Role of lidocaine containing irrigation fluid in prevention of post-operative catheter related bladder discomfort among patient undergoing bladder surgery.
- Conditions
- Malignant neoplasm of bladder, unspecified,
- Registration Number
- CTRI/2020/10/028352
- Lead Sponsor
- PGIMER Chandigarh
- Brief Summary
After careful pre anaesthetic check-up and routineinvestigations, an informed consent will be taken from the patients. Patientswill be kept fasting for more than 8 hours for solid food and 2 hours for clearfluid.
In the operation theatre, the standard monitors[electrocardiograph (ECG), pulse oximeter (SpO2), non-invasive bloodpressure (NIBP) end tidal carbon dioxide (EtCO2)] will be attachedand baseline heart rate (HR) and blood pressure (systolic, diastolic and mean)will be noted.
General anesthesia will be induced usingpropofol (2 mg/kg), fentanyl (2mg/kg) and atracurium followed by insertion of anappropriate size Proseal laryngeal mask airway (PLMA). Anesthesia will be maintained withsevoflurane (2–3 vol%) in a mixture of N2O 50% and oxygen 50%; the end-tidalconcentration of sevoflurane will be adjusted to maintain a target MAC of 1 andappropriate vital signs. Normal saline will be infused continuously through outthe surgery to irrigate the bladder in-group N where as in group L normalsaline with a lidocaine dose of 0.01% (100mg in 1L NS) will be used forirrigation 30 minutes before completion of surgery. After tumor resection urinarybladder catheterization will be done using a ≥20 Fr catheter, and the balloonwill be inflated with 10 mL of distilled water. A 2% lidocaine gel will be usedto lubricate the catheter, which will be fixed in the suprapubic area withadhesive tape. Appropriate antiemetic medication and paracetamol 15mg/kg willbe given in end of surgery. After conforming that the patient is fullyconscious and maintain adequate spontaneous ventilation the LMA will be removedand the patients will be shifted to the PACU.
Severity of CRBD symptoms will be graded asfollowing; none (patients did not complain of CRBD when questioned);mild (reported by patients only when asked); moderate (reported by patientsindependently, i.e., without being asked, and not accompanied by any behavioralresponse); or severe (reported by patients independently along with behavioralresponses such as flailing limbs, strong vocal response, and attempts to pullout the catheter).
An assessment of CRBD willbe done on receiving the patient in PACU immediately (0 hour), and at 1,2and 6hour post surgery. Tramadol (1mg/kg)will be given if patient complains ofmoderate to severe degree of CRBD. Patientpain will also be evaluated for pain along with assessment of CRBD using NRS scalein which 0 = no pain and 10 = worst pain imaginable. For rescue analgesia abolus of fentanyl 1mg/kg will be given, if patient NRS scale is >4. Patientsatisfaction will be assessed at 0, 1,2 and 6 hours post-surgery by GLOBALPERCEIVED EFFECTS on a 7-point scale (GPES) .
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 94
1.Patient in the age group of 20-75 years planned for elective TURBT surgery under general anaesthesia 2.ASA I-II.
1.Allergy to lidocaine 2.Known case of arrhythmias, heart block, AF 3.Case of liver cirrhosis 4.Severe heart disease, respiratory disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 1.Incidence of CRBD at 1,2,6 hours after surgery 2.Post operative pain and use of rescue medication (fentanyl, tramadol)
Trial Locations
- Locations (1)
Main OT Complex, Nehru Hospital, PGIMER, Chandigarh
🇮🇳Chandigarh, CHANDIGARH, India
Main OT Complex, Nehru Hospital, PGIMER, Chandigarh🇮🇳Chandigarh, CHANDIGARH, IndiaAjay SinghPrincipal investigator9999276845ajay.ydv2509@gmail.com