| CTRI Number |
CTRI/2020/12/030073 [Registered on: 28/12/2020] Trial Registered Prospectively |
| Last Modified On: |
24/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
to compare the effect of placing an erector spinae block with peri nehrostomy tube local infiltration as a pain relief technique during percutaneous surgery for renal stone |
|
Scientific Title of Study
|
Comparison of efficacy of ultrasound guided erector spinae plane block to peri tubal infiltration of local anaesthetic for perioperative analgesia in percutaenous nephrolithotomy surgery.A randomised clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rishu |
| Designation |
junior resident |
| Affiliation |
PGIMER Chandigarh |
| Address |
Office of Department of anaesthesia, 4th floor, Nehru hospital, PGIMER,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8894883396 |
| Fax |
|
| Email |
rishu.chaudhary1988@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prerna Varma |
| Designation |
Assistant professor |
| Affiliation |
PGIMER |
| Address |
Office of Department of anaesthesia, 4th floor, Nehru hospital, PGIMER,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9654238627 |
| Fax |
|
| Email |
prerna.varma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prerna Varma |
| Designation |
Assistant professor |
| Affiliation |
PGIMER |
| Address |
Office of Department of anaesthesia, 4th floor, Nehru hospital, PGIMER,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9654238627 |
| Fax |
|
| Email |
prerna.varma@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DIRECTOR PGIMER |
| Address |
PGIMER Chandigarh sec 12 Chandigarh 160012 |
| 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 |
| PRERNA VARMA |
UROLOGY OPERATION THEATRE, MAIN OT COMPLEX, 4TH FLOOR, NEHRU HOSPITAL, PGIMER, CHANDIIGARH |
OFFICE OF DEPARTMENT OF ANAESTHESIA, MAIN OPERATION THEATRE COMPLEX, 4th FLOOR, NEHRU HOSPITAL, PGIMER CHANDIGARH -160012-160012
Chandigarh
CHANDIGARH |
7087003391
prerna.varma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institute ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N202||Calculus of kidney with calculus of ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
PERITUBAL INFILTRATION |
Infiltration of local anaesthetic in the track before starting of surgery and at the end of surgery local infiltration around the nephrostomy tube |
| Intervention |
ultrasound guided erector spinae plane block |
local anaesthesia placed in the erector spinae myofascial plane under ultrasound guidance |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA classes 1 &2
scheduled for first stage unilateral PCNL- to extract stones ,from the upper ureter and the pelvicalyceal system |
|
| ExclusionCriteria |
| Details |
patient unable to understand
hepatic /renal dysfunction
coagulation disorders
sepsis
history of allergy to drug used in study
morbid obesity |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TIME TO FIRST RESCUE ANALGESIC REQUIREMENT |
IMMEDIATE POSTOPERATIVE PERIOD |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
TOTAL INTRAOPERATIVE OPIOID USAGE
TOTAL POSTOPERATIVE ANALGESIC CONSUMPTION IN 24 HOURS |
0,2,6,12 ,24 HOURS |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
the study will be conducted in the urology operation theatre of PGIMER, Chandigarh in ASA 1, 2 patients of urolithiasis planned for percutaneous nephrolithotomy surgeries. in the two groups, one group would receive ultrasound guided erector spina plane block with local anaesthetic and second group will receive local anaesthesia infiltration along the nephrostomy tube and track. patients will be assessed for postoperative pain scores and 24 hours opioid consumption in the first 24 hours post surgery. |