| CTRI Number |
CTRI/2025/10/095861 [Registered on: 10/10/2025] Trial Registered Prospectively |
| Last Modified On: |
03/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing two medicines (bupivacaine and ropivacaine) used for spinal anesthesia in patients undergoing surgery, to see which works better and is safer |
|
Scientific Title of Study
|
A comparative study between hyperbaric ropivacaine and hyperbaric bupivacaine for spinal anaesthesia in infra-umbilical surgeries in a tertiary care centre in Manipur |
| 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.Thounaojam Dinesh Singh |
| Designation |
MD Anaesthesiology HOD and Senior Consultant |
| Affiliation |
Shija Hospitals and Research Institute |
| Address |
Singjamei Thongam Leikai
Lane no.10
Imphal West
Manipur
Shija Hospitals and Research Institute,Lamphel, Imphal west,Anaesthesia Department , 1st floor.
Imphal West
MANIPUR
795001
India |
| Phone |
9863122865 |
| Fax |
|
| Email |
drthdinesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Thounaojam Dinesh Singh |
| Designation |
MD Anaesthesiology HOD and Senior Consultant |
| Affiliation |
Shija Hospitals and Research Institute |
| Address |
Singjamei Thongam Leikai
Lane no.10
Imphal West
Manipur
Shija Hospitals and Research Institute,Lamphel, Imphal west,Anaesthesia Department , 1st floor.
Imphal West
MANIPUR
795001
India |
| Phone |
9863122865 |
| Fax |
|
| Email |
drthdinesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Thoudam Chandish Singh |
| Designation |
DNB Anaesthesiology |
| Affiliation |
Shija Hospitals and Research Institute |
| Address |
Shija Hospitals and Research Institute,Lamphel, Imphal west,Anaesthesia Department , 2nd floor.
MANIPUR
795008
India |
| Phone |
8414867624 |
| Fax |
|
| Email |
chandish008@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shija Hospitals & Research Institute
HealthVillage, Langol, Lamphelpat
Imphal-West, Manipur – 795004
India |
|
|
Primary Sponsor
|
| Name |
Shija Hospitals and Research Institute |
| Address |
Shija Hospitals & Research Institute
HealthVillage, Langol, Lamphelpat
Imphal-West, Manipur – 795004
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrThoudam Chandish Singh |
Shija Hospitals & Research Institute |
Department of Anaesthesia 1st floor,Shija Hospitals ,HealthVillage, Langol, Lamphelpat
Imphal-West, Manipur – 795004
India
Imphal West
MANIPUR |
8414867624
chandish008@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Istitutional Ethics Committee Shija Academy of Health sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hyperbaric Bupivacaine 0.5% |
3 mL (15 mg) administered intrathecally (subarachnoid block) as a single dose before surgery, using the same spinal anesthesia technique as in the intervention group.The total duration of action of this intervention is expected to be approximately 90–150 minutes (1.5 to 2.5 hours), depending on patient factors and surgical conditions. |
| Intervention |
Hyperbaric Ropivacaine 0.75% |
3 mL (22.5 mg) administered intrathecally (subarachnoid block) as a single dose before surgery, using standard spinal anesthesia technique at L3–L4 interspace with a 25G Quincke spinal needle after confirming free flow of CSF.The total duration of action of this intervention is expected to be approximately 60–120 minutes (1 to 2 hours), depending on patient factors and surgical conditions. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age between 18 and 65 years
ASA (American Society of Anesthesiologists) physical status I or II
Scheduled for elective infraumbilical surgeries (e.g., inguinal hernia repair, hydrocelectomy, gynecological procedures, lower limb orthopedic surgeries)
Patients who provide written informed consent
|
|
| ExclusionCriteria |
| Details |
Known hypersensitivity to local anesthetics of the amide group
History of coagulopathy or on anticoagulant therapy
Local infection at the puncture site
History of spinal deformities, previous spinal surgery, or neurological disorders
Pregnant or lactating women
Patients on medications that may interact with local anesthetics
Severe cardiovascular, hepatic, or renal disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of sensory and motor block following spinal anesthesia with hyperbaric bupivacaine versus ropivacaine. |
Baseline (before spinal block)
At regular intraoperative intervals (every 5 minutes for the first 30 minutes, then every 15 minutes until block regression)
At the time of complete recovery from sensory and motor bloc |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of effective analgesia, hemodynamic stability including heart rate & blood pressure, & incidence of adverse effects such as hypotension, bradycardia, nausea, vomiting, shivering, & pruritus. |
From intrathecal injection to twenty-four hours postoperatively, with hemodynamic parameters assessed every five minutes for the first thirty minutes, every ten minutes until the end of surgery, & in the post-anesthesia care unit; adverse effects assessed intraoperatively & up to twenty-four hours postoperatively. |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
30/10/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Spinal anesthesia is widely used for infra-umbilical surgeries due to its rapid onset and reliable effect. Hyperbaric bupivacaine is the standard agent but is associated with prolonged motor block and potential hemodynamic instability. Hyperbaric ropivacaine, being a pure S-enantiomer, offers comparable sensory block with faster motor recovery and greater cardiovascular safety. However, limited data exist in the Indian population. This trial aims to compare hyperbaric bupivacaine and hyperbaric ropivacaine with respect to sensory and motor block characteristics, duration of analgesia, hemodynamic stability, and adverse effects in adult patients undergoing infra-umbilical surgeries |