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
|
|
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
|
|
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) . |