FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/07/055193 [Registered on: 13/07/2023] Trial Registered Prospectively
Last Modified On: 12/07/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Assessment of pain relief between two blocks - erector spinae block & paravertebral block in patients undergoing removal of kidney stones after surgery 
Scientific Title of Study   The Comparison of the efficacy between ultrasound guided paravertebral and erector spinae block for post operative analgesia in percutaneous nephrolithotomy surgeries using Levobupivacaine, a prospective, randomised comparative study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Karthik G S 
Designation  Proffesor 
Affiliation  RajaRajeswari medical college and hospital 
Address  Department of Anaesthesiology Rajarajeshwari medical college and hospital . Kambipura, Mysore road, Bangalore

Bangalore
KARNATAKA
560074
India 
Phone  9538220515  
Fax    
Email  drgskarthik@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Karthik G S 
Designation  Proffesor 
Affiliation  RajaRajeswari medical college and hospital 
Address  Department of Anaesthesiology Rajarajeshwari medical college and hospital . Kambipura, Mysore road, Bangalore


KARNATAKA
560074
India 
Phone  9538220515  
Fax    
Email  drgskarthik@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ashwani Kristipati 
Designation  junior resident  
Affiliation  RajaRajeswari medical college and hospital 
Address  Department of Anaesthesiology Rajarajeshwari medical college and hospital . Kambipura, Mysore road, Bangalore

Bangalore
KARNATAKA
560074
India 
Phone  9550250605  
Fax    
Email  ashwanikristipati@gmail.com  
 
Source of Monetary or Material Support  
Rajarajeshwari medical college and hospital, Kambipura, Mysore road, Bangalore, Karnataka 
 
Primary Sponsor  
Name  Rajarajeshwari medical college and hospital 
Address  Kambipura, Mysore road, Bangalore, Karnataka, 560074 
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 Karthik G S  Rajarajeshwari medical college and hospital  Department of Anaesthesiology, Rajarajeshwari medical college and hospital, Kambipura, Mysore Road, Bangalore
Bangalore
KARNATAKA 
9538220515

drgskarthik@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE, RAJARAJESHWARI MEDICAL COLLEGE AND HOSPITAL  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Erector spinae block  ESPB will be performed in group E before extubation using the portable ultrasound device with a linear 6–13 MHz ultrasound transducer wrapped in a sterile cover. At the end of surgery, under strict aseptic conditions, counting down from C7, T8 vertebra will be identified under ultrasound guidance using curvilinear probe. Probe will be moved until Erector spinae muscle visualised and using out of plane technique using 23G Quincke Babcock needle will be directed towards transverse process underneath fascia of Erector spinae muscle. 2-3ml of normal saline will be injected to confirm the spread following which 20 ml of 0.25% Levobupivacaine will be injected 
Intervention  Inj Levobupivacaine 0.25% in Erector spinae block and Paravertebral block  Inj Levobupivacaine 0.25% 20 ml will be injected in two separate groups to compare their efficacy postoperatively in the first 24 hours till the need of first analgesia. 1.Inj Levobupivacaine 0.25% 20 ml in erector spinae muscle 2. Inj Levobupivacaine 0.25% 20 ml in Paravertebral space between costo transverse ligament and pleura.  
Comparator Agent  Paravetrebral block  PVB will be performed in group E before extubation using the portable ultrasound device with a linear 6–13 MHz ultrasound transducer wrapped in a sterile cover. At the end of surgery, under strict aseptic conditions,transverse process at T8 level will be visualised and the study drug will be deposited in paravertebral space between the costo transverse ligament and pleura which will be visualised as hypoechoic layer. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA 1 and !! Patients aged between 20 and 60 years undergoing Percutaneous nephrolithotomy surgeries 
 
ExclusionCriteria 
Details  Patient refusal
Patients with known hypersensitivity to local anaesthetics
Patients with bleeding disorder, uncontrolled diabetesmellitus, renal and liver diseases.
pregnant women
patients with epilepsy.
mentally unstable patients 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare & assess the analgesic efficacy postoperatively between Erector spinae block & paravetrebral block  To compare & assess the analgesic efficacy postoperatively between Erector spinae block & paravetrebral block in first 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the need of rescue analgesia postoperatively between Erector spinae block & paravertebral block.
Comparison of hemodynamic parameters.
complications if any 
Postoperative period for first 24 hours 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 4 
Date of First Enrollment (India)   21/07/2023 
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="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Percutaneous nephrolithotomy (PCNL) is a minimally invasive surgical

technique for treating complicated large renal stones. It is commonly

accompanied by intense post operative pain and discomfort. Multiple methods

like non-steroidal anti-inflammatory drugs, opioids(tramadol, morphine and

fentanyl), neuraxial block(epidural analgesia) and different regional anesthesia techniques(intercostal nerve block, para-vertebral block) have been described in

the literature for post operative pain management with variable outcomes.

Erector spinae plane (ESP) block is an interfascial blockade and consists of an injection of the local anesthetic in a fascial plane placed between erector spinae muscles and the tip of the transverse vertebral process . The anesthetic spreads over the fascial plane both in the cranial and caudal direction, also diffusing anteriorly and laterally at several levels by one dermatome per 3.4 mL of injected liquid.

Thoracic paravertebral block (TPVB) is the technique of injecting local anesthetic adjacent to the thoracic vertebra close to where the spinal nerves emerge from the intervertebral foramina. This results in ipsilateral somatic and sympathetic nerve blockade in multiple contiguous thoracic dermatomes above and below the site of injection. It is effective in treating acute 10and chronic pain of unilateral origin from the chest and abdomen. 

Aim is to compare the Duration of Analgesia between EPSB and TPVB In Percutaneous Nephrolithotomy Surgeries Using Levobupivacaine 0.25% from administration of block till the requirement of first analgesia. 


Method of collection of data.

After obtaining institutional ethical committee clearance, a comparative study will be carried in Rajarajeshwari Medical college and Hospital in Department of Anaesthesia. 

The purpose, the procedure and the risks involved with the study will be explained to the patient and an informed consent will be taken . 

50 patients of ASA 1 and ASA 2 aged between 20 and 60 years scheduled for elective PCNL surgeries will be selected based on inclusion or exclusion criteria as mentioned above. All patients will be subjected to detailed preanesthetic evaluation. Routine and specific investigations will be done as per patients clinical evaluation along with optimising with regular medication if required. Patients will be randomly allocated into two groups of 25 each by single blinded open envelope technique as follows : 

Under ultrasound guidance using, curvilinear probe 

Group E – Patients will receive 25 ml of 0.25% Levobupivacaine at T8 level (erector spinae block) 

Group PV – Patients will receive 25 ml of 0.25% Levobupivacaine at T8 level.(paravertebral block) 


All the patients will be reviewed and explained about the procedure. 

Patients will be kept nil by oral for 6 hours and will be given T.Pantoprazole 40mg T. Alpralozolam. 

On arrival of the patient to the operation theatre, monitors will be connected and base line respiratory rate, pulse rate, non-invasive blood pressure, SPO2 and ECG recorded. Intravenous line of 18G shall be secured and intravenous fluids will be started as per requirement. 

Patient in supine position with adequate preoxygenation and premedication with Inj Midazolam 0.01mg/kg and Inj Glycopyrolate 0.2mg will be induced with Inj Fentanyl 1-2mcg/kg, Inj Propofol 2mg/kg and Inj. Vecuronium 0.1mg/kg. 

After obtaining adequate muscle relaxation, laryngoscopy will be done and intubated with endotracheal tube. Bilateral airway entry is confirmed and secured appropriately. 

Patient is changed to prone position and hemodynamic parameters will be monitored throughout the procedure at regular intervals. 

At the end of surgery, under strict aseptic conditions, counting down from C7, T8 vertebra will be identified under ultrasound guidance using curvilinear probe. 

Probe will be moved until Erector spinae muscle visualised and using out of plane technique using 23G Quincke Babcock needle will be directed towards transverse process underneath fascia of Erector spinae muscle. 2-3ml of normal saline will be injected to confirm the spread following which 20 ml of 0.25% Levobupivacaine will be injected. 

Similarly in the other group, transverse process at T8 level will be visualised and the study drug will be deposited in paravertebral space between the costo transverse ligament and pleura which will be visualised as hypoechoic layer. 

The patient is changed to supine position and extubation will be done after a reversal of residual neuromuscular block with neostigmine (0.05 mg/kg) and glycopyrrolate (0.01 mg/kg) at the end of the surgery. Patients will be transferred to post anesthesia care unit to monitor hemodynamic parameters, postoperative pain, sedation, nausea and vomiting at 0,1,2,4,6,8,12,16,20,24hrs. Patients will be evaluated pain postoperatively for the duration of analgesia and pain will be assessed using a standard 10 cm linear VAS. 

Pain assessment will be done 20 minutes after extubation which will be considered as zero time. 

Total duration of analgesia will be taken from zero time till the first rescue analgesic requirement. 

When VAS score is more than or equal to 4, Inj.Paracetamol 1g will be given as rescue analgesia. Total number of doses of Inj Paracetamol 1g given in 24 hours will be noted. 

Patients will be left out of the study in case of block failures 

 
Close