| CTRI Number |
CTRI/2024/08/071933 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
05/08/2024 |
| 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
|
To compare two spinal anaesthetic drug with additive for lower abdominal surgeries |
|
Scientific Title of Study
|
Comparison of 0.5 percent hyperbaric bupivacaine and 0.5 percent hyperbaric levobupivacaine with buprenorphine as an adjuvant for spinal anesthesia in adults undergoing infraumbilical surgeries – a one year hospital based randomized control trial. |
| 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 Anul R Shinde |
| Designation |
Junior Resident |
| Affiliation |
KLE Dr Prabhakar Kore Hospital and Medical Research Centre |
| Address |
Department of Anaesthesiology (second floor), Jawaharlal Nehru Medical College, Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
9930683629 |
| Fax |
|
| Email |
anul.shinde@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shreedevi Yenni |
| Designation |
Associate Professor |
| Affiliation |
KLE Dr Prabhakar Kore Hospital and Medical Research Centre |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College, Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
9986710478 |
| Fax |
|
| Email |
shreeyenni@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shreedevi Yenni |
| Designation |
Associate Professor |
| Affiliation |
KLE Dr Prabhakar Kore Hospital and Medical Research Centre |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College, Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
9986710478 |
| Fax |
|
| Email |
shreeyenni@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Jawaharlal Nehru Medical College, KLE University, Belagavi (Karnataka) - 590010 |
|
|
Primary Sponsor
|
| Name |
Dr Anul R Shinde |
| Address |
Department of Anaesthesiology (second floor), Jawaharlal Nehru Medical College, Belagavi. |
| Type of Sponsor |
Other [Self ] |
|
|
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 Anul R Shinde |
Dr Prabhakar Kore Hospital & MRC |
Department of Anaesthesiology, Second floor, Jawaharlal Nehru Medical College, KLE University, Belagavi.
Belgaum
KARNATAKA |
9930683629
anul.shinde@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M238||Other internal derangements of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bupivacaine Group |
Patients will be administered 15mg of 0.5% hyperbaric bupivacaine + 60mcg of buprenorphine. (outcome will be seen upto 15 minutes after giving the study drug) |
| Comparator Agent |
Levobupivacaine Group |
Patients will be administered 15mg of 0.5% hyperbaric levobupivacaine + 60mcg of buprenorphine. (outcome will be seen upto 15 minutes after giving the study drug) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-60 years
Either gender
American Society of Anesthesiologists (ASA) grade I and II patients
Patients undergoing infraumbilical surgeries under spinal anesthesia
|
|
| ExclusionCriteria |
| Details |
Patients with American Society of Anesthesiologists (ASA) grade III or more
Patients with allergy to study drug
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of intrathecal buprenorphine as an adjuvant to 0.5% hyperbaric bupivacaine and 0.5% hyperbaric levobupivacaine on hemodynamic parameters (HR, SBP, DBP, MAP, SpO2 ) in adults undergoing infraumbilical surgeries under spinal anesthesia. |
Pre operative, 0 minute, 5 minutes, 15 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| - To evaluate and compare the onset of sensory and motor blockade of intrathecal buprenorphine as an adjuvant to 0.5% hyperbaric bupivacaine and 0.5% hyperbaric levobupivacaine in adults undergoing infraumbilical surgeries under spinal anesthesia. |
0 minute
1 minute
2 minutes
3 minutes
4 minutes
5 minutes |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
26/08/2024 |
| 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 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 study is being undertaken with the aim of comparing intrathecal buprenorphine as an adjuvant to 0.5% hyperbaric bupivacaine and 0.5% hyperbaric levobupivacaine for spinal anesthesia in adults undergoing infraumbilical surgeries. The purpose of this study is to compare the haemodynamic parameters and to compare the onset of sensory and motor block between two drugs. |