| CTRI Number |
CTRI/2024/07/071082 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to compare the effectiveness of heavy levobupivacaine and heavy Bupivacaine in spinal anaesthesia for lower abdominal and lower limb surgeries |
|
Scientific Title of Study
|
A Randomised controlled study
comparing Hyperbaric Levobupivacaine
0.5 percent with Hyperbaric Bupivacaine 0.5 percent for its efficacy in Spinal Anaesthesia for lower abdominal and lower limb 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 |
Noopur Choudhary |
| Designation |
Postgraduate |
| Affiliation |
D Y Patil Hospital |
| Address |
A block Second floor Department of Anaesthesia
D Y Patil Hospital
Ayyappa temple Road sector 5, Nerul Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
8462946686 |
| Fax |
|
| Email |
noopur03.nc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anuradha Malliwal |
| Designation |
Professor |
| Affiliation |
D Y Patil Hospital |
| Address |
A block Second floor Department of Anaesthesia
D Y Patil Hospital
Ayyappa temple Road sector 5, Nerul Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9920318482 |
| Fax |
|
| Email |
anumalliwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anuradha Malliwal |
| Designation |
Professor |
| Affiliation |
D Y Patil Hospital |
| Address |
A block Second floor Department of Anaesthesia
D Y Patil Hospital
Ayyappa temple Road sector 5, Nerul Navi Mumbai
MAHARASHTRA
400706
India |
| Phone |
9920318482 |
| Fax |
|
| Email |
anumalliwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| D Y Patil Hospital, Sector 7, Nerul , Navi Mumbai, Maharashtra , India 400706 |
|
|
Primary Sponsor
|
| Name |
D Y Patil Hospital |
| Address |
A block Second floor Department of Anaesthesia
D Y Patil Hospital
Ayyappa temple Road sector 5, Nerul Navi Mumbai, Maharashtra, India 400706 |
| Type of Sponsor |
Private 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 Noopur Choudhary |
D Y Patil Hospital |
A block Second floor Department of Anaesthesia
D Y Patil Hospital
Ayyappa temple Road sector 5, Nerul Navi Mumbai
Thane
MAHARASHTRA |
8462946686
noopur03.nc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee for Biomedical and Health research (IECBH) of Dr D Y Patil Medical College & Hospital, |
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 |
Hyperbaric Bupivacaine 0.5% |
Concentration : 0.5%
Dosage : 3.2cc
Route : Intrathecal
Duration : 3hours |
| Intervention |
Hyperbaric Levobupivacaine 0.5%
|
concentration : 0.5%
Dosage : 3.2cc
Route : Intrathecal
Duration : 3hours
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient undergoing abdominal and lower limb surgeries under spinal anaesthesia
2.ASA 1 and 2
|
|
| ExclusionCriteria |
| Details |
1.Known hypersensitivity to amide local anaesthetics
2.Contraindications for spinal anaesthesia
3.Bleeding disorders or on anti-coagulant therapy , documented neuromuscular therapy
4.Any infection at the injection site
5.Any spinal deformity
6.Pregnant patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the clinical efficacy of hyperbaric bupivacaine 0.5% and hyperbaric levobupivacaine 0.5% in spinal anaesthesia based on onset of motor block |
every 2 mins for first 20mins followed by every 10mins till 60mins then every 30mins till 180mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time taken for complete motor blockade , onset of sensory blockade, duration of sensory and motor blockade and hemodynamic parameters |
every 2 mins for first 20mins followed by every 10mins till 60mins then every 30mins till 180mins |
|
|
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)
|
05/08/2024 |
| 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 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [noopur03.nc@gmail.com].
- For how long will this data be available start date provided 01-07-2025 and end date provided 15-11-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
60 patients of ASA class I or class II of either sex,
between 18-65 years undergoing elective lower
abdominal and lower limb surgeries and who gave
written informed consent for the study, will be recruited
and randomized .After clinical assessment and routine
investigations , they will randomly be allocated into two
groups containing 30 patients each. Group A will receive spinal anaesthesia using 3.2 ml of
0.5% bupivacaine heavy. Group B will receive spinal anaesthesia using 3.2 ml of
0.5% Levobupivacaine heavy. After taking the patient inside the operation theatre, the
monitors will be placed and continuous monitoring will be done. After the injection of the spinal medication, heart rate
and arterial blood pressure will be measured. Arterial
pressure and heart rate will be recorded at 2min interval
upto 20min and 10min intervals thereafter until 60 mins followed by 30mins till 180mins. The assessments of sensory block done by pinprick test and
Results of the pin rick test were determined bilaterally at
midclavicular level by needle. Motor block in the lower limb was assessed by using
a modified Bromage scale (0 no paralysis, 1 unable to raise
extended leg, 2 unable to flex knee, 3 unable to flex ankle). These assessments will be performed immediately after the
assessments of sensory block until the return of normal
motor function.
The measurement will also include peak block height, motor
and sensory blockade, duration and side effects. |