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CTRI Number  CTRI/2023/09/058151 [Registered on: 29/09/2023] Trial Registered Prospectively
Last Modified On: 13/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Relief in post operative catheter related bladder discomfort after using lidocaine or dexmedetomidine in irrigation fluid in patients undergoing percutaneous nephrolithotomy (PCNL) or ureteroscopic lithotripsy(URSL): A double blinded randomized controlled trial  
Scientific Title of Study   Role of lidocaine and dexmedetomidine containing irrigation fluid in prevention of post operative catheter related bladder discomfort in patients undergoing percutaneous nephrolithotomy and ureteroscopic lithotripsy: A double blinded randomized controlled 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  Sahil Sachdeva  
Designation  Senior Resident MCh Urology 
Affiliation  PGIMER CHANDIGARH 
Address  Advanced Urology Centre (26) First Floor, Level 2 Nehru Hospital, Post graduate institute of medical education and research(PGIMER) CHANDIGARH,160012

Chandigarh
CHANDIGARH
160012
India 
Phone  7019821130  
Fax    
Email  sssahilsachdeva12@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Girdhar Singh bora 
Designation  Additional Professor, Urology  
Affiliation  PGIMER CHANDIGARH 
Address  Advanced Urology Centre (26) First Floor, Level 2 Nehru Hospital, Post graduate institute of medical education and research Chandigarh,160012

Chandigarh
CHANDIGARH
160012
India 
Phone  7087008968  
Fax    
Email  girdhar2k@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sahil Sachdeva  
Designation  Senior resident MCh Urology 
Affiliation  PGIMER CHANDIGARH 
Address  Advanced Urology Centre (26) First Floor, Level 2 Nehru Hospital, Post graduate institute of medical education and research (PGIMER) Chandigarh,160012

Chandigarh
CHANDIGARH
160012
India 
Phone  7019821130  
Fax    
Email  sssahilsachdeva12@gmail.com  
 
Source of Monetary or Material Support  
Urology department (AUC-26) Level II , First Floor, Nehru Hospital Post graduate institute of medical education and research Chandigarh, Sector-12 160012 
 
Primary Sponsor  
Name  Post graduate institute of medical education and research Chandigarh  
Address  Madhya Marg Nehru Hospital Level II , First Floor Post Graduate Institute of Medical Education and Research Chandigarh, Sector 12 160012  
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 
Dr Sahil Sachdeva  Nehru Hospital (Post Graduate Institute of Medical Education and Research)  Advanced Urology Centre (26), Urology Office , LEVEL II, Nehru Hospital, Post Graduate Institute of Medical Education and Research,Madhya Marg, CHANDIGARH,160012
Chandigarh
CHANDIGARH 		 7019821130

sssahilsachdeva12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Postgraduate Institute of Medical Education and Research, Chandigarh Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Drug name- lidocaine or dexmedetomidine or plain Normal saline in irrigation solution 1L NS (intravesical route)   Route of administration - Intravesical . Frequency of drug given- Once Procedure- PCNL and/or URSL to see reduction in the incidence of moderate to severe Catheter related bladder discomfort. 1L Normal saline will be infused to irrigate the bladder in Group N whereas in Group L normal saline with a lidocaine dose of 0.01% (100mg in 1L NS) (dose of drug) will be used for irrigation intravesically). During the procedure, urinary bladder catheterization will be done using a 16 Fr triway catheter, and the balloon will be inflated with 10 mL of distilled water and with 10 minutes holding of 150 ml irrigation fluid and remaining 850 ml continuous irrigation with NS/irrigation fluid with dexmedetomidine (group D) 0.5μg/kg ( micrograms/kg) or lignocaine (group L) from end of the procedure to 30 mins(duration of intervention )in post op recovery period will be given at the rate of 30-40 ml / minute. A nephrostomy tube will additionally be placed in case of PCNL if needed.  
Comparator Agent  Use of 0.0l% lidocaine or 0.5μg/kg dexmedetomidine in 1L irrigation solution (dose of drug) compared to normal saline irrigation 1L through intravesical route for 30 minutes in patient undergoing PCNL and/or URSL to see reduction in the incidence of moderate to severe Catheter related bladder discomfort.  Group L: normal saline with lidocaine 0.01% (100mg in 1 L NS) irrigation Group D: normal saline with dexmedetomidine (0.5 μg/kg{micrograms/kg}in 1 L NS) irrigation Group N: only normal saline irrigation 1 Litre 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  Age group- 20-60years
Male patients
ASA status- I or II
Patients scheduled for elective PCNL/URSL surgery 
 
ExclusionCriteria 
Details  Allergy to lidocaine.

Known case of arrhythmias, heart block, atrial fibrillation.

Case of liver cirrhosis.

Severe heart disease, respiratory disease.

Patient previously on catheter, stent , previous urethral instrumentation. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence of CRBD(catheter related bladder symptoms) in the three groups ( lidocaine vs dexmedetomidine containing irrigation fluid intravesical vs normal saline) in patients undergoing percutaneous nephrolithotomy & ureteroscopic immediately after surgery at 0,1,2,6 hrs  0,1,2,6 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcomes will be to compare incidence of bladder, suprapubic or urethral pain at 0,1,2,6 hours after surgery,
Use of rescue medications (ketorolac, tramadol),
study side effect of lidocaine & rescue medications,
Side effects of dexmedetomidine,
Patient satisfaction.
surgical complications at 0,1,2,6hrs 		 0,1,2,6hrs 
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
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)   01/10/2023 
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   This study is a randomised , double blind , parallel group , single-centre trial to study the role of lidocaine and dexmedetomidine containing irrigation fluid in prevention of post operative catheter related bladder discomfort in patients undergoing percutaneous nephrolithotomy and ureteroscopic lithotripsy. The primary outcome measures will be to compare the incidence of CRBD (catheter related bladder discomfort) in the three groups immediately after surgery at 0,1,2,6 h in males of 20-60yrs undergoing elective surgery. The secondary outcomes will be to compare incidence of bladder, suprapubic or urethral pain at 0,1,2,6 hours after surgery , use of rescue medications (ketorolac, tramadol) , identification of side effects of lidocaine/dexmedetomidine and rescue medications , patient satisfaction using global perceived effects on a 7- pointer scale (GPES)  and surgical complications.

 
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