| CTRI Number |
CTRI/2024/07/070578 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
12/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
To Comparison The Efficacy Of Ultrasonography Guided Erector Spinae Plane Block For Postoperative Analgesia In Percutaneous Nephrolithotomy With The Control Group |
|
Scientific Title of Study
|
COMPARISON OF EFFICACY OF ULTRASONOGRAPHY GUIDED ERECTOR SPINAE PLANE BLOCK FOR POSTOPERATIVE ANALGESIA IN PERCUTANEOUS NEPHROLITHOTOMY WITH CONTROL GROUP |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR VAISHALI SAJJAN |
| Designation |
Junior Resident |
| Affiliation |
Sapthagiri Institute Of Medical Sciences and Research Center |
| Address |
Urology OT,4th Floor OT Complex,,Department Of Anaesthesiology , Sapthagiri Institute Of Medical Sciences and Research Center,#15 Chikkasandra,
Hesaraghatta Main Road
Bangalore
KARNATAKA
560090
India |
| Phone |
9449176552 |
| Fax |
|
| Email |
vaishali.r.sajjan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MANJUNATH |
| Designation |
PROFESSOR |
| Affiliation |
Sapthagiri Institute of Medical Science and Research |
| Address |
Urology OT,4th Floor OT Complex,Department Of Anaesthesiology , Sapthagiri Institute Of Medical Sciences and Research Center,#15 Chikkasandra,
Hesaraghatta Main Road
Bangalore
KARNATAKA
560090
India |
| Phone |
8123540084 |
| Fax |
|
| Email |
manjumac5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MANJUNATH |
| Designation |
PROFESSOR |
| Affiliation |
Sapthagiri Institute Of Medical Science and Research |
| Address |
Urology OT,4th Floor OT Complex,Department Of Anaesthesiology , Sapthagiri Institute Of Medical Sciences and Research Center,#15 Chikkasandra,
Hesaraghatta Main Road
Bangalore
KARNATAKA
560090
India |
| Phone |
8123540084 |
| Fax |
|
| Email |
manjumac5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Urology OT,4th Floor OT Complex,Department Of Anaesthesiology , Sapthagiri Institute Of Medical Sciences and Research Center,#15 Chikkasandra,
Hesaraghatta Main Road,
Bangalore,Karnataka,India, 560090 |
|
|
Primary Sponsor
|
| Name |
Sapthagiri Institute Of Medical Science and Research |
| Address |
Sapthagiri Institute Of Medical Sciences and Research Center,#15 Chikkasandra,
Hesaraghatta Main Road,
Bangalore
Karnataka
India
560090 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DrVaishali |
Sapthagiri Institute Of Medical Sciences and Research |
Urology OT,4th Floor OT Complex,Department Of Anaesthesiology , Sapthagiri Institute Of Medical Sciences and Research Center,#15 Chikkasandra,
Hesaraghatta Main Road,
Bangalore,560090
Karnataka
India
Bangalore
KARNATAKA |
9449176552
vaishali.r.sajjan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sapthagiri institute of medical science and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
20ml of 0.5% Inj.Bupivacaine with inj.Dexamethasone 8mg |
| Comparator Agent |
Control group |
No block given |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
American society of anaesthesiology grade 1&2
Patients posted for unilateral PCNL |
|
| ExclusionCriteria |
| Details |
Patients not willing to participate in the study.
Patients with known allergies to study drug.
Contraindications for the subarachnoid block.
Patients on any form of chronic pain medications. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to assess the visual analogue score for pain and to determine the time to first rescue analgesia |
At baseline,2hrs,4hrs,8hrs,12hrs and 24 hours and to determine the time to first rescue analgesia and compare between both groups. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to determine the total analgesic consumption |
24hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
23/07/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The present study is undertaken to determine the efficacy of Ultrasound Guided(USG) Erector Spinae Plane Block used for postoperative pain management among PCNL patients.Patients admitted for Percutaneous Nephrolithotomy who fulfills the inclusion criteria for the study will be randomised using a computer-generated table of random numbers into 2 groups of 30 patients each: Group A received USG guided ESP Block and Group B is control group.Under aseptic precautions,Subarachnoid block will be performed in all patients in L3-L4 space with 3.00ml 0.5% Hyperbaric Bupivacaine.At the end of the surgery,under aseptic precautions, Erector spinae block is given.20 ml of 0.5% Bupivacaine with 8 mg Dexamethasone will be injected. At 1st request, Injection. Paracetomol 1gm IV will be given and continued every 8th hourly thereafter. For rescue analgesia(when VAS>3), Tramadol 1mg/kg will be given.VAS score will be assessed and recorded at 0hrs,2hrs,4hrs,8hrs,12hrs and 24hrs. The time to first rescue analgesia and the total analgesic consumption in 24hrs will be recorded.Statistical analysis will be entered in MS-EXCEL sheet and analysis will be done using Statistical Package for Social Science(SPSS) version 21. Descriptive and inferential statistics will be used for the results . P value of< 0.05 will be considered to be statistically significant |