| CTRI Number |
CTRI/2023/09/057269 [Registered on: 06/09/2023] Trial Registered Prospectively |
| Last Modified On: |
03/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to compare ropivacaine and bupivacaine for lower abdomen and lower limb surgeries under spinal anaesthesia. |
|
Scientific Title of Study
|
A comparative study of 0.75% hyperbaric ropivacaine versus 0.5% hyperbaric bupivacaine for lower abdomen and lowerlimb surgeries under 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 |
Dr Kavya Kanjikkal |
| Designation |
PG resident |
| Affiliation |
Gajra Raja Medical College |
| Address |
Department of Anaesthesiology
Gajra Raja Medical College
Gwalior
474009
Madhya Pradesh
India
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
9487918731 |
| Fax |
|
| Email |
kavyakanjikkal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preeti Goyal |
| Designation |
Professor |
| Affiliation |
Gajra Raja Medical College |
| Address |
Department of Anaesthesiology
Gajra Raja Medical College
Gwalior
Madhyapradesh
474009
India
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
9424455330 |
| Fax |
|
| Email |
drpreetiravigoyal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavya Kanjikkal |
| Designation |
PG resident |
| Affiliation |
Gajra Raja Medical College |
| Address |
Department of Anaesthesiology
Gajra Raja Medical College
Gwalior
474009
Madhya Pradesh
India
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
9487918731 |
| Fax |
|
| Email |
kavyakanjikkal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gajra Raja Medical College GRMC Gwalior Madhya Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr Kavya Kanjikkal |
| Address |
Department of Anaesthesiology
GRMC
Gwalior
Madhya Pradesh
474009
India |
| 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 Kavya Kanjikkal |
Gajra Raja Medical College and Jayarogya Hospital |
Department of Anaesthesiology
GRMC
Gwalior
Madhya Pradesh
474009
India1
Gwalior
MADHYA PRADESH |
9487918731
kavyakanjikkal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Gajra Raja Medical College Gwalior |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, (2) ICD-10 Condition: N813||Complete uterovaginal prolapse, (3) ICD-10 Condition: N430||Encysted hydrocele, (4) ICD-10 Condition: S820||Fracture of patella, (5) ICD-10 Condition: S821||Fracture of upper end of tibia, (6) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
BUPIVACAINE |
0.5% hyperbaric bupivacaine 3ml (15 mg) in lower abdomen and lower limb surgeries under spinal anaesthesia in a study conducting in 6 months |
| Intervention |
ROPIVACAINE |
0.75% hyperbaric Ropivacaine 3ml (22.5mg)in lower abdomen and lower limb surgeries under spinal anaesthesia in a study conducting in 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing lower abdomen surgeries giving consent to participate in study. Age between 18 to 65 years. Body weight between 45 to 70 kg. ASA grade I and II |
|
| ExclusionCriteria |
| Details |
Patients refusal
ASA grade III and IV
Patients with severe respiratory, cardiovascular, renal diseases, obesity
Infection
Coagulopathy
Spinal deformity
Allergic to local anaesthetic drugs
History of seizure and neurological deficit
Age below 18 years and above 65 years
weight below 45kg and above 70 kg
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Expected more hemodynamic stability in 0.75% Ropivacaine compared to bupivacaine during spinal anaesthesia intraoperatively & post operatively |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Expected faster recovery early mobilization & micturition in Ropivacaine compared to bupivacaine |
24 hours |
| Expected better cardiac stability in 0.75% Ropivacaine than Bupivacaine |
24 hours |
| expected early sensory & motor block in 0.75 % Ropivacaine than Bupivacaine |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
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)
|
13/09/2023 |
| 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="6"
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
|
This is a prospective comparative study of 0.75% Ropivacaine and 0.5 % Bupivacaine in lower abdomen and lower limb surgeries under spinal anaesthesia. in this study we are comparing hemodynamic stability, sensory and motor blockade, cardiac stability, faster recovery, early mobilization and micturition |