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CTRI Number  CTRI/2016/01/006569 [Registered on: 27/01/2016] Trial Registered Retrospectively
Last Modified On: 07/01/2016
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 effects of total intravenous anaesthesia (general anaesthesia) versus subarachnoid block (spinal anaesthesia) for total knee replacement on postoperative recovery profile and time to readiness for discharge 
Scientific Title of Study   Total intravenous anaesthesia versus subarachnoid block in unilateral total knee arthroplasty: A comparison of recovery profile and time to readiness for discharge  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bharathram V 
Designation  Junior Resident - Anaesthesiology 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Anaesthesiology,Pain medicine and Critical Care All India Institute of Medical Sciences Ansari Nagar New Delhi

South
DELHI
110029
India 
Phone  9968966371  
Fax    
Email  drbharathram@yahoo.in  
 
Details of Contact Person
Scientific Query
 
Name  Prof Anjan Trikha 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Anaesthesiology,Pain medicine and Critical Care All India Institute of Medical Sciences Ansari Nagar New Delhi

South
DELHI
110029
India 
Phone  9869397801  
Fax    
Email  anjantrikha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bharathram V 
Designation  Junior Resident - Anaesthesiology 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Anaesthesiology,Pain medicine and Critical Care All India Institute of Medical Sciences Ansari Nagar New Delhi

South
DELHI
110029
India 
Phone  9968966371  
Fax    
Email  drbharathram@yahoo.in  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  All India Institute of Medical Sciences Ansari Nagar New Delhi 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Prof Anjan Trikha  Department of Anaesthesiology, Pain Medicine and Critical Care All India Institute of Medical Sciences New Delhi 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bharathram V  All India Institute of Medical Sciences  Room no 5011, 5th floor, Department of Anaesthesiology, Pain medicine and Critical care All India Institute of Medical Sciences Ansari Nagar New Delhi
South
DELHI 
9968966371

drbharathram@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee/Ethical sub-committee, All India Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ASA physical status 1-3 patients undergoing unilateral total knee replacement surgery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Subarachnoid block  subarachnoid block with 3 ml of 0.5% hyperbaric bupivacaine and local infiltration at the end of surgery with a 40ml solution of 0.5% ropivacaine (37 ml containing 200mg) with 2µg/kg clonidine (1ml) and 5µg/ml or 1:200000 epinephrine (2ml of 100µg/ml). 
Intervention  Total intravenous anaesthesia   total intravenous general anaesthesia with propofol and fentanyl infusion and local infiltration at the end of surgery with a 40ml solution of 0.5% ropivacaine (37 ml containing 200mg) with 2µg/kg clonidine (1ml) and 5µg/ml or 1:200000 epinephrine (2ml of 100µg/ml). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Patients willing to undergo elective, primary, unilateral total knee arthroplasty under general or spinal anaesthesia, with age 18 – 85 years and belonging to American Society of Anesthesiologists Physical Status (ASA PS) I – III  
 
ExclusionCriteria 
Details  1. Patient’s refusal to take part in the study
2. Bilateral / Revision total knee arthroplasty
3. Morbid obesity (BMI ≥ 40 )
4. History of allergy to the drugs used in the study
5. History of regular opioid use
6. Contraindications to spinal anesthesia
7. Inability to understand information regarding Visual Analogue Scale
8. Inability to understand the use of patient controlled analgesia device
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Time to readiness for discharge as measured by the proportion of patients in each group meeting the discharge readiness criteria on subsequent postoperative days, with assessment starting from day 2 onwards  Everyday from postoperative day 2 onwards till discharge criteria is met 
 
Secondary Outcome  
Outcome  TimePoints 
postoperative opioid consumption and postoperative recovery profile - postoperative pain, urinary retention, nausea and vomiting  first 24 hours postoperatively 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/01/2014 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The ideal anaesthetic technique for total knee arthroplasty(TKA) remains controversial with previous studies showing varied results. Though the superiority of neuraxial anaesthesia over general anaesthesia in terms of postoperative recovery, morbidity and mortality has been demonstrated in several earlier studies, recent studies evaluating modern general anaesthetic techniques like target controlled infusion have shown faster and better recovery with GA, especially when used in conjunction with multi-modal analgesia and accelerated rehabilitative regimens. While neuraxial blockade is largely considered safe, it is not without risks – it is invasive and although rare, does have the potential for spinal haematoma, infection, abscess, and nerve damage. Neuraxial blockade has also been reported to be associated with adverse cardiovascular outcomes in patients who are already at high risk for increased cardiovascular morbidity. Patients’ preference for general anaesthesia when compared to regional techniques has been shown in a few studies. A systematic review by Macfarlane et al evaluating contemporary studies comparing regional and general anaesthesia failed to demonstrate clear cut benefits of neuraxial anaesthesia over general anaesthesia for the intraoperative management of TKA.

Thus, there is a lack of consensus regarding the best method of anaesthesia for patients undergoing TKA and further studies are required to investigate the different anaesthetic techniques, including total intravenous anaesthesia, for patients undergoing TKA. This study was initiated to compare the time to readiness for discharge and the postoperative recovery profile after total intravenous general anaesthesia or subarachnoid block for unilateral total knee arthroplasty.

 
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