| CTRI Number |
CTRI/2024/05/067278 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
19/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between thoracic segmental spinal anaesthesia and lumbar spinal anaesthesia in transurethral surgery |
|
Scientific Title of Study
|
Comparative evaluation of segmental spinal anaesthesia with conventional spinal anaesthesia in endoscopic transurethral surgery |
| 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 Prashant Kumar |
| Designation |
Professor |
| Affiliation |
Pt BD Sharma Postgraduate Institute of Medical Sciences |
| Address |
Department of anesthesiology and critical care
Pt BD Sharma Postgraduate Institute of Medical Sciences Rohtak
Haryana
124001
India
Rohtak HARYANA 124001 India |
| Phone |
9416336901 |
| Fax |
|
| Email |
Pk.pgims@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Twinkal kumari |
| Designation |
Junior Resident |
| Affiliation |
Pt BD Sharma Postgraduate Institute of Medical Sciences |
| Address |
Department of anesthesiology and critical care
Pt BD Sharma Postgraduate institute of medical sciences Rohtak
Haryana
124001
India
Rohtak HARYANA 124001 India |
| Phone |
7015305376 |
| Fax |
|
| Email |
yadavtwinkal2@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Twinkal kumari |
| Designation |
junior resident |
| Affiliation |
pgims rohtak |
| Address |
pt bd sharma postgraduate institute of medical sciences Rohtak Haryana
Rohtak HARYANA 124001 India |
| Phone |
7015305376 |
| Fax |
|
| Email |
yadavtwinkal2@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| PT BD sharma PGIMS Rohtak Haryana |
|
|
Primary Sponsor
|
| Name |
Pt BD Sharma University of health sciencesPGIMS Rohtak Haryana |
| Address |
Pt BD Sharma University of health sciences,PGIMS,Rohtak Haryana |
| 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 Twinkal Kumari |
Pt BD Sharma,PGIMS, Rohtak |
Department of anesthesiology and critical care Rohtak HARYANA |
7015305376
yadavtwinkal2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BioMedicl Research Ethics Committee, PGIMS, Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N37||Urethral disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
segmental spinal anaesthesia |
1ml of 0.5% isobaric ropivacaine and 20 ug fentanyl in segmental spinal anaesthesia |
| Comparator Agent |
spinal anaesthesia |
spinal anaesthesia with 2ml of 0.5% hyperbaric ropivacaine and 20 ug fentanyl |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients in the age group 18 to 70 years of either gender, belonging to American society of anaesthesiologist (ASA) physical status 1and 2 scheduled for endoscopic urology study will be included will recieve 1ml of 0.5% isobaric ropivacaine and 20 ug fentanyl in segmental spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
Patients in the age group 18 to 70 years of either gender, belonging to American society of anaesthesiologist (ASA) physical status 1and 2 scheduled for endoscopic urology study will be included will receive spinal anaesthesia with 2ml of 0.5% hyperbaric ropivacaine and 20 ug fentanyl |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Upper level of sensory blockade
2.Motor blockade
3.Hemodynamic parameters
|
1.1minutes,2minutes,3minutes,4 minutes,5minutes,10 minutes,15minutes,30minutes,45minutes
2.Motor blockade at 10 minutes of subarachnoid block and at the end of surgery
3.Hemodynamic parameters at baseline,1minutes,2 minutes,3minutes,4minuted,5minutes,10 minutes,15 minutes,30 minutes,45 minutes,55 minutes, 55 minutes,upto 15 minutes after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time of first rescue analgesia
Patient’s and surgeon’s satisfaction scores
|
2 hour, 6 hour and 24 hour |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
24/05/2024 |
| 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="1" 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
|
There are a number of advantages of thoracic segmental spinal anaesthesia firstly, there is no sympathetic blockade of lower limbs causing significantly lesser venodilation in the lower extremities and therefore there is lesser decrease in the preload to heart which provides better hemodynamic stability. Secondly, nerve roots in the thoracic segments of spinal cord are thinner,as well as the amount of CSF at thoracic levels is comparatively less, which favours efficient blockade with lower doses of anaesthetic drugs. Thirdly, the patients have motor control over their legs during the surgery and patients exhibit a better level of satisfaction and decreased anxiety during the procedure.Various studies have concluded that segmental spinal anaesthesia is a safe and effective method for many surgeries like laparoscopic cholecystectomies, breast cancer lumpectomies, and abdominal cancer surgeries. However, this technique in endoscopic transurethral surgeries remains unacknowledged. Encouraged by the results of above studies, we plan to study the efficacy of using segmental spinal anaesthesia as the sole regional anaesthetic technique for endoscopic transurethral surgery. We hypothesized that segmental spinal anaesthesia could be a potential alternative to spinal anaesthesia for patients undergoing transurethral surgery. |