| CTRI Number |
CTRI/2025/01/079440 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparison of ropivacaine (hyperbaric) with bupivacaine (hyperbaric) in spinal block in patient posted for surgery around the anus |
|
Scientific Title of Study
|
Comparative Evaluation Of Equipotent Doses of Hyperbaric Bupivacaine And Ropivacaine In Perianal Surgeries a prospective randomized parallel group 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 Banwari Lal Mehra |
| Designation |
PG student |
| Affiliation |
RNT medical College |
| Address |
Department of Anaesthesiology, RNT Medical college ,Udaipur ,Rajasthan
Department of Anaesthesiology, RNT Medical college ,Udaipur ,Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9829370866 |
| Fax |
|
| Email |
blmehra914@gmail.com |
|
Details of Contact Person
Public 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 |
|
|
Source of Monetary or Material Support
|
| RNT medical college Department 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
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hemraj Tungaria |
RNT medical college Udaipur Rajasthan 313001 |
Main operation theatre 3rd floor Maharana bhupal hospital Udaipur Rajasthan
Udaipur
RAJASTHAN |
9829370866
htungaria@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: K600||Acute anal fissure, (3) ICD-10 Condition: K610||Anal abscess, , (4) ICD-10 Condition: K603||Anal fistula, (5) ICD-10 Condition: K601||Chronic anal fissure, (6) ICD-10 Condition: K602||Anal fissure, unspecified, (7) ICD-10 Condition: K605||Anorectal fistula, (8) ICD-10 Condition: K612||Anorectal abscess, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hyperbaric Bupivacaine |
intrathecal Hyperbaric Bupivacaine 1.5 ml of 0.5% (7.5 mg) for saddle block |
| Comparator Agent |
Hyperbaric ropivacaine |
intrathecal Hyperbaric Ropivacaine 1.5 ml of 0.75% (11.25 mg) for saddle block |
| Intervention |
Intratracheal hyperbaric bupivacaine and hyperbaric ropivacaine |
Comparison of hyperbaric bupivacaine 0.5 % 1.5 ml and hyperbaric ropivacaine 0.75 % 1.5 ml in perianal surgeries |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with ASA physical status Grade I and II o posted for perianal surgeries under saddle block |
|
| ExclusionCriteria |
| Details |
Patients refusal to participate in study, Patients having any absolute contraindications for saddle block eg coagulation abnormalities, platelet count less then 70,000, INR greater then 1.5, or on anticoagulants, Pregnant patient, Patients having systemic illness (like severe hypovolemia, raised intracranial pressure, neuromuscular diseases, ischemic/ valvular/ congenital heart diseases, psychiatric, hematological disorder).Any allergy to local anaesthetic, Short stature (height less then 150cm)with spinal deformity.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of sensory block |
Postoperative 6 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study durations analgesia
To study duration of motor block
To study block characteristics
to study side effect intraoperative and postoperative |
up to 24 hours post operatively |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/02/2025 |
| 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 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
|
My clinical study is comparasion of anaesthetic effects of intra thecal hyperbaric bupivacaine with hyperbaric ropivacaine in perianal surgeries in terms of durations of sensory block kindly consider it for CTRI registrations . |