FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/04/083893 [Registered on: 02/04/2025] Trial Registered Prospectively
Last Modified On: 25/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   This study looks at whether giving a single dose (8 mg through an IV) of the steroid dexamethasone before surgery can help reduce pain and the need for painkillers after percutaneous nephrolithotomy (a minimally invasive surgery to remove kidney stones) 
Scientific Title of Study   Effect Of Preoperative Single Dose 8Mg Intravenous Dexamethasone On Postoperative Pain And Blood Sugar Levels In Patients Undergoing Percutaneous Nephrolithotomy A Double Blind Randomised Control 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  Keerthi sudheer kumar  
Designation  Junior resident 
Affiliation  NIZAMS INSTITUTE OF MEDICAL SCIENCES  
Address  Department of Anesthesiology, Nizams Institute of medical sciences, Punjagutta, Hyderabad.

Hyderabad
TELANGANA
500082
India 
Phone  9705553608  
Fax    
Email  sudheerkeerthi98@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Monu balbir 
Designation  Professor 
Affiliation  Nizams institute of medical sciences 
Address  Department of Anesthesiology, Nizams Institute of medical sciences, Panjagutta, Hyderabad.

Hyderabad
TELANGANA
500082
India 
Phone  9490213460  
Fax    
Email  monubalbir@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Monu balbir 
Designation  Professor 
Affiliation  Nizams institute of medical sciences 
Address  Department of Anesthesiology, Nizams Institute of medical sciences, Panjagutta, Hyderabad.

Hyderabad
TELANGANA
500082
India 
Phone  9490213460  
Fax    
Email  monubalbir@yahoo.co.in  
 
Source of Monetary or Material Support  
Nizams institute of medical sciences, Punjagutta, Hyderabad, Telangana, India, pincode:500082 
 
Primary Sponsor  
Name  Nizams institute of medical sciences  
Address  Nims hospital, Punjagutta, 500082, Telangana Hyderabad  
Type of Sponsor  Research institution and hospital 
 
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 
Keerthi sudheer kumar  Nizams Institute of Medical Sciences   Department of Anesthesiology, speciality block operation room .
Hyderabad
TELANGANA 		 9705553608

sudheerkeerthi98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMS Institutional Ethics Committte  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N202||Calculus of kidney with calculus of ureter,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Perioperative administration of normal saline ( 2ml )  In comparator group, 2ml of normal saline preoperatively and observing for post operative pain scores and analgesia requirement 
Intervention  Preoperative administration of single dose (8mg) systemic dexamethasone  Preoperative administration of single dose (8mg) systemic dexamethasone and observing for post operative pain scores and analgesia requirement 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Male 
Details  patients undergoing elective percutaneous nephrolithotomy under general anesthesia with ASA grade 1 and 2 
 
ExclusionCriteria 
Details  patient refusal , chronic steroid use, diabetes mellitus patients, bilateral surgery 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Effect of single-dose [8mg iv] systemic preoperative administration of dexamethasone on postoperative analgesic requirement in patients undergoing percutaneous nephrolithotomy  VAS score is assessed at immediate postoperative period, 6hrs, 12 hrs, 24 hrs, 48 hrs postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
To see the effect of dexamethasone on the blood sugar levels  Blood sugars will be measured after one hour of starting and at the end of the surgery 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   25/04/2025 
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 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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  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) - 

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    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  
Despite advances in pain management, many surgical patients still experience moderate to severe pain, affecting 20-40% of those undergoing complex procedures such as spinal, abdominal, and orthopaedic surgeries. This pain can lead to delayed recovery, increased morbidity, and the risk of chronic pain. Multimodal analgesia is preferred for acute pain, but opioids remain the primary treatment for severe pain, despite their potential for adverse effects and addiction
                              Percutaneous nephrolithotomy (PCNL), the standard treatment for large renal calculi, offers less invasiveness and quicker recovery compared to open surgery. However, significant postoperative pain from nephrostomy tubes, which are inserted for drainage and access, can lead to prolonged hospital stays and patient dissatisfaction. Pain stems from visceral and somatic sources related to the surgical site and tube placement
                              Glucocorticoids, known for their anti-inflammatory and immunomodulatory effects, have shown promise in reducing postoperative pain in other contexts. Dexamethasone, in particular, has been studied for its potential analgesic benefits when given as a single preoperative dose. However, results have been inconsistent, and concerns about long-term side effects of glucocorticoids persist
                              Further research is needed to determine their efficacy and safety in the context of postoperative pain management. In this study we are evaluating the effect of intravenous dexamethasone on postoperative analgesia in patients undergoing percutaneous nephrolithotomy
 
Close