FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/05/019307 [Registered on: 24/05/2019] Trial Registered Prospectively
Last Modified On: 22/05/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of pain reief with two different doses of the drug dexmedetomidine used in nerve block following one sided knee replacement surgery. 
Scientific Title of Study   Comparison of different doses of dexmedetomidine as an adjuvant to ropivacaine in adductor canal block for post-operative analgesia following unilateral total knee replacement surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr S Gokul Das 
Designation  Clinical Professor 
Affiliation  Amrita Institute of Medical sciences 
Address  Department of Anaesthesiology and Critical Care Amrita Institute of medical sciences Ernakulam

Ernakulam
KERALA
682041
India 
Phone  9847448005  
Fax    
Email  gokuldas75@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr S Gokul Das 
Designation  Clinical Professor 
Affiliation  Amrita Institute of Medical sciences 
Address  Department of Anaesthesiology and Critical Care Amrita Institute of medical sciences Ernakulam

Ernakulam
KERALA
682041
India 
Phone  9847448005  
Fax    
Email  gokuldas75@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Naveen Karthik M 
Designation  PG Resident 
Affiliation  Amrita Institute of Medical sciences 
Address  Department of Anaesthesiology and Critical Care Amrita Institute of medical sciences Ernakulam

Ernakulam
KERALA
682041
India 
Phone  9840307152  
Fax    
Email  naveen.gm92@gmail.com  
 
Source of Monetary or Material Support  
Amrita institute Of Medical Sciences Amrita hospital Ernakulam 682041 
 
Primary Sponsor  
Name  Department Funds 
Address  Amrita Institute of medical science  
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 Gokul das  Amrita hospital  Operation theatre 17 Department of Anaesthesiology and critical care
Ernakulam
KERALA 		 9847448005

gokuldas75@hotmail.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: M171||Unilateral primary osteoarthritisof knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Addcutor Canal Block  Comparing different doses of dexmedetomidine ( 0.5mcg/kg and 1mcg/kg ) added to 0.2% ropivacaine 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1.Patient aged 18-85 years
2.ASA I , II & III
 
 
ExclusionCriteria 
Details  1)Patients refusal
2)Allergic to local anaesthetic
3)Patient on B Blockers and a agonist
4)Previously operated knee surgery
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the analgesic efficacy of dexmedetomidine 0.5mcg/kg versus 1mcg/kg as an adjuvant to 0.2% ropivacaine in adductor canal block in patients undergoing unilateral total knee replacement surgery  Pain Score Post-operatively every 30 min for 2 hours and 4th hourly for 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1)To assess the duration of analgesia.
2)To compare motor blockade postoperatively.
3)Postoperative sedation score.
4)24 hour rescue analgesic consumption
 		 Postoperatively 30min for 2 hours and 4th hourly for 24 hours 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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 2 
Date of First Enrollment (India)   01/06/2019 
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="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Total knee replacement surgery is a commonly performed orthopaedic surgery in the elderly age. Total knee replacement surgery causes immense post-operative pain. Multimodal analgesia is opted to facilitate pain relief , early ambulation and rehabilitation. Adductor canal block(ACB) is currently practised for post-operative pain relief following TKR. Studies have shown that adductor canal block provides better analgesia and superior quadriceps strength compared with femoral nerve block . Adductor canal block predominantly affects the 2 sensory branches of femoral nerve namely the saphenous nerve and the nerve to vastus medialis and part of articular branches of obturator nerve. ACB minimally affects the quadriceps muscles thus helping in early ambulation and rehabilitation.
Ropivacaine is a long-acting amide local anaesthetic agent. Ropivacaine has a greater degree of motor sensory differentiation, which could be useful when motor blockade is undesirable. The reduced lipophilicity is also associated with decreased potential for central nervous system toxicity and cardiotoxicity. Alpha 2 adrenergic agonists have both analgesic and sedative properties when used as an adjuvant in regional anaesthesia. Dexmedetomidine is a highly selective α2-adrenoreceptor agonist with sedative and analgesic effects. It enhances local anaesthetic effect without producing side effects, which makes it a good adjuvant to local anaesthetics. When compared to other sedatives, it produces sedation without significant respiratory compromise even at high doses.
 
Close