| CTRI Number |
CTRI/2024/07/070399 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
05/07/2024 |
| 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 compare thoracic segmental and lumbar spinal block in patients undergoing kidney stone removal. |
|
Scientific Title of Study
|
Comparative evaluation of efficiency of thoracic segmental versus lumbar subarachnoid block in patients undergoing percutaneous nephrolithotomy. |
| 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 Vinita Kisku |
| Designation |
Post Graduate Student |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
Department of Anaesthesiology ESIC Medical College and Hospital NH3 NIT
Faridabad
Faridabad
HARYANA
121001
India |
| Phone |
8102464070 |
| Fax |
|
| Email |
sonuvinita2112@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jaspal Singh Dali |
| Designation |
Professor |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
ESIC Medical College and Hospital NH3 NIT
Faridabad
Faridabad
HARYANA
121001
India |
| Phone |
9818032649 |
| Fax |
|
| Email |
dr_dali@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinita Kisku |
| Designation |
Post Graduate Student |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
Department of Anaesthesiology ESIC Medical College and Hospital NH3 NIT
Faridabad
Faridabad
HARYANA
121001
India |
| Phone |
8102464070 |
| Fax |
|
| Email |
sonuvinita2112@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC Medical College and Hospital NH3 NIT Faridabad Haryana India PIN-121001 |
|
|
Primary Sponsor
|
| Name |
ESIC Medical College and Hospital |
| Address |
ESIC Medical College and Hospital NH3 NIT
Faridabad Haryana 121001 |
| Type of Sponsor |
Government 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 |
| Dr Vinita Kisku |
ESIC Medical College and Hospital |
Department of Anaesthesiology OT Complex 3rd Floor OPD building
Faridabad
HARYANA |
8102464070
sonuvinita2112@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ESIC Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, (2) ICD-10 Condition: N200||Calculus of kidney, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Lumber subarachnoid block |
I will compare the efficacy of lumber subarachnoid block versus thoracic segmental block in patients undergoing percutaneous nephrolithotomy |
| Intervention |
Thoracic segmental block |
I will compare the efficacy thoracic segmental versus lumber subarachnoid in patients undergoing percutaneous nephrolithotom.Duration of intervention will be time taken to perform the block and patient will be monitored throughout the surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult Patients of Age 18-60 years with American Society of Anaesthesiologist physical status 1 and 2 of either sex posted for elective percutaneous nephrolithotomy |
|
| ExclusionCriteria |
| Details |
Patients with relative and absolute contraindications of spinal anaesthesia Parturient and lactating females Patients with BMI more than 30kg per metre square and expected duration of surgery more than 2 hours |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Compare the incidence of hypotension Within 10 minutes following thoracic segmental and lumber subarachnoid block |
Every minute for first 10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate & compare the incidence of hypotension incidence of bradycardia spinal block characteristics total dose of ephedrine duration of analgesia in both the groups |
Every one minute in first ten minutes then every five minutes till the completion of surgery |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
20/07/2024 |
| 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="3"
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
|
I, Dr Vinita Kisku, postgraduate student at ESIC medical college and hospital, Faridabad, Haryana will be performing procedures for my thesis which aim to compare the efficacy of thoracic segmental block and lumber subarachnoid block in patients undergoing percutaneous nephrolithotomy which include comparing the incidence of hypotension, bradycardia, time to achieve motor block, duration of analgesia, two segment regression time of sensory block, requirement of rescue analgesia in both the groups. |