| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan
- 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.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- 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
- 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.
- 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.
|