| CTRI Number |
CTRI/2025/05/086105 [Registered on: 01/05/2025] Trial Registered Prospectively |
| Last Modified On: |
01/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
analgesic effect of ultrasound guided continuous adductor canal block with and without low concentration-sciatic nerve block by anterior approach in patients undergoing primary unilateral total knee arthroplasty |
|
Scientific Title of Study
|
Comparison of post operative analgesic effect of ultrasound guided continuous adductor canal block with and without low concentration-sciatic nerve block by anterior approach in patients undergoing primary unilateral total knee arthroplasty.
|
| 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 Namita Sharma |
| Designation |
Senior Consultant and HOD |
| Affiliation |
Aakash Healthcare Super Specialty Hospital |
| Address |
Aakash Healthcare Super Specialty Hospital
Hospital Plot Road No 201 Sector3 Dwarka New Delhi
department-anesthesia
division-anesthesia
room no-OT1
South West
DELHI
110075
India |
| Phone |
9899521048 |
| Fax |
|
| Email |
namita.sharma@aakashhealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namita Sharma |
| Designation |
Senior Consultant and HOD |
| Affiliation |
Aakash Healthcare Super Specialty Hospital |
| Address |
Aakash Healthcare Super Specialty Hospital
Hospital Plot Road No 201 Sector3 Dwarka New Delhi
department-anesthesia division-anesthesia
room no-OT1
DELHI
110075
India |
| Phone |
9899521048 |
| Fax |
|
| Email |
namita.sharma@aakashhealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Solunke |
| Designation |
DNB Resident |
| Affiliation |
Aakash Healthcare Super Specialty Hospital |
| Address |
Aakash Healthcare Super Specialty Hospital
Hospital Plot Road No 201 Sector3 Dwarka New Delhi
department-anesthesia
division-anesthesia
room no-OT1
DELHI
110075
India |
| Phone |
9899521048 |
| Fax |
|
| Email |
rash.solunke@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aakash Healthcare Super Specialty Hospital Dwarka sector 3, road no 201, New Delhi, India 110075 |
|
|
Primary Sponsor
|
| Name |
Aakash Healthcare Super Specialty Hospital |
| Address |
Hospital Plot Road No 201 Sector3 Dwarka New Delhi 110075 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Rashmi Solunke |
Aakash Healthcare Super Specialty Hospital |
Aakash Healthcare Super Specialty Hospital
department-anesthesia division-anesthesia room number-OT1
South West
DELHI |
8830287566
rash.solunke@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aakash Healthcare Super Specialty Hospital Institutional 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, (2) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Adductor canal block |
one year eight months |
| Intervention |
Sciatic nerve block and Adductor canal block
|
1.Sciatic nerve block
Dose-0.1% ropivacaine 15 ml
Frequency-Single shot
Route of Administration-Nerve Catheter
Duration-one year eight months
2. Adductor canal block
Dose-14 ml of 0.25%
bupivacaine with 4 mg of dexamethasone
Frequency-Qid (Four times a day)
Route of Administration-Nerve Catheter
Duration-one year eight months
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective primary unilateral TKA secondary to degenerative OA
Age between 40-65 years
Physical status of ASA I-III
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Pain score and reduction in requirement of rescue dosage of analgesics |
48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in requirement of rescue dosage of analgesics and quality of motor blockade |
48 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
10/05/2027 |
| 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="8"
Days="6" |
|
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
|
Comparison
Of Post Operative Analgesic Effect Of Ultrasound Guided Continuous Adductor
Canal Block With And Without Low Concentration-Sciatic Nerve Block by Anterior Approach
In Patients Undergoing Primary Unilateral Total Knee Arthroplasty.Primary objective of the study is to Assess postoperative
analgesia (NRS score) and secondary objective of the study is to assess Motor
Blockade ( Modified Bromage Scale ) |