| CTRI Number |
CTRI/2025/03/082281 [Registered on: 13/03/2025] Trial Registered Prospectively |
| Last Modified On: |
12/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Investigating the Efficacy of Low Dose Steroids in Reducing Postoperative Pain and Improving Sleep Quality Following Primary Total Knee Arthroplasty: A Randomized Controlled Trial |
|
Scientific Title of Study
|
Investigating the Efficacy of Low Dose Steroids in Reducing Postoperative Pain and Improving Sleep Quality Following Primary Total Knee Arthroplasty: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Soundarrajan D |
| Designation |
Associate consultant |
| Affiliation |
Ganga hospital |
| Address |
OPD 5,
Department of Orthopaedics- Arthroplasty unit, B block, Ganga hospital, 313, Mettupalayam road,
Coimbatore
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9994462230 |
| Fax |
|
| Email |
soundarortho@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Soundarrajan D |
| Designation |
Associate consultant |
| Affiliation |
Ganga hospital |
| Address |
OPD 5, Department of Orthopaedics- Arthroplasty unit, B block, Ganga hospital, 313, Mettupalayam road,
Coimbatore
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9994462230 |
| Fax |
|
| Email |
soundarortho@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Soundarrajan D |
| Designation |
Associate consultant |
| Affiliation |
Ganga hospital |
| Address |
OPD 5, Department of Orthopaedics- Arthroplasty unit, B block, Ganga hospital, 313, Mettupalayam road,
Coimbatore
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9994462230 |
| Fax |
|
| Email |
soundarortho@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ganga hospital,
B block,
Department of Orthopaedics, 313, Mettupalayam road, Coimbatore, Tamil nadu state, India- 641 043 |
|
|
Primary Sponsor
|
| Name |
Ganga hospital |
| Address |
B block, 313, Mettupalayam road,
Ganga hospital,
Coimbatore |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Soundar rajan D |
Ganga hospital |
OPD 5, Department of Orthopaedics- Arthroplasty unit, B block, Ganga hospital, 313, Mettupalayam road,
Coimbatore
Coimbatore
TAMIL NADU |
9994462230
soundarortho@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ganga Institutional review board |
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 |
| Intervention |
Tablet Deflazocort |
The intervention group receive low-dose steroids (Deflazacort 6mg orally) once daily for 3 weeks postoperatively |
| Comparator Agent |
Vitamin B complex tablet |
The control group will receive the B complex tablet. It will be given once daily orally for 3 weeks postoperatively |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
adult patients aged 45-80 years with a diagnosis of advanced knee osteoarthritis requiring total knee arthroplasty |
|
| ExclusionCriteria |
| Details |
Exclusion criteria will include patients with rheumatoid arthritis, contraindications to steroid use, history of chronic steroid therapy, and significant comorbidities impacting pain perception and sleep quality. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To assess the effectiveness of low-dose steroids in reducing postoperative pain and local warmth following primary TKA.
2) To evaluate the impact of low-dose steroids on sleep quality in the postoperative period after primary TKA. |
At baseline preoperatively, postoperative day 3, 1 month, 3 months and 6 months postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine any adverse effects associated with the use of low-dose steroids in this patient population. |
At baseline preoperatively, postoperative day 3, 1 month, 3 months and 6 months postoperatively. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/04/2025 |
| 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)
|
Open to Recruitment |
| 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
|
Total knee arthroplasty (TKA) is a common surgical procedure for patients with advanced knee arthritis. Despite advancements in surgical techniques and postoperative care, pain management remains a significant challenge in the immediate postoperative period. Sleep disturbances are also prevalent following TKA, further impacting patients’ recovery and overall well-being. This randomized controlled trial (RCT) aims to evaluate the potential benefits of low-dose steroids in reducing postoperative pain and improving sleep quality among patients undergoing primary TKA. Eligible participants will be randomized into two groups, 50 patients in each arm: the intervention group receiving low-dose steroids (Deflazacort 6mg orally) for 3 weeks postoperatively and the control group receiving placebo. Both groups will receive standard perioperative pain management protocols. The warmth over the knee will be analysed using Thermographic camera. Inflammatory parameters will be analysed using erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and Interleukin-6 (IL-6). Pain scores will be assessed using a standardized pain scale (e.g., Visual Analog Scale) at regular intervals postoperatively. Sleep quality will be assessed using validated sleep questionnaires (e.g., Pittsburgh Sleep Quality Index). We hypothesize that patients receiving low-dose steroids will experience lower postoperative pain scores, reduced warmth and improved sleep quality compared to those receiving placebo. Positive outcomes from this study could lead to the implementation of low-dose steroid therapy as a standard adjunctive treatment in the postoperative management of patients undergoing primary TKA, potentially improving overall patient satisfaction and enhancing recovery. This randomized controlled trial aims to investigate the efficacy of low-dose steroids in reducing postoperative pain and improving sleep quality following primary TKA. By addressing these critical aspects of postoperative care, this study has the potential to contribute valuable insights to optimize patient outcomes and enhance the quality of care in this patient population.
|