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CTRI Number  CTRI/2023/10/059107 [Registered on: 25/10/2023] Trial Registered Prospectively
Last Modified On: 22/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Compare the mode of anaesthesia between Geneal and spinal anaesthesia for percutaneous nephrolithotomy surgeries. 
Scientific Title of Study   Comparison between general anesthesia and spinal anaesthesia for percutaneous nephrolithotomy surgeries: A randomised comparative 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  Dr Bharat Kumar 
Designation  PG Student 
Affiliation  Dr.SN Medical college,Jodhpur,Rajasthan 
Address  Department of anaesthesiology,MDM Hospital,Dr.SN Medical college,Jodhpur
Department of anaesthesiology,MDM Hospital,Dr.SN Medical college,Jodhpur
Jodhpur
RAJASTHAN
342003
India 
Phone  9529134098  
Fax    
Email  bharatpatel957130240@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Geeta Singariya 
Designation  Senior Professor 
Affiliation  Dr.SN Medical college,Jodhpur,Rajasthan 
Address  Department of anaesthesiology,MDM Hospital,Dr.SN Medical college,Jodhpur
Department of anaesthesiology,MDM Hospital,Dr.SN Medical college,Jodhpur
Jodhpur
RAJASTHAN
342003
India 
Phone  94144803554  
Fax    
Email  geetamanojkamal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Geeta Singariya 
Designation  Senior Professor 
Affiliation  Dr.SN Medical college,Jodhpur,Rajasthan 
Address  Department of anaesthesiology,MDM Hospital,Dr.SN Medical college,Jodhpur
Department of anaesthesiology,MDM Hospital,Dr.SN Medical college,Jodhpur
Jodhpur
RAJASTHAN
342003
India 
Phone  9414803554  
Fax    
Email  geetamanojkamal@gamil.com  
 
Source of Monetary or Material Support  
Dr. SN Medical college Jodhpur,Rasthan 
 
Primary Sponsor  
Name  Dr. SN Medical college,Jodhpur,Rajasthan 
Address  Residency Rd., sector-D shastri,nagar Jodhpur,Rajasthan 
Type of Sponsor  Government 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 Bharat Kumar  Dr. SN Medical college,Jodhpur Rajasthsn  Department of anaesthesiology,MDM Hospital,Dr.SN Medical college,Jodhpur
Jodhpur
RAJASTHAN 		 9529134098

bharatpatel957130240@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DR SNMC INSTITUTIONALETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N200||Calculus of kidney, (2) ICD-10 Condition: N200||Calculus of kidney, (3) ICD-10 Condition: N202||Calculus of kidney with calculus of ureter,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Opioid consumption for postoperative analgesia after 24 hrs of Surgeries  Comparison between General anaesthesia and Spinal anaesthesia for percutaneous nephrolithotomy surgeries. A randomized comparative trial. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All the patients belonging to American Society of anaesthesiologists (ASA) grade- I & II, age between 18 to 60 years of either gender with BMI < 24.9 posted for elective PCNL surgery will be included in this study. 
 
ExclusionCriteria 
Details  · Patient refusal.
· Patients with local skin infections at site of injection.
· Patients with history of allergy to any anaesthetic drugs
· Horseshoe or ectopic kidney as diagnosed in USG
· Patients with spine deformity as confirm in X-ray
· Patients with coagulation disorders like in DIC (abnormal PT/INR, platelet count)
· Pregnancy which is confirmed with card test
· Substance abusers (like opium or other addiction)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Typically focuses on the effectiveness of the anaesthesia method in terms of pain control within 24hrs after percutaneous nephrolithotomy surgery.  compare the total opioid consumption during postoperative 24 hours after general anesthesia and spinal anesthesia in patients undergoing percutaneous nephrolithotomy surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the duration of analgesia (time for request of first rescue analgesia after surgery)
2. To compare the perioperative complication
3. Hemoglobin and haematocrit will be measured 24 hours after the surgery and will be compared with the preoperative values
4. To compare patient’s and surgeon’s satisfaction by Likert’s scale
 		 24hrs after surgery 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   30/10/2023 
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 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 - NO
Brief Summary  



Spinal anaesthesia  has  better postoperative analgesia ( in terms of recruitment of analgesic) compared to general anaesthesia in patients undergoing percutaneous nephrolithotomy surgery.  
 
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