| CTRI Number |
CTRI/2022/05/042829 [Registered on: 26/05/2022] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pain relief for kidney stone procedure pcnl with erector spinae plane block in the back and local infiltration with 0.375% ropivacaine at procedure site |
|
Scientific Title of Study
|
Comparison of erector spinae plane block and local anaesthetic
infiltration of the incision site with 0.375% ropivacaine for postoperative analgesia in percutaneous
nephrolithotomy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Renganathan S |
| Designation |
Assistant professor |
| Affiliation |
velammal medical college |
| Address |
Department of Anaesthesiology,velammal medical college and research institute
Madurai
TAMIL NADU
625009
India |
| Phone |
9500025879 |
| Fax |
|
| Email |
renganathansockalingam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Renganathan S |
| Designation |
Assistant professor and guide for pg thesis |
| Affiliation |
velammal medical college |
| Address |
Department of Anaesthesiology,velammal medical college and research institute
Madurai
TAMIL NADU
625009
India |
| Phone |
9500025879 |
| Fax |
|
| Email |
renganathansockalingam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Naveen Raj R |
| Designation |
post graduate |
| Affiliation |
velammal medical college |
| Address |
Room number 2,Department of anaesthesia,near MOT Complex,velammal medical college,velammal Village, Madurai - Tuticorin, ring Road, Anuppanadi, Tamil Nadu 625009
Madurai
TAMIL NADU
625009
India |
| Phone |
9677685941 |
| Fax |
|
| Email |
dr76939@gmail.com |
|
|
Source of Monetary or Material Support
|
| Velammal medical college and research institute |
|
|
Primary Sponsor
|
| Name |
velammal medical college |
| Address |
Velammal Village, Madurai - Tuticorin, ring Road, Anuppanadi, Tamil Nadu 625009 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Renganathan s |
velammal medical college |
Department of Anaesthesia,Divisiov Main OT Complex,Room number OT 2 and OT 3,Velammal Village, Madurai - Tuticorin, ring Road, Anuppanadi, Tamil Nadu 625009
Madurai
TAMIL NADU |
9500025879
renganathansockalingam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Velammal Medical College Hospital and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Local infiltration with 20ml of 0.375% ropivacaine at percutaneous nephrololithotomy incision site |
At the end of the procedure 20ml of 0.375% ropivacaine was infiltrated in the subcutaneous plane invoving the skin and subcutaneous tissue with 21g hypodermic needle.Duration of surgical procedure is 90mins to 120 mins.Duration of site infiltration is 2 to 3 minutes |
| Intervention |
Ultrasound guided Erector spinae block with 0.375% ropivacaine after percutaneous nephrolithotomy for postoperative analgesia |
USG guided Erector spinae block at T10 vertebra level with 20ml of 0.375% ropivacaine after percurtaneous nephrolithotomy for postoperative analgesia.Duration of USG ESP procedure is between 10 to 20 minutes and total duration of surgical procedure is 90 minutes to 120 minutes
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria - Patients undergoing PCNL under general anaesthesia (GA) of both genders belonging to ASA I and II, between 18 to 70 years of age, were included. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria – ASA – III , IV contraindications to peripheral nerve blocks, body mass index >35 kg/m2, sepsis or bacteraemia, and cognitive disability.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative Numeric rating pain scale |
Postoperative Numeric rating scale 0 to 10 measured over 24 hours post procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative analgesic requirement |
time for first rescue analgesia and total analgesic dose required postoperatively |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2022 |
| Date of Study Completion (India) |
31/10/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Comparison of Postoperative Analgesic Effect of Ultrasound-guided Erector Spinae Plane Block and
Local Anaesthetic Infiltration with 0.375% Ropivacaine in Percutaneous Nephrolithotomy Patients: A
Randomised Clinical Study Journal of Clinical and Diagnostic Research. 2023 Dec, Vol-17(12): UC24-
UC28 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Erector spinae block is found to be effective in variety of procedures.This study is designed to evaluate the efficacy of USG guided Erector spinae block(ESP) for postoperative analgesia following percutaneous nephrolithotomy(pcnl).It is a prospective double blind parallel group study comparing erecor spinae block with local site infiltration with 0.375% ropivacaine for postoperative pain relief for pcnl.Inclusion criteria included ASA 1 and 2 patients aged between 18 and 70 years of both sexes.Exclusion criteria included BMI>35 KG/m2 ,ASA 3 AND 4,allergic history to local anaesthetics,sepsis or bacreimia.Patients in group L received 20ml of 0.375% ropivacaine at the incision site subcutaneously with hupodermic needle locally and Group E received USG guided ESP block with 0.375% ropivacaine at T10 level.Numeric rating pain scale was measured postoperatively at 30 min,60 min then hourly for 6 hours followed by 4th hourly for 24 hours.The primary objective of the study was to compare NRS scores postoperatively between two groups.The secondary objective was to compare the rescue analgesia requirement between both gropus for 24 hours. |