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CTRI Number  CTRI/2022/08/045033 [Registered on: 29/08/2022] Trial Registered Prospectively
Last Modified On: 26/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Erector spinae plane block (block given in the back) for pain relief following kidney stone surgery 
Scientific Title of Study   Erector spinae plane block for postoperative analgesia following percutaneous nephrolithotomy: A randomized controlled 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 S Sonika 
Designation  PG Resident 
Affiliation  M S Ramaiah Medical College 
Address  Department of Anaesthesiology M S Ramaiah Medical College Bangalore
Department of Anaesthesiology M S Ramaiah Medical College Bangalore
Bangalore
KARNATAKA
560054
India 
Phone  9483392030  
Fax    
Email  sonika.shivakumar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tejesh C A 
Designation  Professor 
Affiliation  M S Ramaiah Medical College 
Address  Department of Anaesthesiology M S Ramaiah Medical College Bangalore
Department of Anaesthesiology M S Ramaiah Medical College Bangalore
Bangalore
KARNATAKA
560054
India 
Phone  9886481848  
Fax    
Email  drtejeshca@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Tejesh C A 
Designation  Professor 
Affiliation  M S Ramaiah Medical College 
Address  Department of Anaesthesiology M S Ramaiah Medical College Bangalore
Department of Anaesthesiology M S Ramaiah Medical College Bangalore

KARNATAKA
560054
India 
Phone  9886481848  
Fax    
Email  drtejeshca@yahoo.com  
 
Source of Monetary or Material Support  
M S Ramaiah Medical College Bangalore 
 
Primary Sponsor  
Name  M S Ramaiah Medical College 
Address  New BEL Road MSRIT Post MSR Nagar Bangalore 560054 
Type of Sponsor  Private medical college 
 
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 Tejesh C A  M S Ramaiah Medical College Hospital  Department of Anaesthesiology Second Floor M S Ramaiah Medical College Hospital New BEL Road Bangalore 560054
Bangalore
KARNATAKA 
9886481848

drtejeshca@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
M S Ramaiah Medical College Ethics Committee  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: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Erector spinae plane block with 0.25% Bupivacaine  Erector spinae plane block will be given under ultrasound guidance with 20mL of 0.25% Bupivacaine on the side of surgery only once after completion of the surgical procedure 
Comparator Agent  Erector spinae plane block with normal saline  Erector spinae plane block will be given under ultrasound guidance with 20mL of Normal saline on the side of surgery only once after completion of the surgical procedure 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  American Society of Anaesthesiology physical status 1 and 2
Unilateral Percutaneous Nephrolithotomy Surgery 
 
ExclusionCriteria 
Details  BMI ≥ 35kg/m2
Bilateral PCNL
Chronic analgesic use
Allergy to local anaesthetics
Contraindications to ESP block
Cognitive dysfunction
Pregnancy
Spine deformity
Relook Percutaneous Nephrolithotomy Surgery 
 
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 
Total analgesic requirement in the first 24 hours after surgery  Total analgesic dose consumed will be assessed at the end of 24 hours after surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
Time to first demand of rescue analgesia
 
Pain assessed at intervals of 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours after surgery 
Postoperative pain  Pain assessed at intervals of 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours after surgery 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
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   N/A 
Date of First Enrollment (India)   01/09/2022 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sonika.shivakumar@gmail.com].

  6. For how long will this data be available start date provided 22-04-2024 and end date provided 22-04-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Percutaneous nephrolithotomy (PCNL) is currently the frequently employed surgical procedure for the removal of large complex renal and proximal ureteric calculi. Being minimally invasive it has less morbidity, and allows early recovery and ambulation after surgery. Postoperative pain following PCNL has both visceral and somatic components. Visceral component arises from the kidney, renal capsule and ureter, while the somatic component from the skin incision and the nephrostomy tract. The nephrostomy tube that is inserted at the end of the procedure can elicit inflammatory reaction leading to pain and discomfort. 

Although PCNL is a minimally invasive procedure, postoperative pain can be severe and inadequate postoperative analgesia is a barrier to early recovery after surgery. Systemic analgesics like opioids, non-steroidal anti-inflammatory drugs (NSAIDs) and paracetamol form the mainstay for providing pain relief. However, opioids are associated with side effects like nausea, vomiting, pruritus, constipation, and respiratory depression, while NSAIDs may be relatively contraindicated in these patients who may have compromised renal function.

Regional anaesthetic techniques like intercostal nerve block, paravertebral block, epidural analgesia, peritubal infiltration and subcutaneous infiltration have been employed for providing postoperative analgesia following PCNL.Erector spinae plane [ESP] block is a recently described interfascial  plane block for providing postoperative analgesia following thoracic and abdominal surgeries.Its use for providing pain relief following PCNL is recently been described in literature,  However , there is paucity of literature providing its efficacy following PCNL surgery. Hence, the present study is designed to evaluate its role in providing postoperative analgesia following PCNL.

 
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