| CTRI Number |
CTRI/2024/11/076389 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative study of efficacy of two drugs Ropivacaine and Bupivacaine ,both with same additive Fentanyl for perineal surgeries under spinal anesthesia |
|
Scientific Title of Study
|
Comparison Of Intrathecal Hyperbaric Bupivacaine with Fentanyl Versus Hyperbaric Ropivacaine with fentanyl for perineal surgeries under Subarachnoid block : A Randomised controlled 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 |
DrGayathri K V |
| Designation |
Postgraduate Resident |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Anaesthesiology Bangalore Medical College and Research Institute, K R Road Fort Bangalore
Bangalore KARNATAKA 560002 India |
| Phone |
6361763099 |
| Fax |
|
| Email |
gayathrivijay.k@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Dayananda V P |
| Designation |
Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Anaesthesiology Bangalore Medical College and Research Institute K R Road Fort Bangalore
Bangalore KARNATAKA 560002 India |
| Phone |
919845161826 |
| Fax |
|
| Email |
Vpd921@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
DrDayananda V P |
| Designation |
Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Anaesthesiology Bangalore Medical College and Research Institute K R road Fort Bangalore
Bangalore KARNATAKA 560002 India |
| Phone |
919845161826 |
| Fax |
|
| Email |
Vpd921@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Bangalore Medical College and Research Institute
Fort
Krishna Rajendra Road
Kalasipalaya
Bengaluru
Karnataka
560002 |
|
|
Primary Sponsor
|
| Name |
Bangalore Medical College and Research Institute |
| Address |
Bangalore Medical College and Research Institute
K R Road Fort Bangalore
560002 |
| 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 Gayathri K V |
Bangalore Medical College and Research Institute |
Department of Anaesthesiology Bangalore Medical College and Research Institute KR Road Fort Bangalore Bangalore KARNATAKA |
6361763099
gayathrivijay.k@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore Medical College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N476||Balanoposthitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injection Bupivacaine heavy 0.5% with Injection Fentanyl 25mcg intrathecally for perineal surgeries |
Bupivacaine heavy 0.5% 2cc with Fentanyl 25mcg given intrathecally for subarachnoid block in patients undergoing perineal surgeries , administered once , duration 2 hours 30 minutes |
| Intervention |
Injection Ropivacaine Heavy 0.75% with Injection Fentanyl 25mcg intrathecally for perineal surgeries |
Ropivacaine heavy 0.75% 2cc with Fentanyl 25mcg given intrathecally for subarachnoid block in patients undergoing perineal surgeries , frequency once , duration 2 hours 30 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Societ of Anaesthesiologists (ASA) Grade 1 and 2 patients undergoing perineal surgeries under subarachnoid block |
|
| ExclusionCriteria |
| Details |
Patients refusing to participate in study
Patients with history of hypersensitivity to local anesthetics
Emergency cases and cases with ASA Grade 3 or above
Patients with sepsis in Lumbar region,Patients with pre-existing neurological disorders or spine deformity
Surgeries involving major blood loss |
|
|
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 |
Time for sensory blockade at T10
Time for highest sensory blockade
Time for complete Motor blockade
Hemodynamic parameters |
Every one minute
Every one minute
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time for complete Motor regression
Time for complete sensory regression
Time for post operative voluntary micturition |
Every 2 hours until 6 hours
Every 2 hours until 6 hours |
|
|
Target Sample Size
|
Total Sample Size="88" Sample Size from India="88"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
26/11/2024 |
| Date of Study Completion (India) |
30/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/08/2025 |
|
Estimated Duration of Trial
|
Years="0" Months="8" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Subarachnoid block is commonly practiced worldwide as a standard of care for perineal, lower abdominal and lower limb surgeries. It has been proven that combination of adjuvants to local anaesthetic prolong duration of analgesia postoperatively.Ropivacaine has high pka, low lipid solubility[3].It is found to block sensory nerves to a greater degree than motor nerves .Ropivacaine and Bupivacaine have similar local anesthetic properties and chemical structure[1][4]. Ropivacaine is expected to be a suitable drug for day care surgeries because of less motor block with great sensory motor dissociation and could be associated with early post-operative mobilization. The concept of day-care or ambulatory surgery has been well established in developed countries though it is still in its infancy in developing countries such as India. There is an immense opportunity for expansion in day-care surgery in India with it’s huge population of 1.2 billion and expanding private sector . In India, there is lack of studies with proper documentation regarding day-care anaesthesia . 11%–23% of the surgeries in India performed in hospital settings are considered to be on outpatient basis based on available data from unpublished source. The study aims to compare relatively novel drug ropivacaine with bupivacaine in it’s effectiveness in terms of duration of anaesthesia , intraoperative quality of block and post operative recovery in perineal surgeries , a ususal form of ambulatory surgery. The identification of a suitable drug for ambulatory surgeries would help in popularizing the method of surgery and would cut down cost ,easy return to work , lack of dependency on availability of hospital beds, reduced nosocomial infection rates for patients.
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