA SHRI BM PATIL MEDICAL COLLEGEHOSPITAL AND RESEARCH CENTRE,BANGARAMMA SAJJAN CAMPUS,SOLAPUR ROAD,VIJAYAPURA-586103 
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 
DRKOPPU NAGA SAI SNEHITHA  SHRI BM PATIL MEDICAL COLLEGE HOSPITAL  OT COMPLEX 3RD FLOOR,DEPT OF ANAESTHESIA SHRI BM PATIL MEDICAL COLLEGEHOSPITAL AND RESEARCH CENTRE,BANGARAMMA SAJJAN CAMPUS,SOLAPUR ROAD,VIJAYAPURA,586101.
Bijapur
KARNATAKA 		 9989117641

snehithakoppu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  LEVOBUPIVACAINE   randamised trail. 20ML OF 0.5%LEVOBUPIVACAINE+ 0.9% NS 1ML IS INJECTED IN GROUP A PATIENTS THROUGH ULTRASOUND GUIDED POPLITEAL BLOCK Edit || Delete  
Comparator Agent  LEVOBUPIVACAINE WITH FENTANYL   20ML OF 0.5%LEVOBUPIVACAINE+ 0.9% NS 1ML IS INJECTED IN GROUP A PATIENTS THROUGH ULTRASOUND GUIDED POPLITEAL BLOCK 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  The study will be done in patients of ASA grades I and II posted for below knee surgeries 
 
ExclusionCriteria 
Details  1)ASA grade III and IV
2)Local infection at the site of injection
3)History of allergy to local anaesthetic drug
4)Pregnant women 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1)To compare the onset of sensory analgesia and duration of motor blockade
intraoperatively
2)To compare the duration of postoperative sensory analgesia in both the groups 		 Till first rescue analgesic request 
 
Secondary Outcome  
Outcome  TimePoints 
1)To compare intraoperative and postoperative hemodynamic variables such as heart rate,non-invasive blood pressure and oxygen saturation
2)To observe adverse effects like Hypotension,Bradycardia,nausea,vomiting,nerve injury,LAST(Local Anesthetic Systemic Toxicity),hematoma 		 Till first rescue analgesic request 
 
Target Sample Size   Total Sample Size="114"
Sample Size from India="114" 
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)   15/11/2024 
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="3"
Months="0"
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
Modification(s)  
AIM

To compare the efficacy of 0.5%Levobupivacaine and 0.5%Levobupivacaine with fentanyl intraoperatively and postoperatively in the ultrasound guided popliteal block for below-knee surgeries

NEED FOR THE STUDY

  1. Regional anesthesia is better alternative to general anesthesia in limb surgeries for patients with comorbidities as general anaesthesia changes patients hemodynamic status
  2. Peripheral nerve blocks reduce the requirement of intravenous analgesia and provide intraoperative as well as postoperative analgesia
  3. Popliteal block for below-knee surgeries provides hemodynamic stability, profound analgesic effect, avoids systemic complications,and allows early discharge from PACU
  4. Ultrasound guidance shortens block onset time,allows dose reduction of local anaesthetic drug,reduces the number of needle passes and increases success rate with improved block quality
  5. Levobupivacaine is safer,has less cardiovascular and neurological toxicity and provides comparable motor blockade as Bupivacaine
  6. therefore,study will be done to assess the effect of narcotic drug,Fentanyl in popliteal blockade                                                                                                                                                                                                                                                                                                                                                                                           HYPOTHESIS                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         0.5%Levobupivacaine with fentanyl is more efficacious than sole 0.5%Levobupivacaine in popliteal block for below-knee surgeries.

 
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