| CTRI Number |
CTRI/2025/09/095213 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
21/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing three medicines used for spinal anaesthesia and their effects on blood pressure and nerve block when lying down is delayed by one minute |
|
Scientific Title of Study
|
Block characteristics and hemodynamics changes in one minute delay before transitioning patient to supine, comparison of three different local anaesthetics in spinal anaesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pachigolla Sri Sahiti |
| Designation |
Junior Resident |
| Affiliation |
KS Hegde Medical Academy |
| Address |
Department of Anaesthesiology and Critical care, KS Hegde Medical Academy, P.O.Nithyanadagar , Mangalore, Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9398083902 |
| Fax |
|
| Email |
sahitipachigolla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Murali Shankar Bhat A |
| Designation |
Associate Professor |
| Affiliation |
KS Hegde Medical Academy |
| Address |
Department of Anaesthesiology and Critical care, KS Hegde Medical Academy, P.O.Nithyanadagar , Mangalore, Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8884537753 |
| Fax |
|
| Email |
muralishankarbhat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pachigolla Sri Sahiti |
| Designation |
Junior Resident |
| Affiliation |
KS Hegde Medical Academy |
| Address |
Department of Anaesthesiology and Critical care, KS Hegde Medical Academy, P.O.Nithyanadagar , Mangalore, Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9398083902 |
| Fax |
|
| Email |
sahitipachigolla@gmail.com |
|
|
Source of Monetary or Material Support
|
| K S Hegde Medical Academy, Mangalore, Dakshin Kannada, Karnataka, pin code 575018 |
|
|
Primary Sponsor
|
| Name |
K S Hegde Medical Academy |
| Address |
Department of Anaesthesiology and Critical Care,K S Hegde Medical Academy, P.O.Nithyandagar, Mangalore, Karnatka-575018 |
| Type of Sponsor |
Private 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 |
| DrPachigolla Sri Sahiti |
K S HEGDE MEDICAL ACADEMY |
Department of Anaesthseiology and Critical Care,K S Hegde Medical Academy, P.O.Nithyanadagar, Mangalore,Karnataka
Dakshina Kannada
KARNATAKA |
9398083902
sahitipachigolla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KS HEGDE MEDICAL ACADEMY |
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 |
| Intervention |
0.5% Buprenorphine |
3 ml of drug is given in patient undergoing infraumbilical surgeries intrathecally in sitting position and after one minute patient is made to lie supine |
| Comparator Agent |
0.5% Levobupivacaine |
3 ml of drug is given in patient undergoing infraumbilical surgery intrathecally in sitting position and after one minute patient is made to lie supine |
| Comparator Agent |
0.75% Ropivacaine |
3ml of drug is given in patient undergoing infraumbilical surgery intrathecally in sitting position and after one minute patient is made to lie supine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who come under ASA 1 and ASA 2
Patients with height between 150-180cm
Patients undergoing infraumbilical surgeries under subarachnoid block |
|
| ExclusionCriteria |
| Details |
Patients who refuse to participate in trail
Patient who cannot comprehend, uncooperative patient
Pregnant patients
Patients who cannot sit
Patients with any neurological deficits |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sensory and Motor block characteristics in terms of onset, maximum level acheived and duration of block following administration of 0.5% Bupivacaine or 0.5% Levobupivacaine or 0.75% Ropivacaine intrathecally |
Sensory and Motor block level at baseline , 1 minute, 2 minutes,3 minutes, 4 minutes, 5 minutes, 6 minutes,7 minutes, 8 minutes , 9 minutes, 10 minutes,12 minutes,14 minutes,16 minutes,18 minutes, 20 minutes after intrathecal administration of drug |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamics changes such as changes in heart rate, blood pressure, blood oxygen saturation & complications such as requiring supplemental dose of analgesia, nausea & vomiting, inadequate spinal anaesthesia requiring either repeating intrathecal drug or converting to general anaesthesia |
At time of drug given, 2 minutes,4 minutes,6 minutes,8 minutes, 10 minutes, 12 minutes,14 minutes, 16 minutes, 18 minutes, 20 minutes, 25 minutes,30 minutes,35 minutes, 40 minutes, 45 minutes,50 minutes,55 minutes,60 minutes after drug is given intrathecally |
|
|
Target Sample Size
|
Total Sample Size="153"
Sample Size from India="153"
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
|
N/A |
|
Date of First Enrollment (India)
|
03/10/2025 |
| 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="0"
Months="8"
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
|
Spinal anaesthesia is commonly used for lower limb and lower abdominal surgeries, but immediate supine positioning may cause higher block spread and hemodynamic instability. This study compares 0.5% hyperbaric bupivacaine, 0.5% hyperbaric levobupivacaine, 0.75% hyperbaric ropivacaine when patients are kept sitting for one minute before lying supine. The primary outcomes are sensory and motor block characteristics and secondary outcomes include hemodynamic changes and complications. |