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CTRI Number  CTRI/2026/01/102084 [Registered on: 27/01/2026] Trial Registered Prospectively
Last Modified On: 25/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Does intravenous dexamethasone decrease pain and complication rates in patients undergoing total knee replacement surgery? 
Scientific Title of Study   The effect of intravenous dexamethasone on postoperative pain management in patients undergoing unilateral total knee arthroplasty under subarachnoid block 
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 Mathew George 
Designation  Associate Professor 
Affiliation  Amrita Institute of Medical Sciences and Research Center,Kochi 
Address  Kodiyattil, Kadungallur Rd., Thottakattukara P.O., Aluva
Division of Orthopaedic and Neuroanaesthesia, Department of Anaesthesia, Amrita Institute of Medical Sciences and Research Center, Kochi
Ernakulam
KERALA
683108
India 
Phone  04844000514  
Fax  04842801234  
Email  mathew.doc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mathew George 
Designation  Associate Professor 
Affiliation  Amrita Institute of Medical Sciences and Research Center,Kochi 
Address  Kodiyattil, Kadungallur Rd., Thottakattukara P.O., Aluva
Division of Orthopaedic and Neuroanaesthesia, Department of Anaesthesia, Amrita Institute of Medical Sciences and Research Center,Kochi
Ernakulam
KERALA
683108
India 
Phone  04844000514  
Fax  04842801234  
Email  mathew.doc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Lahari Medisetty 
Designation  Resident 
Affiliation  Amrita Institute of Medical Sciences and Research Center,Kochi 
Address  Department of Anaesthesia, Amrita Institute of Medical Sciences and Research Center, AIMS PO, Kochi

Ernakulam
KERALA
682041
India 
Phone  9533010333  
Fax    
Email  laharimedisetty@gmail.com  
 
Source of Monetary or Material Support  
Amrita School of Medicine, AIMS PO, Ernakulam, Kerala, India 682041 
 
Primary Sponsor  
Name  Dr Prem Nair 
Address  Provost, Amrita Institute of Medical Sciences, Kochi, Kerala, India 682041 
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 Mathew George  Amrita Institute of Medical Sciences and Research Center, Kochi, Kerala, India PIN 682041  Orthopaedic operating suite, Amrita Institutue of Medical Sciences and research center, AIMS PO, Edapally, Ernakulam, Kerala India PIN 682041
Ernakulam
KERALA 
9447841795

mathew.doc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, Amrita School of Medicine  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  Intravenous dexamethasone 0.1mg/kg  2 doses of 0.1 mg/kg of intravenous dexamethosone bolus given over 10 seconds, perioperatively to patients undergoing total knee arthroplasty under spinal anaesthesia. First dose immediately before induction of anaesthesia, and the second dose after 8 hours 
Comparator Agent  Placebo  5 ml of normal saline given as intravenous bolus over 10 seconds, before induction of anaesthesia, and repeated after 8 hours 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  All patients undergoing elective unilateral primary total knee arthroplasty. 
 
ExclusionCriteria 
Details  Patients less than 18 years of age or more than 90 years of age
uncontrolled diabetics 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Decreased analgesic requirements as assessed by perioperative opioid consumption  Decreased analgesic requirements as assessed by perioperative opioid consumption over the first 48 hours following surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Post-opertive nausea and vomiting  Assessed at 48 hours postoperatively 
 
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)   17/02/2026 
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="0"
Months="6"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  requestors will need to email the PI at mathewgeorge@aims.amrita.edu and the de-identified data shall be shared over a onedrive link

  6. For how long will this data be available start date provided 01-11-2026 and end date provided 01-11-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Patients will be randomly allocated to either of the two groups [ Group D or Group P] using computer generated random sequence of numbering. Concealment of allocation will be ensured by sequentially numbered opaque sealed envelopes.                                         On the day of surgery, patients in Group D will receive 0.1mg/kg Dexamethasone (rounded up to the nearest milligram dose) diluted up to 5 ml with normal saline before performance of spinal anaesthesia, whereas Group P will receive 5ml of normal saline. The drug will be administered by the posted anaesthetist in the OR immediately following establishment of IV access. All standard monitors will be attached and baseline HR, SBP, MAP will be recorded. Blood sugars will be checked using GRBS before administration of spinal anaesthesia and at 2 hourly intervals intraoperatively. All patients will receive spinal anaesthesia with bupivacaine 0.5%(H) 3ml + fentanyl 25mcg (0.5ml). After confirming adequate blockade, patient will be positioned for surgery. At the end of surgery under aseptic precautions and USG guidance adductor canal block will be given with ropivacaine 0.2% 20 ml and catheter placed. Post operatively Group D will receive another dose of dexamethasone 0.1mg/kg (rounded upto the nearest milligram dose) diluted up to 5 ml, 8 hours after the initial dose whereas group P will receive 5ml of normal saline. The study drug as well as placebo will be loaded in a 5ml unlabelled syringe (by the operating room anaesthetist) labelled as study drug and administered by the ICU anaesthetist. Both the ICU anaesthetist and the staff nurse will be blinded to the study group. All patients will receive IV paracetamol 1-gram IV TID along with buprenorphine patch 10mg.

Patients will receive IV fentanyl or morphine as rescue analgesic as decided by the duty anaesthetist to keep the VAS score below 4. The cumulative opioid consumption for each patient for the first 48 hours after surgery will be recorded as morphine equivalents.

Other perioperative complications documented will be –

Post operative Nausea and vomiting using simplified PONV impact scale.

Significant PONV will be managed by IV ondansetron 0.1mg/kg Q8h

Incidence of post operative pruritus and hyperglycaemia (sugars more than 180 mg% on two consecutive occasions post-operatively)

Hyperglycaemia postoperatively will be managed with delta protocol insulin infusions as routinely prescribed along with previously prescribed oral hypoglycaemics as directed by the ICU anaesthetist.

Wound issues (healing / as assessed by the surgical team at discharge will also be documented.

 
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