| CTRI Number |
CTRI/2022/10/046588 [Registered on: 18/10/2022] Trial Registered Prospectively |
| Last Modified On: |
18/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing mixture of local anaesthetic 0.5 % bupivacaine with fentanyl versus mixture of local anaesthetic ropivacaine 0.75% with fentanyl during operations in lower limb and lower abdomen |
|
Scientific Title of Study
|
Comparison of intrathecal 0.5% hyperbaric bupivacaine plus fentanyl with 0.75% hyperbaric ropivacaine plus fentanyl in lower limb and lower abdominal surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jeyakumaar S S G |
| Designation |
Postgraduate Student |
| Affiliation |
ESIC Medical College and PGIMSR KK Nagar |
| Address |
Department of Anaesthesiology Modular Operation Theatre
First floor B- Block
ESIC MC and PGIMSR
KK Nagar
Chennai Ashok pillar road
KK Nagar
Chennai 600 078 Chennai TAMIL NADU 600078 India |
| Phone |
9962128798 |
| Fax |
|
| Email |
samgjeyakumaar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Radhika K |
| Designation |
Professor |
| Affiliation |
ESIC Medical College and PGIMSR KK Nagar |
| Address |
Department of Anaesthesiology
First floor B-Block
ESIC Medical College and PGIMSR
KK Nagar
Chennai Ashok pillar road
KK Nagar
Chennai 600 078 Chennai TAMIL NADU 600078 India |
| Phone |
9840170887 |
| Fax |
|
| Email |
radhikamurali0095@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Radhika K |
| Designation |
Professor |
| Affiliation |
ESIC Medical College and PGIMSR KK Nagar |
| Address |
Department of Anaesthesiology
First floor B-Block
ESIC Medical College and PGIMSR
KK Nagar
Chennai Ashok pillar road
KK Nagar
Chennai 600 078 Chennai TAMIL NADU 600078 India |
| Phone |
9840170887 |
| Fax |
|
| Email |
radhikamurali0095@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC Medical college and PGIMSR KK Nagar Chennai 600078 |
|
|
Primary Sponsor
|
| Name |
ESIC Medical College and PGIMSR KK Nagar |
| Address |
ESIC Medical College and PGIMSR
KK Nagar
Chennai |
| Type of Sponsor |
Government medical college |
|
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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 Jeyakumaar S S G |
ESIC Medical College and PGIMSR KK Nagar Chennai |
Department of Anaesthesiology Modular Operation Theatre Chennai TAMIL NADU |
9962128798
samgjeyakumaar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intrathecal 0.5 % Hyperbaric Bupivacaine plus Fentanyl |
Dose: 3ml of Bupivacaine 5mg/ml containing dextrose 80mg/ml with fentanyl 25 mcg ,
Frequency: once,
Route: Intrathecal,
Duration of intervention: 3-4 hours |
| Intervention |
Intrathecal 0.75% hyperbaric Ropivacaine plus Fentanyl |
Dose:3 ml of ropivacaine 7.5 mg/ml containing dextrose 80 mg/ml with fentanyl 25 mcg,
Frequency:once,
Route:Intrathecal,
Duration of intervention :3-4 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient with written informed consent
2 ASA physical status of I and II
3 Patient Posted for lower limb and lower abdominal surgeries
4 Age groups 18- 60 years
|
|
| ExclusionCriteria |
| Details |
1 Patient refusal
2 Known allergy to local anaesthetics
3 Gross spinal deformities
4 Pregnancy and Lactating females
5 Contraindications to regional anaesthesia (bleeding diathesis, use of any anti-coagulants, infection at the site of injection)
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of the duration of motor block between the two drugs |
At 2 hours, 3 hours,4 hours,5 hours,6 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to onset of sensory block |
Every 1 min |
| Duration of sensory block |
Every 15 min |
| Time of motor block |
Every 15 min |
| Hemodynamic parameters |
Every 15min |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
27/10/2022 |
| 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="3" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet using this preparation |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Bupivacaine, is an amino-amide compound, was synthesized and introduced into the clinical practice in 1963 and proved to be a very effective long-acting local anaesthetic agent. In 1979, Albright drew attention to the dangers of the longer acting local anaesthetic agents, bupivacaine and etidocaine, in case they gained accidental intravascular access, resulting in re-entrant arrhythmias and cardiac depression, sometimes culminating in cardiac arrest. These shortcomings, of this otherwise novel local anaesthetic, resulted in the development of a newer anaesthetic agent ropivacaine. Ropivacaine and levobupivacaine a new amino-amide local anaesthetic agents, are similar in chemical structure to bupivacaine. Extensive clinical data has shown that ropivacaine is effective and produces hemodynamic stability for regional anaesthetic techniques such as epidural and brachial plexus block. Adjutants like opioids have shown to improve the analgesic duration of post spinal anaesthesia because of their motor sparing property thereby improving the quality and success of anaesthesia. Fentanyl is the most common opioid which is extensively used as an adjuvant to hyperbaric bupivacaine for enhancement of analgesia without increasing the depth of motor and sympathetic block. Hyperbaric ropivacaine with fentanyl has been little studied in intrathecal anaesthesia However, this hyperbaric ropivacaine were isobaric preparations. Due to that the spread of drugs could not be controlled by adjusting the positions. Currently ropivacaine has been introduced as a hyperbaric ropivacaine. Studies comparing hyperbaric ropivacaine with other drugs are very few
Hyperbaric Ropivacaine molecule drug was launched by Neon laboratories first in india followed by other countries on 12.11.2021. No other manufactures available till now for this drug. So, the drug which was used by the previous studies was not hyperbaric ropivacaine. They have used isobaric ropivacaine and mixed with dextrose which is not a original drug molecule used by us.
This hyperbaric ropivacaine molecule which we have used in the original molecule by the manufacture which is approved by DGCI on 13.08.2021.
Only one or two studies carried out in Indian Population they rest or done in western countries. The results from this study will be more valid and relevant to practising anaesthesiologists who will have access to this DGCI approved Hyperbaric Ropivacaine. This can be compared with the previous studies to see if the results are same or different. . Hence this study is conceptualized to compare the effects of block characterises such as duration of action and hemodynamic stability of hyperbaric ropivacaine plus fentanyl in spinal anaesthesia and to compare it with hyperbaric bupivacaine plus fentanyl in lower limb and lower abdominal surgeries.
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