| CTRI Number |
CTRI/2025/09/095111 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
18/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of 2 drugs ( Ropivacaine and Bupivacaine) in spinal anaesthesia to evaluate effect on post operative urine retention in patients undergoing after surgery for Varicose veins |
|
Scientific Title of Study
|
Comparison of Equipotent Doses of Hyperbaric Ropivacaine and Bupivacaine in Spinal Anaesthesia to Evaluate Effect on Postoperative Urinary Retention in Patients Undergoing Endovenous Laser Ablation for Varicose Veins: A Randomised 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 Udita Naithani |
| Designation |
Senior Professor |
| Affiliation |
Rabindranath Tagore Medical College |
| Address |
Dept of Anaesthesiology, Rabindranath Tagore Medical College, Udaipur, Rajasthan 313001 India
Udaipur
RAJASTHAN
313001
India |
| Phone |
9829414752 |
| Fax |
|
| Email |
uditanaithani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Udita Naithani |
| Designation |
Senior Professor |
| Affiliation |
Rabindranath Tagore Medical College |
| Address |
Dept of Anaesthesiology, Rabindranath Tagore Medical College, Udaipur, Rajasthan 313001 India
Udaipur
RAJASTHAN
313001
India |
| Phone |
9829414752 |
| Fax |
|
| Email |
uditanaithani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mrinalini Yadav |
| Designation |
Pg Resident |
| Affiliation |
Rabindranath Tagore Medical College |
| Address |
Dept of Anaesthesiology, Rabindranath Tagore Medical College, Udaipur, Rajasthan 313001 India
Udaipur
RAJASTHAN
313001
India |
| Phone |
7726963735 |
| Fax |
|
| Email |
mrinaliniydv7139@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rabindranath Tagore Medical College |
| Address |
Department of Anaesthesiology Rabindranath Tagore 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 Mrinalini Yadav |
Rabindranath Tagore Medical College Udaipur |
Cardio thoracic vascular surgery operation theatre at RNT Medical College Udaipur Rajasthan
Udaipur
RAJASTHAN |
7726963735
mrinaliniydv7139@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC MEDICAL COLLEGE RESEARCHER AND CONTROLLER UDAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I832||Varicose veins of lower extremities with both ulcer and inflammation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hyperbaric Bupivacain |
Hyperbaric Bupivacaine 0.5% (2.5ml) intrathecally in EVLA surgery |
| Comparator Agent |
Hyperbaric Ropivacaine |
Hyperbaric Ropivacaine 0.75% (2.5ml) intrathecally in EVLA surgery |
| Intervention |
Ropivacaine vs Bupivacaine |
Comparison of Equipotent doses of hyperbaric inj. Ropivacaine 0.75 percent 2.5 ml and inj. Bupivacaine 0.5 percent 2.5 ml in spinal anaesthesia to evaluate effect on post operative urinary retention in patients undergoing endovenous laser ablation for varicose veins: A Randomised double blind study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-60 years of both sex American society of Anesthesiologists physical status I-II Height 150-175 centimetres Weight 40-90 kilograms |
|
| ExclusionCriteria |
| Details |
Patient refusal
Patient with any contraindication to subarachnoid block like coagulopathies or anticoagulant medication, raised intracranial pressure, local injection site infection, severe stenotic valvular heart disease.
Patients having Pregnancy, neurological, psychiatric, renal calculus, prostatic disease, diabetes with autonomic neuropathy, urinary tract disease
Patients on beta blockers, alpha 2 agonists and diuretics therapy that may interfere with micturition
Any patients with hypertension, cardiac, renal, liver, endocrine, haematological or any coexisting systemic medical comorbidity
Obesity (body mass index more than 30kg per meter square ), opioid drug addiction
Patients who need to be catheterized preoperatively on table by surgeon in view of any coexisting illness, or risk of postoperative urinary retention
History of allergy to study drugs. |
|
|
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 |
| Time to void urine post spinal block measured in minutes |
Time to void urine post spinal block measured in minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Need for urinary catheterisation due to “inability to void urine 8 hours after the surgery despite having distended bladder or earlier if patient being uncomfortable due to POUR (
Complications due to POUR postoperatively such as abdominal pain, nausea. vomiting, hypotension /hypertension, bradycardia /tachycardia, arrhythmia and their treatment
Sensory and motor onset
Maximal level of sensory and motor block
Intraoperative haemodynamic profile
Intraoperative complications such as hypotension, bradycardia, nausea, vomiting, pruritus, shivering
Quality of anaesthesia by four grade scale regarding need of supplementation
Intraoperative and postoperative fluids given |
Upto 24 hours postoperatively |
|
|
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)
|
25/10/2025 |
| 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
|
Our goal is to compare the clinical effectiveness and safety profile of equipotent doses of available commercial preparations of hyperbaric ropivacaine (0.75 percent) versus hyperbaric bupivacaine (0.5 percent ) using a fixed dose of 2.5ml in two groups for spinal anaesthesia in patients undergoing EVLA to compare effect on post operative urinary retention in terms of time to void urine post spinal block |