| CTRI Number |
CTRI/2025/02/081384 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
24/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A prospective study comparing the efficacy and outcome of intraoperative periarticular cocktail infiltration with two different adjuvants in patients undergoing total knee arthroplasty |
|
Scientific Title of Study
|
A Prospective Randomised Double Blinded Study to compare the efficacy and outcome of intraoperative periarticular cocktail infiltration with Clonidine Vs Magnesium Sulphate and Sodium Bicarbonate in patients undergoing 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 Anurag Das |
| Designation |
Senior Resident(Academic) |
| Affiliation |
All India Institute of Medical Sciences, Patna |
| Address |
Department of Orthopaedics, AIIMS Patna, Phulwari Sharif, Patna-Aurangabad Road, Patna, Bihar-801507
Patna
BIHAR
801507
India |
| Phone |
8100979967 |
| Fax |
|
| Email |
anuragdas23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudeep Kumar |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, Patna |
| Address |
Department of Orthopaedics, AIIMS Patna, Phulwari Sharif, Patna-Aurangabad Road, Patna, Bihar-801507
Patna
BIHAR
801507
India |
| Phone |
9472232758 |
| Fax |
|
| Email |
drsudeepk@aiimspatna.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudeep Kumar |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, Patna |
| Address |
Department of Orthopaedics, AIIMS Patna, Phulwari Sharif, Patna-Aurangabad Road, Patna, Bihar-801507
Patna
BIHAR
801507
India |
| Phone |
9472232758 |
| Fax |
|
| Email |
drsudeepk@aiimspatna.org |
|
|
Source of Monetary or Material Support
|
| AIIMS Patna, Phulwari-Sharif, Patna-Aurangabad Road, Patna, Bihar-801507 |
|
|
Primary Sponsor
|
| Name |
AIIMS Patna |
| Address |
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 Anurag Das |
All India Institute of Medical Sciences, Patna |
Room number-44, Ground Floor, OPD Building, Department of Orthopaedics,AIIMS Patna,Phulwari Sharif , Patna-Aurangabad Road, Patna
Patna
BIHAR |
8100979967
anuragdas23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Patna Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Clonidine |
Inj Clonidine-150mcg/ml-1ml, intraoperative periarticular infiltration |
| Intervention |
Magnesium Sulphate
Sodium Bicarbonate |
Magnesium Sulphate-50%-2ml, intraoperative periarticular infiltration
Sodium Bicarbonate-8.4%,25ml,intraoperative periarticular infiltration
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Unilateral Total Knee Replacement |
|
| ExclusionCriteria |
| Details |
History of allergy to the medications used in the study,Patients undergoing extensive soft tissue release, Severe varus knees (HKA greater than 10), Inflammatory arthritis, Painful Hip pathology, Patients with intra-operative fractures, Previous history of steroid injection into the knee joint ,Patients undergoing revision surgery or any history of prior operation around the knee |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the post operative functional outcome in terms of pain relief and early mobilization of Clonidine as an adjuvant versus MgSO4 & NaHCO3 as an adjuvant in periarticular cocktail infiltration. |
VAS score at 2hours, 4 hours,6hours, 8 hours, 10hours, 12 hours,24 hours, 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Use of rescue analgesia in the form of Injection Tramadol (50 mg), intravenous and also the frequency of the requirement of rescue analgesia during the early post operative period(i.e. within POD 5), To assess ROM post operatively till the day of discharge(POD-5) |
ROM at POD-0,1,2,3,4,5 |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
10/03/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is a randomised ,double blinded, parallel group, single centre study. The estimated sample size for this study is 66. The patients will be divided into 2 groups containing 33 people in each group. Group 1 will be receiving Clonidine as an adjuvant with the periarticular cocktail whereas Group 2 will be receiving Magnesium Sulphate and Sodium Bicarbonate as an adjuvant. The primary objective is to compare the post operative functional outcome in terms of pain relief and early mobilisation (within 48hrs post-operatively) of Clonidine as an adjuvant versus MgSO4 & NaHCO3 as an adjuvant in periarticular cocktail infiltration. Secondary objective is use of rescue analgesia in the form of Injection Tramadol (50 mg), intravenous and also the frequency of the requirement of rescue analgesia during the early post operative period(i.e. within POD 5), and to assess ROM post operatively till the day of discharge(POD-5) .
|