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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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