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CTRI Number  CTRI/2022/10/046348 [Registered on: 11/10/2022] Trial Registered Prospectively
Last Modified On: 06/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Does pain killer at erector spinae plane effective in relieving post op pain after kidney stone removal Surgery?  
Scientific Title of Study   Efficacy of ultrasound Guided Erector Spinae Plane Block in Percutaneous Nephrolithotomy (PCNL)Surgery. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  dr Satya Prakash Pandey 
Designation  Junior Resident 
Affiliation  Uttar Pradesh University of Medical Sciences, Saifai,Etawah 
Address  Department of Anesthesiology, UPUMS, Saifai
UPUMS, Saifai
Etawah
UTTAR PRADESH
206130
India 
Phone  8266882902  
Fax    
Email  satyapriyasnmc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR URVASHI YADAV 
Designation  professor 
Affiliation  Uttar Pradesh University of Medical Sciences, Saifai,Etawah 
Address  Department of Anesthesiology, UPUMS, Saifai
UPUMS, Saifai
Etawah
UTTAR PRADESH
206130
India 
Phone  07500186161  
Fax    
Email  drurvikgmu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  dr Satya Prakash Pandey 
Designation  Junior Resident 
Affiliation  Uttar Pradesh University of Medical Sciences, Saifai,Etawah 
Address  Department of Anesthesiology, UPUMS, Saifai
UPUMS, Saifai
Etawah
UTTAR PRADESH
206130
India 
Phone  8266882902  
Fax    
Email  satyapriyasnmc@gmail.com  
 
Source of Monetary or Material Support  
Uttar Pradesh University of Medical Sciences, Saifai 
 
Primary Sponsor  
Name  UPUMS, Saifai 
Address  Department of Anaesthesiology, UPUMS, Saifai, Etawah 
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 Satya Prakash Pandey  UPUMS, SAIFAI  Department of Anaesthsia, UPUMS Saifai
Etawah
UTTAR PRADESH 
8266882902

satyapriyasnmc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ethical committee of University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Erector Spinae Plane BLOCK with Local Anaesthetic  After completion of surgery group E will receive Erector Spinae Plane Block with Local Anaesthetic (LA) mixture 10 ml of 0.5% Bupivacaine, 5 ml of Lignocaine 2%, 1 ml (50mcg) of fentanyl, 4 ml of NS to make a mixture of 20 ml, which will be injected on the side of surgery under ultrasound guidance. It will take 5 to 10 min to locate and injust the study drug. 
Comparator Agent  Erector Spinae Plane Block with Normal Saline  After completion of surgery Group C will receive Erector Spinae Plane Block with 20 ml of normal saline injected on the side of surgery under ultrasound guidance. The procedure will take 5 to 10 min approximately. 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  . ASA I and II
2. Patients between the age of 35-65 years
3. Patients with body mass index between 18-30 kg/m2 [BMI 18-30 kg/m2]
4. Pt. posted for elective PCNL surgery.
5. Duration of surgery between 90-120 minutes.
 
 
ExclusionCriteria 
Details  . Patients refusal.
2. Neuro Psychiatric Disorder or on Chronic use of Psychoactive medications.
3. Hepatic impairment.
4. History of Epilepsy.
6. Pregnant and lactating females.
7. History of alcohol and drug abuse.
8. Coagulation abnormality.
9 Allergy to any study drug.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Post operative Pain by VAS Scores   30 min, 2h, 6h,12h and 24h postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
Total Rescue Analgesic Required   in 24 h 
Satisfaction level  12 h after surgery 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/10/2022 
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
Modification(s)  
published in Cureus journal of medical sciences 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

A sealed envelope randomization will be employed to allocate patients  into two groups  either  to  receive  ESP  block with local anaesthetic drug  bupivacaine and patient receiving ESP block with normal saline.

Patient will be premedicated with intravenous inj. glycopyrrolate (5mcg/kg), inj. Midazolam (0.05mg/kg), inj. Fentanyl (2mcg/kg). Induction will be achieved by inj.  Propofol (2mg/kg) and intubation will be facilitated with inj. vecuronium (0.08mg/kg). Anaesthesia will be maintained with 50% of nitrous oxide in oxygen and isoflurane along with inj. vecuronium(0.02mg/kg) maintenance dose as required.  All hemodynamics parameter will be recorded at every 15 min interval until patient will be shifted from the operating room.

Erector spinae plane  block  will  be performed  after completion of pcnl surgery  under  ultrasound  guidance  using  a  linear  transducer.

  Group E (n=30):  group E will receive  Erector  Spinae  Plane Block with  Local Anaesthetic (LA) mixture  10 ml  of 0.5% Bupivacaine, 5 ml of  Lignocaine 2%, 1 ml (50mcg) of fentanyl, 4 ml of  NS  to  make  a  mixture  of  20 ml,  which  will be  injected on the side of surgery.

Group C (n=30):  group C will receive Erector  Spinae  Plane Block  with 20 ml of   normal saline   injected  on the side of surgery.

In Group E patients, Erector  Spinae  Plane (ESP) block  will  be  performed  in  prone position  after  ensuring  skin  asepsis, we  place  high  frequency [5-13 MHz]  linear  ultrasound  transducer  in  sterile  sheath  3 cm lateral  to  the  T9  spinous   process to visualize  the  back  muscles: trapezius  above, rhomboid  major  in  the  middle, and erector spinae  muscle  on  the  bottom. A 23G 10-cm  Touhy  needle  will  be  inserted  using  an  in plane  superior to inferior approach  until the needle touched the Transverse Process  crossing all three muscles. A volume  of  20 ml  of  LA  mixture  will  be  injected.

 In Group C  patients, same procedure as above will be performed, but in place of drug we will inject a volume of 20 ml of  normal saline on the surgery side.  

After completion of ESP block procedure, all  the anaesthetic agent will be stopped and after the onset of spontaneous respiration, residual neuromuscular blockade will be reversed with Inj. Neostigmine (5mcg/kg) and Inj. Glycopyrrolate (10 mcg/kg)  and  extubation will  be  done . before shifting the pts to postoperative ward we will give injection paracetamol 15mg/kg body wt as analgesic to all pts.

PTs will be assessed for pain by VAS scores (ranging from 0 indicating no pain to 10 indicate extreme pain) will be recorded 30 min and 2,4,6,12,and 24 hr. postoperatively.

  When VAS Score is more then 4 we will give intravenous tramadol 100 mg (maximum up to 400 mg) as postoperative rescue analgesic. . The  amount  of  rescue  analgesia  require  in  both  groups during  first  24 h  after operation , pts satisfaction score using Likert Verbal Rating  Scale and complications if any occur  will  be  recorded.

The  hemodynamic  parameters  like  Heart rate, Systolic Blood pressure, Diastolic blood pressure , Mean arterial pressure, Saturation(spo2), Etco2 will  be  taken  after  the  block and  patients  will  be  monitered  upto  24  hrs  after  the  block.  Adverse  events  such  as  Bradycardia (HR <50 bpm  or  20%  decrease  from  the baseline  value), Hypotension (fall  in  blood  pressure  by  20%  from  the  baseline or an  absolute  MAP <60 mmHg) , Nausea,  Vomiting,  Dryness  of  mouth  or  any  other  events  during  or  within   the  procedure  will  be  noted. Bradycardia  will  be treated  with  increment  doses  of  injection  Atropine 0.3mg  and  Hypotension  will be  managed  with  a  bolus  of  IV  crystalloids  or  with  increments  of  injection Mephentermine  6 mg.

 
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