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CTRI Number  CTRI/2020/10/028352 [Registered on: 12/10/2020] Trial Registered Prospectively
Last Modified On: 17/02/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Role of lidocaine containing irrigation fluid in prevention of post-operative catheter related bladder discomfort among patient undergoing bladder surgery. 
Scientific Title of Study   Role of lidocaine containing irrigation fluid in prevention of post-operative catheter related bladder discomfort among patient undergoing transurethral resection of bladder tumors: A randomized, double blind, controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ajay Singh 
Designation  Assistant Professor 
Affiliation  PGIMER Chandigarh 
Address  Nehru Hospital, PGIMER,Sector 12, Chandigarh 160012
CHANDIGARH
Chandigarh
CHANDIGARH
160012
India 
Phone  9999276845  
Fax  01722756500  
Email  ajay.ydv2509@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ajay Singh 
Designation  Assistant Professor 
Affiliation  PGIMER Chandigarh 
Address  Nehru Hospital, PGIMER,Sector 12, Chandigarh 160012
CHANDIGARH

CHANDIGARH
160012
India 
Phone  9999276845  
Fax  01722756500  
Email  ajay.ydv2509@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ajay Singh 
Designation  Assistant Professor 
Affiliation  PGIMER Chandigarh 
Address  Nehru Hospital, PGIMER,Sector 12, Chandigarh 160012
CHANDIGARH

CHANDIGARH
160012
India 
Phone  9999276845  
Fax  01722756500  
Email  ajay.ydv2509@gmail.com  
 
Source of Monetary or Material Support  
PGIMER, CHANDIGARH, INDIA 
 
Primary Sponsor  
Name  PGIMER Chandigarh 
Address  Nehru Hospital, PGIMER Sector 12, Chandigarh 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 
Ajay Singh  Main OT Complex, Nehru Hospital, PGIMER, Chandigarh  Nehru Hospital, PGIMER,Sector 12, Chandigarh 160012 CHANDIGARH
Chandigarh
CHANDIGARH 
9999276845
01722756500
ajay.ydv2509@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C679||Malignant neoplasm of bladder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  •Group L- normal saline with lidocaine 0.01% (100mg in 1 L NS) irrigation fluid  Normal saline will be infused continuously through out the surgery to irrigate the bladder in-group N where as in group L normal saline with a lidocaine dose of 0.01% (100mg in 1L NS) will be used for irrigation 30 minutes before completion of surgery 
Comparator Agent  Group N- only normal saline irrigation fluid and 20 ml NS will be added as placebo in last 1 L of irrigation fluid  Normal saline will be infused continuously through out the surgery to irrigate the bladder in-group N and 20 ml NS will be added to 1L irrigation fluid. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Patient in the age group of 20-75 years planned for elective TURBT surgery under general anaesthesia
2.ASA I-II
 
 
ExclusionCriteria 
Details  1. Allergy to lidocaine
2. Known case of arrhythmias, heart block, AF
3. Case of liver cirrhosis
4. Severe heart disease, respiratory disease
 
 
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 
Incidence of moderate to severe Catheter Related Bladder Discomfort (CRBD) in two group immediately after surgery.   Incidence of moderate to severe CRBD in two group immediately after surgery.  
 
Secondary Outcome  
Outcome  TimePoints 
1.Incidence of CRBD at 1,2,6 hours after surgery
2.Post operative pain and use of rescue medication (fentanyl, tramadol)
3.Side effect of lidocaine and rescue medicaton.
4.Patient satisfaction.
Surgical comlication (bleeding,)
 
Induction of anaesthesia to 24 hours after surgery 
 
Target Sample Size   Total Sample Size="94"
Sample Size from India="94" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/10/2020 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

After careful pre anaesthetic check-up and routine investigations, an informed consent will be taken from the patients. Patients will be kept fasting for more than 8 hours for solid food and 2 hours for clear fluid.

In the operation theatre, the standard monitors [electrocardiograph (ECG), pulse oximeter (SpO2), non-invasive blood pressure (NIBP) end tidal carbon dioxide (EtCO2)] will be attached and baseline heart rate (HR) and blood pressure (systolic, diastolic and mean) will be noted.

General anesthesia will be induced using propofol (2 mg/kg), fentanyl (2mg/kg) and atracurium followed by insertion of an appropriate size Proseal laryngeal mask airway  (PLMA). Anesthesia will be maintained with sevoflurane (2–3 vol%) in a mixture of N2O 50% and oxygen 50%; the end-tidal concentration of sevoflurane will be adjusted to maintain a target MAC of 1 and appropriate vital signs. Normal saline will be infused continuously through out the surgery to irrigate the bladder in-group N where as in group L normal saline with a lidocaine dose of 0.01% (100mg in 1L NS) will be used for irrigation 30 minutes before completion of surgery. After tumor resection urinary bladder catheterization will be done using a ≥20 Fr catheter, and the balloon will be inflated with 10 mL of distilled water. A 2% lidocaine gel will be used to lubricate the catheter, which will be fixed in the suprapubic area with adhesive tape. Appropriate antiemetic medication and paracetamol 15mg/kg will be given in end of surgery. After conforming that the patient is fully conscious and maintain adequate spontaneous ventilation the LMA will be removed and the patients will be shifted to the PACU.

Severity of CRBD symptoms will be graded as following; none (patients did not complain of CRBD when questioned); mild (reported by patients only when asked); moderate (reported by patients independently, i.e., without being asked, and not accompanied by any behavioral response); or severe (reported by patients independently along with behavioral responses such as flailing limbs, strong vocal response, and attempts to pull out the catheter).  

An assessment of CRBD will be done on receiving the patient in PACU immediately (0 hour), and at 1,2and 6 hour post surgery. Tramadol (1mg/kg)will be given if patient complains of moderate to severe degree of CRBD. Patient pain will also be evaluated for pain along with assessment of CRBD using NRS scale in which 0 = no pain and 10 = worst pain imaginable. For rescue analgesia a bolus of fentanyl 1mg/kg will be given, if patient NRS scale is >4. Patient satisfaction will be assessed at 0, 1,2 and 6 hours post-surgery by GLOBAL PERCEIVED EFFECTS on a 7-point scale (GPES) . 
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