| 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
|
|
|
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
|
|
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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. |