FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/09/057665 [Registered on: 15/09/2023] Trial Registered Prospectively
Last Modified On: 13/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of ropivacaine (hyperbaric) with or without adjuvant (fentanyl) in spinal block in patient posted for surgery around the anus. 
Scientific Title of Study   Comparative Evaluation Of Anaesthetic Effects Of Intra Thecal Hyperbaric Ropivacaine 0.75% With Or Without Fentanyl In Perianal Surgery: A Randomized Double-Blind Study 
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 Hemraj Tungaria 
Designation  associate professor 
Affiliation  rnt medical college 
Address  Department of Anaesthesiology, RNT Medical College.Udaipur,Rajasthan

Udaipur
RAJASTHAN
313001
India 
Phone  9829370866  
Fax    
Email  htungaria@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Hemraj Tungaria 
Designation  associate professor 
Affiliation  rnt medical college 
Address  Department of Anaesthesiology, RNT Medical College.Udaipur,Rajasthan

Udaipur
RAJASTHAN
313001
India 
Phone  9829370866  
Fax    
Email  htungaria@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Deepak Mehra 
Designation  Pg Resident 
Affiliation  RNT Medical College 
Address  Department of Anaesthesiology, RNT Medical College.Udaipur,Rajasthan

Udaipur
RAJASTHAN
313001
India 
Phone  7737862803  
Fax    
Email  mehra007mehra@gmail.com  
 
Source of Monetary or Material Support  
RNT medical college Departement of anaesthesiology 
 
Primary Sponsor  
Name  RNT Medical college 
Address  Department of Anaesthesiology RNT Medical College, Udaipur Rajasthan 313001 
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 Deepak Mehra  RNT medical college udaipur rajasthan 313001  Main operation theatre 3rd floor Maharana bhupal hospital Udaipur Rajasthan
Udaipur
RAJASTHAN 		 7737862803

mehra007mehra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RNT MEDICAL COLLEGE AND CONTROLLER AND ATTACHED HOSPITALS UDAIPUR   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: K620||Anal polyp, (3) ICD-10 Condition: K600||Acute anal fissure, (4) ICD-10 Condition: K601||Chronic anal fissure, (5) ICD-10 Condition: K602||Anal fissure, unspecified, (6) ICD-10 Condition: K603||Anal fistula, (7) ICD-10 Condition: K605||Anorectal fistula, (8) ICD-10 Condition: K610||Anal abscess, (9) ICD-10 Condition: K612||Anorectal abscess,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Hyperbaric ropivacaine with fentanyl  Hyperbaric ropivacaine 0.75% 1ml with 0.5ml(25mcg) fentanyl intrathecally in saddle block in perianal surgery 
Comparator Agent  Hyperbaric ropivacaine without fentanyl  Hyperbaric ropivacaine 0.75% 1.5ml intrathecally in saddle block in perianal surgery 
Intervention  Intrathecal ropivacaine heavy with or without fentanyl  Comparison of Intrathecal hyperbaric ropivacaine 0.75% 1.5 ml and hyperbaric ropivacaine 0.75% -1 ml with 0.5ml(25 mcg) fentanyl in perianal surgery  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with ASA physical status Grade I and II
Posted for perianal surgeries under saddle block. 
 
ExclusionCriteria 
Details  Pregnant patients.
Patients having coagulation abnormalities, platelet count <70,000, INR >1.5, or on anticoagulants.
Patients having systemic illness (like severe hypovolemia, raised intracranial pressure, neuromuscular diseases, ischemic/ valvular/ congenital heart diseases, psychiatric, hematological disorder).
Patients having any absolute contraindications for spinal anaesthesia.
Patient refusal to participate in study
 
 
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 
Duration of analgesia  Up to 6 hour post operatively 
 
Secondary Outcome  
Outcome  TimePoints 
To study block characteristics.
To study hemodynamic variables.
To study Side effects / Complications
 		 Up to 24 hour post operatively 
 
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   Phase 4 
Date of First Enrollment (India)   25/09/2023 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

My clinical study is  Comparasion of  anaesthetic effects of   intra thecal hyperbaric ropivacaine 0.75% with or without fentanyl in perianal surgery  in terms of duration of analgesia block characteristic and side effect kindly consider it for CTRI registration.

 
Close