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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  
Name  Address 
Nil  Nil 
 
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  
Status 
Not Applicable 
 
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.
 
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