| CTRI Number |
CTRI/2022/06/043446 [Registered on: 23/06/2022] Trial Registered Prospectively |
| Last Modified On: |
24/06/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
Comparison of segmental spinal and lumbar spinal anaesthesia for Endoscopic surgery for kidney stone removal |
|
Scientific Title of Study
|
Comparison of low thoracic segmental spinal anaesthesia and lumbar spinal anaesthesia for PCNL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swati choudhary |
| Designation |
Assistant professor |
| Affiliation |
JNUIMSRC, Jaipur |
| Address |
OT complex, JNUIMSRC, jagatpura
Jaipur
RAJASTHAN
302017
India |
| Phone |
9460861238 |
| Fax |
|
| Email |
drswati90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati choudhary |
| Designation |
Assistant professor |
| Affiliation |
JNUIMSRC, Jaipur |
| Address |
OT complex, JNUIMSRC, jagatpura
Jaipur
RAJASTHAN
302017
India |
| Phone |
9460861238 |
| Fax |
|
| Email |
drswati90@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati choudhary |
| Designation |
Assistant professor |
| Affiliation |
JNUIMSRC, Jaipur |
| Address |
OT complex, JNUIMSRC, jagatpura
Jaipur
RAJASTHAN
302017
India |
| Phone |
9460861238 |
| Fax |
|
| Email |
drswati90@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JNUIMSRC |
| Address |
JNUIMSRC, jagatpura, jaipur |
| 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 |
| Dr swati choudhary |
JNUIMSRC |
OT complex, anaesthesia department, JNUIMSRC, jagatpura
Jaipur
RAJASTHAN |
9460861238
drswati90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Jaipur national university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N20||Calculus of kidney and ureter, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hyperbaric ropivacaine 0.75% |
For lumbar spinal anaesthesia |
| Intervention |
Isobaric ropivacaine 0.75% |
For low thoracic segmental anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Covid negative patients |
|
| ExclusionCriteria |
| Details |
BMI > 37kgm2
Pregnant and lactating females
Bleeding disorders
Local site infections |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Onset and duration of motor and sensory block
Hemodynamic variations
Any intraoperative and postoperative side effect |
At 5 min interval, during PCNL surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time of rescue analgesia
Surgeon and patient satisfaction score |
The time at which rescue analgesia is required (vas3) will be noted and compared.
Surgeon and patient satisfaction score in both the techniques will be compared. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
Modification(s)
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This prospective randomised comparative study is designed to compare low thoracic segmental spinal anaesthesia with isobaric ropivacaine 0.75% and lumbar spinal anaesthesia with hyperbaric ropivacaine 0.75% in PCNL surgeries. |