FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/12/029997 [Registered on: 23/12/2020] Trial Registered Prospectively
Last Modified On: 19/12/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of erector spinae plane block for post operative pain after percutaneous nephrolithotomy. 
Scientific Title of Study   Efficacy of erector spinae plane block versus peritubal analgesic infiltration for post operative pain following percutaneous nephrolithotomy: A prospective randomized trial.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dinesh J Prajapati 
Designation  Consultant Anesthesiologist 
Affiliation  Muljibhai Patel Urological Hospital 
Address  Dr Virendra desai road, Nadiad
Near Sardar bridge,
Kheda
GUJARAT
387001
India 
Phone  02682520323  
Fax    
Email  dr_djp2011@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dinesh J Prajapati 
Designation  Consultant Anesthesiologist 
Affiliation  Muljibhai Patel Urological Hospital 
Address  Dr Virendra Desai Road,
Near Sardar bridge
Kheda
GUJARAT
387001
India 
Phone  09879399866  
Fax    
Email  dr_djp2011@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dinesh J Prajapati 
Designation  Consultant Anesthesiologist 
Affiliation  MULJIBHAI PATEL UROLOGICAL HOSPITAL 
Address  Dr Virendra Desai Road
Near Saradar Bridge
Kheda
GUJARAT
387001
India 
Phone  09879399866  
Fax    
Email  dr_djp2011@hotmail.com  
 
Source of Monetary or Material Support  
Muljibhai Patel Urological Hospital, Nadiad  
 
Primary Sponsor  
Name  Muljibhai Patel Urological Hospital Nadiad 
Address  Near Dr Virendra Desai Road, Nadiad-387001 
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 Shailesh Soni  Muljibhai Patel Urological Hospital  Department of Anesthesia
Kheda
GUJARAT 
02682520323

sonishail@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Muljibhai Patel Society for Research in Nephro-Urology 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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group C  Received standard anesthesia 
Intervention  Group E ( Erector spinae plan block)  Received inj Rupivacaine 0.375% 20ml under USG guided ESP ( Erector spinae plan) Block 
Intervention  Group P ( Peritubal Infiltration)  Received inj Rupivacaine 0.375% 20ml under fluoroscopy guided peritubal infiltration. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients with American Society of Anesthesiologists (ASA) physical status classes I or II,
2.Aged 18–65 years
3.Scheduled for all unilateral PCNL, Mini PCNL and Tubeless PCNL under General anesthesia (GA)
 
 
ExclusionCriteria 
Details  1.Psychological disorders,
2.Morbid obesity ( BMI>35), hepatic or renal dysfunction,
3.Coagulation disorders,
4.Sepsis, history of chronic analgesic use
5.History of allergy to local anesthetic agents
6.Restage PCNL
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the analgesia efficacy by visual analogue scale and need of rescue analgesia  24 hours after procedure postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the hemodynamic stability, duration of analgesia and total dosage of analgesia consumption  24 hours after procedure postoperatively 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   01/01/2021 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL  
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 commonly performed to treat the kidney stone. There are several effort has been done to minimise the postoperative pain such as multimodal analgesic regimens.[1-3]  Ultrasound-guided erector spinae plane block (ESPB) is a novel interfascial paraspinal plane regional anesthesia technique, which was first used by Forero et al for the treatment of severe chronic thoracic neuropathic pain.[4]. Although the majority of ESPBs described were in the thoracic region and few studies available for the lumbar region for postoperative analgesia.[5]  The studies reported that it was an effective technique for postoperative analgesia in patients having ventral hernia repair [6], breast surgery [7], laparoscopic cholecystectomy procedures [8] and PCNL[9, 10]. The peritubal infiltration along the renal capsule, subcutaneous tissue, skin and nephrostomy tube is carried out after PCNL is another effective method for postoperative analgesia.[11] There was no reported study for comparison of ESPB versus peritubal infiltration for postoperative analgesia for PCNL. The aim of this randomized, controlled, single-blinded study was to compare the analgesic efficacy of ultrasound-guided ESPB versus peritubal infiltration versus no intervention.

 
Close