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CTRI Number  CTRI/2024/04/065824 [Registered on: 16/04/2024] Trial Registered Prospectively
Last Modified On: 12/04/2024
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   Comparing 4-1 block against epidural for pain relief in knee and below knee surgeries 
Scientific Title of Study   Novel vs Traditional : Comparison of 4-l block vs epidural for post operative analgesic needs in knee and below knee surgeries 
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 Suprava Kundu 
Designation  DNB (3 year course} post graduate Resident  
Affiliation  NH MMI Superspecialty Hospital  
Address  2nd floor, OT complex , Department of Anaesthesiology , MMI Narayana superspecialty Hospital ,Dhamtari Road, Lalpur, Raipur, Chhattisgarh

Raipur
CHHATTISGARH
492001
India 
Phone  7978661948  
Fax    
Email  kundu.suprava@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arun Andappan 
Designation  Senior Consultant  
Affiliation  NH MMI Superspecialty Hospital 
Address  2nd floor, OT complex , Department of Anaesthesiology , MMI Narayana superspecialty Hospital ,Dhamtari Road, Lalpur, Raipur, Chhattisgarh

Raipur
CHHATTISGARH
492001
India 
Phone  9584411011  
Fax    
Email  arunandappan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arun Andappan 
Designation  Senior Consultant  
Affiliation  NH MMI Superspecialty Hospital 
Address  2nd floor, OT complex , Department of Anaesthesiology , MMI Narayana superspecialty Hospital ,Dhamtari Road, Lalpur, Raipur, Chhattisgarh


CHHATTISGARH
492001
India 
Phone  9584411011  
Fax    
Email  arunandappan@gmail.com  
 
Source of Monetary or Material Support  
MMI Narayana Superspecialty Hospital, Raipur ,Chhattisgarh, pincode- 492001, India  
 
Primary Sponsor  
Name  MMI Narayana superspecialty Hospital 
Address  new Dhamtari road, Pachpedi naka ,Lalpur, Raipur, Chhattisgarh 
Type of Sponsor  Research institution and hospital 
 
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 Suprava Kundu  MMI Narayana Superspecialty Hospital  2nd floor, OT complex , Department of Anaesthesiology , MMI Narayana superspecialty Hospital ,Dhamtari Road, Lalpur, Raipur, Chhattisgarh
Raipur
CHHATTISGARH 
7978661948

kundu.suprava@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee,All India Institute of Medical Sciences, Raipur(Chhattisgarh)   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 
Comparator Agent  Continuous epidural block  bolus of 0.25% Bupivacaine 5 ml with 0.5 mcg/kg Dexmedetomidine followed followed by infusion of 0.25% Bupivacaine 50 ml with 0.5 mcg/kg Dexmedetomidine at 5ml/hr 
Intervention  Four in one block (4-1 block)  USG Guided 4-1 block given with 0.2% ropivacaine 35 ml along with 0.5 mcg/kg Dexmedetomidine in knee and below knee surgeries.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  ASA 1 and ASA 2 
 
ExclusionCriteria 
Details  ASA 3 & 4
Refusal of consent
psychological and neurological disorder
coagulation disorder
infection at local site of injection
history of allergy to LA
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)Duration of post-operative analgesia.
2)Total dose of rescue analgesic required in first 24 hours.
3)VAS (Visual Analog Score) in 2, 4, 6, 12, 24 hours post-operatively.
 
2, 4, 6, 12, 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1)To analyze the incidences of complications, if any, associated with 4 in 1 block and Epidural Blocks
2)To assess the side effects of drugs used in the study
3)Length of hospital stay
 
2, 4, 6, 12, 24 hours 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 3/ Phase 4 
Date of First Enrollment (India)   01/05/2024 
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="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  

THESIS TITLE-

Novel vs Traditional :  comparison of 4-1 block vs epidural for post operative analgesic needs in knee and below knee surgeries.

Knee and below knee surgeries are associated with moderate to severe pain postoperatively leading to delayed recovery and  prolonged hospital stay. Therefore, this study is to compare two types of analgesia. Aim of our study is to compare post-operative analgesia and motor performance between 4-1 Block versus Continuous Epidural Block (CEB) in patients undergoing Knee and below Knee surgeries. Patient will be evaluated on primary outcomes such as duration of post-operative analgesia, total dose of rescue analgesic required in first 24 hours, VAS (Visual Analog Scale) score at  2, 4, 6, 12, 24 hours post-operatively .The secondary outcomes will be to analyze the incidence of complications if any, to assess the side effects of drug used and length of hospital stay. Total 80 patients will be taken and they will be divided randomly into 2 group of 40 each.

Group A-  4-1 BLOCK GROUP : After surgery, supine position is maintained and the vastus medialis muscle is identified by ultrasound. Then scanned proximally till the intersection of vastus and sartorius. Then the probe is slid proximally till the superficial femoral artery appears in the adductor hiatus.. The probe is then again slid slowly proximally till the descending genicular artery , a branch from superficial femoral artery is visualised in the adductor hiatus. Further proximally where descending genicular artery disappears is the point of injection. The point is 8-10 cm above the femoral condyle. Under all aseptic precautions, a 22 gauge, 360 ultrasound compatible 100 mm needle is guided in plane from lateral to medial side under ultrasound guidance to reach perivascular regions and after negative aspiration , 0.2% ropivacaine 35 ml along with 0.5 mcg/kg Dexmedetomidine is injected that is visualised to push the femoral artery posteriorly.

 

 Group B- EPIDURAL BLOCK GROUP : Non ultrasonographic guided Epidural block with bolus dose of 5ml 0.2% Ropivacaine with  0.5mcg/kg Dexmedetomidine will be given followed by the same dose and concentration of the drug as Continuous Epidural Block infusion at rate of 5ml/hour.

After the blocks, vital parameters will be monitored and recorded. Side effects will be observed, if any. Visual Analogue Scale score will be noted at 2, 4, 6, 12 & 24 hours. Length of hospital stay after the surgery will be noted. All the data will be recorded.

 
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