| CTRI Number |
CTRI/2022/12/047972 [Registered on: 08/12/2022] Trial Registered Prospectively |
| Last Modified On: |
25/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To evaluate the analgesic efficacy of transmuscular quadratus lumborum block in percutaneous nephrolithotomy |
|
Scientific Title of Study
|
A prospective randomised double-blinded study to evaluate the analgesic efficacy of transmuscular quadratus lumborum block 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 |
Baraniya PA |
| Designation |
junior resident |
| Affiliation |
Sri Ramachandra institute of higher education and research |
| Address |
sri Ramachandra institute of higher education and research,Ramachandra nagar,Porur,Chennai
Porur, Chennai-600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9952994875 |
| Fax |
|
| Email |
baru231995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAruna Parameshwari |
| Designation |
head of the department(Anesthesiology) |
| Affiliation |
head of the department(Anesthesiology),Sri Ramachandra institute of higher education and research |
| Address |
sri Ramachandra institute of higher education and research,Ramachandra nagar,Porur,Chennai
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
9840529863 |
| Fax |
|
| Email |
reetharun@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Baraniya Pandirajan |
| Designation |
junior resident |
| Affiliation |
Sri Ramachandra institute of higher education and research |
| Address |
sri Ramachandra institute of higher education and research,Ramachandra nagar,Porur,Chennai
sri Ramachandra institute of higher education and research,Ramachandra nagar,Porur,Chennai
Kancheepuram
TAMIL NADU
600095
India |
| Phone |
09952994875 |
| Fax |
|
| Email |
baru231995@gmail.com |
|
|
Source of Monetary or Material Support
|
| sriramachandra institute of higher education and research |
|
|
Primary Sponsor
|
| Name |
Baraniya Pandirajan |
| Address |
C-1 12,Dabc Abhinayam phase-3, sriramnagar mainroad, Nolambur, chennai -600095 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Baraniya |
Sri Ramachandra institute of higher education and research |
Urology OT,4th floor,Sri Ramachandra medical College and research institute,Porur, Chennai -600116
Kancheepuram
TAMIL NADU |
9952994875
baru231995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee-SriRamachandra institute of higher education and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N209||Urinary calculus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bupivacaine |
0.25% 20ml given once as Transmuscular quadratus lumborum block under ultrasound guidance at beginning of surgery post intubation and patient will be followed up for 24hours |
| Comparator Agent |
Normal saline |
20ml given once under ultrasound guidance into fascial plane between Quadratus lumborum and Psoas muscle at beginning of surgery post intubation and patient will be followed up for 24hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patient age >18yrs
ASA status 1,2
Elective percutaneous nephrolithotomy
|
|
| ExclusionCriteria |
| Details |
Refusal to participate in the study
Age <18yrs
ASA 4 & 5
Known coagulation disorder
Allergy to local Anaesthetics
Unconscious or mentally incompetent
Pregnancy & hemodynamic instability |
|
|
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 2 groups,
Cumulative tramadol consumption.
|
0h(immediate post extubation);15min,1h,2h,4h,6h,8h,14h,20h,24h
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessing theanalgesic efficacy of quadratus lumborum block postoperatively |
Assessing theanalgesic efficacy of quadratus lumborum block postoperatively at 15mins,1hr,2hr in PACU and every 2nd hourly for 8hr and every 6th hourly for 24hours |
to observe the changes in hemodynamic parameters intraoperatively such as heart rate,systolic and diastolic blood pressure
|
to observe the changes in hemodynamic parameters intraoperatively such as heart rate,systolic and diastolic blood pressure in response to port incision |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
15/12/2022 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Randomised double-blinded study- Transmucular quadratus lumborum block QL3(20ml of 0.25% Bupivacaine in Group A,20ml of saline in Group B) in percutaneous nephrolithotomy to measure postoperative requirement of analgesic Inj.Tramadol
|