| CTRI Number |
CTRI/2024/11/076582 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
05/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Other (Specify) [ALTERATION OF INTRA OPERATIVE TOURNIQUET PRESSURE] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of different touniquet pressure used during surgery,on post operative outcome after total knee replacement |
|
Scientific Title of Study
|
A randomized controlled trial on the effect of different intraoperative tourniquet pressure on postoperative pain and complications after total knee replacement |
| 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 Arijit Keshri |
| Designation |
Junior Resident,Department of Orthopaedics,AIIMS Patna |
| Affiliation |
AIIMS PATNA |
| Address |
Department of Orthopaedics,OPD Building,AIIMS Patna,Aurangabad Rd, Phulwari Sharif, Patna, Bihar 801507
Patna
BIHAR
801507
India |
| Phone |
9051437987 |
| Fax |
|
| Email |
arijit.keshri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.(Prof.) Sudeep Kumar |
| Designation |
Professor and Unit Head,Department of Orthopaedics,AIIMS Patna |
| Affiliation |
AIIMS PATNA |
| Address |
Room no.48,Department of Orthopaedics,OPD Building,AIIMS Patna,Aurangabad Rd, Phulwari Sharif, Patna, Bihar 801507
Patna
BIHAR
801507
India |
| Phone |
7765065667 |
| Fax |
|
| Email |
drsudeepk@aiimspatna.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arijit Keshri |
| Designation |
Junior Resident,Department of Orthopaedics,AIIMS Patna |
| Affiliation |
AIIMS PATNA |
| Address |
Department of Orthopaedics,OPD Building,AIIMS Patna,Aurangabad Rd, Phulwari Sharif, Patna, Bihar 801507
Patna
BIHAR
801507
India |
| Phone |
9051437987 |
| Fax |
|
| Email |
arijit.keshri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthopaedics,AIIMS Patna,Aurangabad Rd, Phulwari Sharif, Patna, Bihar,India
Pincode-801507 |
|
|
Primary Sponsor
|
| Name |
All India Institute of medical sciences, Patna |
| Address |
Aurangabad Rd,Phulwari Sharif,Patna,Bihar 801507 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arijit Keshri |
AIIMS Patna |
Room number 48,Deparment of Orthopaedics,OPD Buiulding,AIIMS Patna,Aurangabad Rd, Phulwari Sharif, Patna, Bihar,India
Pincode-801507
Patna
BIHAR |
9051437987
arijit.keshri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee All India Institute of Medical Sciences, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intraoperative tourniquet pressure |
Randomly assigned tourniquet pressure groups as-
1.Tourniquet pressure group 1-Systolic Blood Pressure+100mmhg.
2.Tourniquet pressure group 2-Systolic Blood Pressure+120mmhg. |
| Intervention |
Intraoperative tourniquet pressure |
Randomly asssigned tourniquet presssure group as
Tourniquet pressure-Systolic Blood Pressure+80mmhg |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with OA knee planned for primary TKR (any side)in AIIMS PATNA
2.Age group 18 and above
3.Consenting participants
|
|
| ExclusionCriteria |
| Details |
1.Revision TKR.
2.Preop blood transfusion within 24hrs (PRBC only)
3.Evidence of recent Venous thromboembolism.
4.Contraindications for tourniquet use ( graft, peripheral vascular disease, calcified popliteals in xrays etc), cases where tourniquet is not used.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
VAS score for pain
|
1.24hrs
2.48hrs
3.1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Knee Range of motion and VAS score for pain will be assessed 7 days after surgery. |
1.Knee Range of motion and VAS score for pain will be assessed 7 days after surgery. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
19/11/2024 |
| 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="2"
Months="6"
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
|
Study is being done to compare the
functional outcome in terms of VAS score for pain at surgical site and thigh pain at 24 hrs, 48hrs and 1 week
following TKR , between tourniquet pressures SBP+100mmHg,SBP+120mmHg and
SBP+80mmHg. It will also help to
determine bloodless operative field at tibial and femoral cutting
surface in terms
of score(3 being best visibility and 2 being worst).
Secondary Objectives:
To evaluate
the following and compare between the above mentioned groups- 1.Change in haemoglobin,48 hours after the
procedure and estimated blood loss
2.Wound complications (wound ooze, infection), and skin complications of
the operated limb (hematoma, blister or bleb), to be assessed 48hrs after
surgery. 3. At 48 hours after TKR, level of total creatinine phosphokinase
(CPK) concentration.
4.
Knee ROM (Range of motion) before and 7 days post-surgery.
|