| CTRI Number |
CTRI/2026/03/105355 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
04/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study on Patients Undergoing Knee Replacement to See Whether Injecting Pain Medicine into the Bone During Surgery Reduces Pain After the Operation |
|
Scientific Title of Study
|
Comperative Evaluation of Intraosseous Regional Analgesia using Diclofenac, Morphine, Lignocaiine and placebo in Bilateral Total Knee Arthroplasty: A Prospective 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 |
Dr Khushwant Meena |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
PGIMER chandigarh |
| Address |
Dept of orthopedics surgery, block b , nehru hospital PGIMER, sector 12 madhya marg chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09950039044 |
| Fax |
|
| Email |
khushwantmeena2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikas Bachhal |
| Designation |
Additional professor |
| Affiliation |
PGIMER chandigarh |
| Address |
Dept. of orthopedics PGIMER chandigarh
PGIMER CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087928664 |
| Fax |
|
| Email |
vikasbachhal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikas Bachhal |
| Designation |
Additional professor |
| Affiliation |
PGIMER chandigarh |
| Address |
Dept. of orthopedics PGIMER chandigarh
PGIMER CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087928664 |
| Fax |
|
| Email |
vikasbachhal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of orthopedics surgery, block b , nehru hospital PGIMER, sector 12 madhya marg 160012, chandigarh, india |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 Khushwant Meena |
Department of orthopedics PGIMER CHANDIGARH |
BLOCK B NEHRU HOSPITAl , PGIMERR sector 12, 160012 , chandigarh
Chandigarh
CHANDIGARH |
09950039044
khushwantmeena2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instt. Ethics Commitee ( intramural ) PGIMER, CHANDIGARH |
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 |
Evaluation of Intraosseous Regional Analgesia in Bilateral Total Knee Arthroplasty
|
Intraosseous Regional Analgesia (IO RA) will be administered into the proximal tibia of patients undergoing Bilateral Total Knee Arthroplasty. Each limb will receive a single intraosseous injection of Diclofenac sodium 75 mg, Morphine 5 mg, and Lignocaine 2% 2mg/kg , diluted with normal saline to a total volume of 10 mL and 10ml normal saline as control after tourniquet inflation and before surgical incision.
follow up for 48 hours after the surgery |
| Comparator Agent |
Evaluation of Intraosseous Regional Analgesia in Bilateral Total Knee Arthroplasty |
Intraosseous Regional Analgesia (IO RA) will be administered into the proximal tibia of patients undergoing Bilateral Total Knee Arthroplasty. Each limb will receive a single intraosseous injection of Diclofenac sodium 75 mg, Morphine 5 mg, and Lignocaine 2% 2mg/kg , diluted with normal saline to a total volume of 10 mL and 10ml normal saline as control after tourniquet inflation and before surgical incision
follow up for 48 hours after the surgery |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged 50–75 years undergoing simultaneous bilateral total knee arthroplasty under spinal anesthesia and epidural analgesia
Diagnosed with bilateral end-stage osteoarthritis of the knee
ASA (American Society of Anesthesiologists) physical status Class I–III
Willing and able to provide informed written consent |
|
| ExclusionCriteria |
| Details |
Known allergy or hypersensitivity to lignocaine, morphine, diclofenac, or other
NSAIDs
Patients with coagulopathy or on anticoagulants that cannot be discontinued
History of chronic opioid use, substance abuse, or opioid tolerance
Renal or hepatic impairment
Active local or systemic infection
History of neurological disorders or psychiatric illness affecting pain perception or communication
Revision TKA or prior major surgery on either knee
If surgery went prolonged more then 4 hrs
If during surgery any intraop complication happens.
if patient having rhematoid arthritis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the total opioid consumption (in morphine equivalents) in the first 48 hours postoperatively among the four groups. |
To compare the total opioid consumption (in morphine equivalents) in the first 48 hours postoperatively among the four groups. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate & compare the postoperative pain relief provided by intraosseous administration of Diclofenac, Morphine, Lignocaine & Control using standardized pain scores (e.g., Visual Analog Scale) at 6, 12, 24 & 48hrs predefined time intervals.
To evaluate the time to first rescue analgesia postoperatively among the four groups.
To monitor & compare the incidence of adverse effects (e.g., nausea, vomiting, sedation, allergic reactions, local complications). |
after 48 hrs over the course of the study |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
16/03/2026 |
| 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 Phase 2 randomized controlled trial evaluates the efficacy and safety of intraosseous regional analgesia using morphine, lignocaine, and diclofenac in patients undergoing bilateral total knee arthroplasty. Postoperative pain intensity (VAS) and total opioid consumption will be assessed up to 48 hours. The study aims to determine whether this technique provides effective pain control with minimal adverse effects, potentially improving postoperative recovery. |