| CTRI Number |
CTRI/2025/03/082044 [Registered on: 10/03/2025] Trial Registered Prospectively |
| Last Modified On: |
09/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Two Doses of Spinal Anesthesia on Affected Side of Inguinal Hernia Surgery |
|
Scientific Title of Study
|
Comparative Evaluation of Two Different Doses of 0.5 percent Hyperbaric Bupivacaine for Unilateral Spinal Anesthesia During Elective Inguinal Hernia Surgery |
| 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 Susmita Sarangi |
| Designation |
Grade-1 Specialist |
| Affiliation |
Deen Dayal Upadhyay Hospital |
| Address |
Department of Anaesthesiology, Deen Dayal Upadhyay Hospital, Hari Nagar, New Delhi
West
DELHI
110064
India |
| Phone |
9718990113 |
| Fax |
|
| Email |
drpsarangi@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Susmita Sarangi |
| Designation |
Grade-1 Specialist |
| Affiliation |
Deen Dayal Upadhyay Hospital |
| Address |
Department of Anaesthesiology, Deen Dayal Upadhyay Hospital, Hari Nagar, New Delhi
DELHI
110064
India |
| Phone |
9718990113 |
| Fax |
|
| Email |
drpsarangi@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Susmita Sarangi |
| Designation |
Grade-1 Specialist |
| Affiliation |
Deen Dayal Upadhyay Hospital |
| Address |
Department of Anaesthesiology, Deen Dayal Upadhyay Hospital, Hari Nagar, New Delhi
DELHI
110064
India |
| Phone |
9718990113 |
| Fax |
|
| Email |
drpsarangi@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Deen Dayal Upadhyay Hospital, Hari Nagar, New Delhi, 110064 |
|
|
Primary Sponsor
|
| Name |
Deen Dayal Upadhyay Hospital |
| Address |
Hari Nagar, New Delhi, 110064 |
| 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 |
| Dr Jumna Y |
Deen Dayal Upadhyay Hospital |
Main Operation Theatre, Second Floor, Department of Anaesthesiology, Deen Dayal Upadhyay Hospital,Hari Nagar, New Delhi, 110064
West
DELHI |
8943437672
jumna94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituional Ethics Committee - Deen Dayal Upadhyay Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparative evaluation of two different doses of 0.5% hyperbaric bupivacaine for unilateral spinal anaesthesia during elective inguinal hernia surgery |
To compare the sensory blockade on the operative and non-operative side with 7.5 mg of 0.5% Hyperbaric Bupivacaine and 10 mg of 0.5% Hyperbaric Bupivacaine in unilateral spinal anaesthesia during elective inguinal hernia surgery |
| Comparator Agent |
Comparing 7.5 mg and 10 mg of 0.5% Hyperbaric Bupivacaine |
The study aims to find which of the two doses among 7.5 mg and 10 mg of 0.5% Hyperbaric Bupivacaine used for inguinal hernia surgery is effective in providing adequate unilateral spinal anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Physical Status Grade I & II, Patient to be operated for uncomplicated direct or indirect inguinal hernia under spinal anaesthesia. BMI between 18 and 25. |
|
| ExclusionCriteria |
| Details |
Patient with history of allergy to drugs, Abnormality or infection in lumbar and groin region, Patient having peripheral neuropathy and coagulation disorders. |
|
|
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 |
| To assess the level of sensory and motor block in operative side |
0, 5, 10, 20, 30 minute, and at the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the level of sensory and motor block in both operative and nonoperative side |
0, 5, 10, 20, 30 minute, and at the end of surgery |
| Non-invasive haemodynamic variables (Heart Rate, SBP, DBP, MAP) |
0, 5, 10, 20, 30 minute, and at the end of surgery |
| Time from the end of spinal injection to achieve sensory block upto T10 & motor block score 3 using modified bromage scale in both groups |
Recorded in minutes based on the time taken |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 2 |
|
Date of First Enrollment (India)
|
20/03/2025 |
| 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="3"
Days="10" |
|
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
|
This is a prospective and interventional randomized comparative study to compare sensory blockade on the operative side with two different doses of 0.5% hyperbaric bupivacaine for unilateral spinal anaesthesia during elective inguinal hernia surgery. Here the patient will be allocated to 2 groups by block randomization with sealed envelope system. One group will be given 7.5mg of 0.5% hyperbaric bupivacaine and the other group will be given 10mg of 0.5% hyperbaric bupivacaine. Level of sensory and motor block will be assessed in both operative and non operative side and non invasive haemodynamic variables (HR, SBP, DBP, MAP) will be observed from standard monitors intra operatively at 0 min, 5 min, 10 min, 20 min, 30 min, and at the end of surgery in both groups will be assessed. Time from end of spinal injection to achieve sensory block up to T10 and motor block score 3 by using modified bromage scale in both groups will be assessed. |