| CTRI Number |
CTRI/2026/02/103330 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
08/02/2026 |
| 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
|
To study the effect of adding single dose morphine to epidural 0.2 percent ropivacaine injection for the management of pain following knee arthroplasty |
|
Scientific Title of Study
|
To study the effect of adding single dose morphine to epidural 0.2 percent ropivacaine injection for the management of pain following 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 Sandeep Kundra |
| Designation |
Professor Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia, Dayanand Medical College and Hospital,
Civil Lines Ludhiana
Ludhiana PUNJAB 141001 India |
| Phone |
9815608241 |
| Fax |
|
| Email |
sandeepkundra07@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Amisha Gupta |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia ,Dayanand Medical College and Hospital,
Civil Lines Ludhiana
Ludhiana PUNJAB 141001 India |
| Phone |
9877366396 |
| Fax |
|
| Email |
amishagupta.dr99@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Amisha Gupta |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia ,Dayanand Medical College and Hospital,
Civil Lines Ludhiana
Ludhiana PUNJAB 141001 India |
| Phone |
9877366396 |
| Fax |
|
| Email |
amishagupta.dr99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Medical College and Hospital Tagore Nagar, Civil lines, Ludhiana 141001 Punjab |
|
|
Primary Sponsor
|
| Name |
Dayanand Medical college and Hospital |
| Address |
Tagore Nagar, Civil lines, Ludhiana. 141001 Punjab India |
| Type of Sponsor |
Private 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 Sandeep Kundra |
Dayanad Medical College and Hospital |
Department of
Anaesthesiology, Dayanand
Medical College and
Hospital ,Tagore Nagar,
Civil Lines Ludhiana
141001
Punjab Ludhiana PUNJAB |
9815608241
sandeepkundra07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and ethical committee , Dayanand medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Evaluate analgesic efficacy of epidural morphine when added to 0.2 % ropivaciane for management of pain following total knee arthroplasty. |
Group A – 3mg morphine added to 0.2% ropivacaine to make a total of 6ml will be administered in epidural space through epidural catheter.
Duration - 1 year |
| Comparator Agent |
Evaluate analgesic efficacy of epidural morphine when added to 0.2 % ropivaciane for management of pain following total knee arthroplasty. |
Group B – 0.3ml normal saline added to 0.2% ropivacaine to make a total of 6ml will be administered in epidural space through epidural catheter.
Duration- 1 year |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I to grade III |
|
| ExclusionCriteria |
| Details |
1. Any contraindication to neuraxial blockade
2. Allergy or hypersensitivity to morphine or local anesthetics
3. History of chronic opioid use or substance abuse
4. Significant respiratory disease (e.g. severe chronic obstructive pulmonary disease or sleep apnea)
5. Renal insufficiency requiring dialysis
6. Severe hepatic impairment
7. Inability to use the numeric pain rating scale e.g. cognitive impairment or language barrier
8. Patients with high body mass index
9. ASA grade IV and higher |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total rescue analgesia consumption in 24 hours |
Patient will be observed at the time of administration of the study drug , then every hourly till 4 hours and then every hourly till 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative pain scores as assessed by NRS |
Patient will be observed at the time of administration of the study drug , then every hourly till 4 hours and then every hourly till 24 hours |
|
|
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)
|
23/02/2026 |
| 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="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
|
Total knee arthroplasty is associated with significant postoperative pain, which can delay rehabilitation and prolong hospital stay if inadequately managed. Epidural analgesia is commonly used after TKA, and addition of opioids such as morphine may enhance analgesic efficacy. This prospective, randomized, double-blind study will be conducted on 62 adult patients, ASA physical status I–III, scheduled for unilateral TKA under combined spinal–epidural anaesthesia . These patients will be enrolled and randomly allocated into two equal groups. All patients will receive continuous epidural infusion of 0.2% ropivacaine for 24 hours postoperatively. After 24 hours, patients in Group A will receive a single epidural dose of morphine 3 mg added to 0.2% ropivacaine ,total volume 6 ml , while Group B will receive normal saline added to 0.2% ropivacaine total volume 6 ml. The epidural catheter will then be removed. Postoperative monitoring will include vital parameters, numeric rating scale (NRS) pain scores, and rescue analgesic consumption for 24 hours following the epidural injection. The primary outcome is total rescue analgesic consumption over 24 hours. The secondary outcome is postoperative pain intensity assessed using the NRS. |