| CTRI Number |
CTRI/2024/09/074119 [Registered on: 20/09/2024] Trial Registered Prospectively |
| Last Modified On: |
12/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pain management after knee replacement surgery- comparison between two techniques ( nerve blocks) |
|
Scientific Title of Study
|
Comparison of dual subsartorial block and triple injection perisartorius block in combination with local infiltration analgesia for management of pain following Total Knee Arthroplasty- Single centre, double blind,randomised study |
| 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 Tamalika Das |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
The Mission Hospital |
| Address |
The Mission Hospital
Immon Kalyan Sarani
Sector IIC
Bidhan Nagar
Durgapur
Paschim Bardhaman
West Bengal
Barddhaman
WEST BENGAL
713212
India |
| Phone |
9843540735 |
| Fax |
|
| Email |
tamalika19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tamalika Das |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
The Mission Hospital |
| Address |
The Mission Hospital
Immon Kalyan Sarani
Sector IIC
Bidhan Nagar
Durgapur
Paschim Bardhaman
West Bengal
Barddhaman
WEST BENGAL
713212
India |
| Phone |
9843540735 |
| Fax |
|
| Email |
tamalika19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tamalika Das |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
The Mission Hospital |
| Address |
The Mission Hospital
Immon Kalyan Sarani
Sector IIC
Bidhan Nagar
Durgapur
Paschim Bardhaman
West Bengal
Barddhaman
WEST BENGAL
713212
India |
| Phone |
9843540735 |
| Fax |
|
| Email |
tamalika19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
Pac room
3rd floor
The Mission Hospital
Immon Kalyan Sarani
Sector IIC
Bidhan Nagar
Durgapur 713212
Paschim Bardhaman
West Bengal
India |
|
|
Primary Sponsor
|
| Name |
Dr Tamalika Das |
| Address |
Department of Anaesthesiology
Pac room
3rd floor
The Mission Hospital
Immon Kalyan Sarani
Sector IIC
Bidhan Nagar
Durgapur 713212
Paschim Bardhaman
West Bengal
India |
| Type of Sponsor |
Other [self] |
|
|
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 Tamalika Das |
The Mission Hospital |
Department of Anaesthesiology
Pac room
3rd floor
Immon Kalyan Sarani
Sector IIC
Bidhan Nagar
Durgapur 713212
Paschim Bardhaman
West Bengal
India
Barddhaman
WEST BENGAL |
9843540735
tamalika19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Mission Hospital Ethics Committee |
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 |
Dual sub sartorial block |
Ultrasound guided dual sub sartorial block will be given once after the surgery along with local infiltration analgesia |
| Intervention |
Triple injection perisartorius block |
Ultrasound guided triple injection perisartorius block will be given once after the surgery along with local infiltration analgesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA PS -I, II
Primary unilateral TKA via medial parapatellar approach by a single surgeon done under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
Patient refusal or unable to give consent
Contraindication to regional anaesthesia
Patients with advanced cardiac and respiratory insufficiency
Known allergy to any of the drugs in the study
Revision/complex TKA, bilateral TKA
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS score |
4 8 12 24 36 48 hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time to receive first rescue analgesia
Quadriceps muscle power
Ambulation
Side effects
Patient satisfaction
length of hospital stay |
after surgery |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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
|
N/A |
|
Date of First Enrollment (India)
|
27/09/2024 |
| 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="0"
Months="2"
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
|
In the proposed study the effectiveness of dual sub sartorial block and triple injection peri sartorius block for total knee arthroplasty will be compared. This study will be of great significance to select an appropriate analgesic model for Peri operative pain management of total knee arthroplasty. |