| CTRI Number |
CTRI/2023/11/059573 [Registered on: 06/11/2023] Trial Registered Prospectively |
| Last Modified On: |
03/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study To Compare The Block Characteristics Of A Drug Named Ropivacaine 0.75% Heavy And 0.5% Bupivacaine Heavy For Spinal Anaesthesia In Infraumbillical Surgeries |
|
Scientific Title of Study
|
A Comparative Study Of Hyperbaric Ropivacaine 0.75% Vs Hyperbaric Bupivacaine 0.5% For Spinal Anaesthesia In Infraumbillical 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 R Jagadish Raj |
| Designation |
Postgraduate Medical Student |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department on Anaesthesia
room no 3, 3rd floor
tippu sultan, Fort, Krishna Rajendra Rd, Bangalore, Karnataka
Bangalore
KARNATAKA
560002
India |
| Phone |
7353040883 |
| Fax |
|
| Email |
drjagadishraj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinay Marulasiddappa |
| Designation |
Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department on Anaesthesia
room no 666, 3rd floor
tippu sultan, Fort, Krishna Rajendra Rd, Bangalore, Karnataka
Bangalore
KARNATAKA
560002
India |
| Phone |
8073997005 |
| Fax |
|
| Email |
drvinaym@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinay Marulasiddappa |
| Designation |
Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department on Anaesthesia
room no 666, 3rd floor
tippu sultan, Fort, Krishna Rajendra Rd, Bangalore, Karnataka
KARNATAKA
560002
India |
| Phone |
8073997005 |
| Fax |
|
| Email |
drvinaym@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,
Bangalore Medical College and Research Institute |
|
|
Primary Sponsor
|
| Name |
Dr R Jagadish Raj |
| Address |
Fort, Krishna Rajendra Rd, Bengaluru, Karnataka |
| 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 R Jagadish Raj |
Bangalore Medical College |
Department on Anaesthesia, Main ot complex
room no 1-6, 3rd floor
tippu sultan, Fort, Krishna Rajendra Rd, Bangalore, Karnataka
KARNATAKA
Bangalore
KARNATAKA |
7353040883
drjagadishraj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Bangalore Medical College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.5% hyperbaric ropivacaine |
3ml of 0.5% bupivacaine heavy ( 15 mg) given subarachnoid space once with patient in sitting position with a 25G quincke needle at a speed of 0.2ml/second |
| Intervention |
0.75% hyperbaric ropivacaine |
3ml of 0.75% ropivacaine heavy ( 22.5mg) given once in subarachnoid space with patient in sitting position with a 25G quincke needle at a speed of 0.2ml/second |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
2. Patient willing to give informed consent
3. ASA grade 1 and 2
4. Patients undergoing infraumbilical surgeries under spinal anaesthesia.
|
|
| ExclusionCriteria |
| Details |
1. Patients refusing to give informed consent
2. Patients undergoing emergency surgeries
3. Patients with history of allergy to the study drugs
4. Pregnant women
5. Patients ASA grade 3,4,5
6. Patients under 18 years and over 60 years of age.
7. Infection at the site of injection
8. Sepsis
9. Spinal deformities
10. Severe hypovolemia
11. Coagulopathies
12. Raised intracranial tension
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effects of hyperbaric ropivacaine 0.75% with hyperbaric bupivacaine 0.5% on onset, duration, time to maximum sensory and motor block.maximum level of sensory block, time to 2 segment regression of sensory block |
baseline, every minute upto 10 minutes, every 10 minutes upto end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effects of the 2 drugs on heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, saturation of oxygen & the incidence of adverse effects if any. |
baseline, every minute upto 10 minutes, every 10 minutes upto end of surgery |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
17/11/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Spinal anaesthesia or subarachnoid block is a widely used regional
anaesthetic technique in a variety of infraumbillical, perineal and lower limb
surgeries. It is achieved by injection of local anaesthetic into subarachnoid
space mainly in the lumbar area.
It
results in sympathetic, sensory and motor blockade depending the concentration,
volume and baricity of the drug injected. Ropivacaine is an amide local anaesthetic which is produced as a pure S
enantiomer. The S enantiomers are less neurotoxic and cardiotoxic compared to R
enantiomers and racemic mixture forms of amide pipecoloxylidide local
anaesthetics. Bupivacaine is considered the gold standard long
acting local anaesthetic for most regional anaesthetic procedures such as
subarachnoid block.Ropivacaine compared to bupivacaine has a better safety profile but produces
a lower grade of motor block and has a shorter duration of action.Studies have been done comparing the clinical
effectiveness of 0.75% plain ropivacaine with 0.5% heavy bupivacaine which
showed a similar quality of block with late onset and shorter duration of
sensory and motor blockade in 0.75% plain ropivacaine. This study aims to
compare the block characteristics of 0.75% heavy ropivacaine with 0.5% heavy
bupivacaine in infraumbillical surgeries, |