| CTRI Number |
CTRI/2024/03/064555 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
19/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ropivacaine heavy 0.75% vs Bupivacaine heavy 0.5% in infraumbilical surgeries for duration of analgesia |
|
Scientific Title of Study
|
A comparative study of effect of intrathecal hyperbaric Ropivacaine 0.75% vs hyperbaric Bupivacaine 0.5% for postoperative analgesia in Infraumblical surgeries |
| 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 VEENA PATODI |
| Designation |
senior professor |
| Affiliation |
jawahar lal nehru medical college |
| Address |
Department of Anaesthesiology new OT 1st floor
jawahar lal nehru medical college and hospitals ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414008276 |
| Fax |
|
| Email |
veenapatodi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VEENA PATODI |
| Designation |
senior professor |
| Affiliation |
jawahar lal nehru medical college |
| Address |
Department of Anaesthesiology new OT 1st floor
jawahar lal nehru medical college and hospitals ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414008276 |
| Fax |
|
| Email |
veenapatodi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr VEENA PATODI |
| Designation |
senior professor |
| Affiliation |
jawahar lal nehru medical college |
| Address |
Department of Anaesthesiology new OT 1st floor
jawahar lal nehru medical college and hospitals ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414008276 |
| Fax |
|
| Email |
veenapatodi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Depatment of Anaesthesiology new OT 1st floor jawahar lal nehru medical college and hospitals Kalabagh Ajmer Rajasthan 305001 |
|
|
Primary Sponsor
|
| Name |
Jawahar lal nehru medical college |
| Address |
Kalabagh Ajmer Rajasthan 305001 |
| Type of Sponsor |
Government 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 |
| Dr Asfaq Ahmed |
jawahar lal nehru medical college |
Department of Anaesthesiology New OT 1st floor Jawahar Lal Medical college Kalabagh Ajmer
Ajmer
RAJASTHAN |
8233730272
drasfaqahmed@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Jawahar Lal Nehru Medical College and Hospitals Ajmer |
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 |
inj.Bupivacaine 0.5% |
with due approval of institutional ethical committee a double blinded randomized study will be conducted. 50 participatnts who will be undergoing infraumbilical surgeries under spinal anaesthesia will be grouped into Group B and will be recieving Hyperbaric Bupivacaine 0.5% 3ml intrathecally under all aseptic precautions. a written informed consent will be taken prior to procedure. participants will be followed for duration of analgesia in post operative period till patients complains of pain of demands for rescue analgesia for fisrt time. |
| Intervention |
inj.Ropivacaine |
with due approval of institutional ethical committee a double blinded randomized study will be conducted. 50 participatnts who will be undergoing infraumbilical surgeries under spinal anaesthesia will be grouped into Group R and will be recieving Hyperbaric Ropivacaine 0.75% 3ml intrathecally under all aseptic precautions. a written informed consent will be taken prior to procedure. participants will be followed for duration of analgesia in post operative period till patients complains of pain of demands for rescue analgesia for fisrt time. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Body weight 40 to 80 kg
2. ASA class I and II
3. patients undergoing infraumblical surgeries |
|
| ExclusionCriteria |
| Details |
1.Patients refusal and uncooperative patients
2.Hypersensitivity to study drugs
3. local site infection
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| duration of analgesia |
pain will be assessed using Visual Analogue Score in immediate postoperative period follwoed by hourly interval till 24 hrs post opertively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. onset and duration of sensory block
2.onset and duration of motor block
3. hemodynamic changes and adverse effects |
1.using hypodermic needle immediately after spinal, every 2 minutes till 10minut, every 5minute till 60minute then every hour till 6 hour in post operative period then every 6hour till 24 hour.
2.Assessed using Bromage score immediately after spinal, every 2 minutes till 10minut, every 5minute till 60minute then every hour till 6 hour in post operative period then every 6hour till 24 hour. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
07/03/2025 |
| 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="1"
Months="0"
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
|
With due approval of institutional ethical committee a double blinded randomized study will be conducted. 100 participatnts who will be undergoing infraumbilical surgeries under spinal anaesthesia. 50 participants will be grouped into Group R and will be recieving Hyperbaric Ropivacaine 0.75% 3ml intrathecally under all aseptic precautions. 50 participants will be grouped into Group B Will be recieving hyperbaric Bupivacaine 0.5% 3ml intrathecally . A written informed consent will be taken prior to procedure.Participants will be monitored for duration of analgesia as primary outcome and onset and duration of sensory block, motor block and hemodynamic adverse effects as secondary outcome in intraopertive and post operative period till patients complains of pain or demands for rescue analgesia for fisrt time. Data will be collected and analyzed using standard test and p value of less than 0.05 will be considered significant. |