CTRI Number |
CTRI/2023/02/049446 [Registered on: 06/02/2023] Trial Registered Prospectively |
Last Modified On: |
04/02/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
comparative study to identify effect levobupivacaine vs bupivacaine in spinal anesthesia for below umbilical surgeries |
Scientific Title of Study
|
A comparative study of anesthetic efficacy of 0.5 % Hyperbaric levobupivacaine Vs 0.5 % Hyperbaric bupivacaine for intrathecal anesthesia in below umbilical surgeries- A Prospective Randomized Study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DR SENTHIL KUMARB |
Designation |
FIRST YEAR POSTGRADUATE |
Affiliation |
sri manakula vinayagar medical college and hospital |
Address |
NO-109,DEPARTMENT OF ANESTHESIA, SRI MANAKULA VINAYAGAR MEDICAL COLLEGE,
MADAGADIPET, PONDICHERRY
Pondicherry PONDICHERRY 605107 India |
Phone |
9791555127 |
Fax |
|
Email |
senthil1976.sk@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DRSUNEETH P LAZARUS |
Designation |
HOD ANESTHESIA |
Affiliation |
SRI MANAKULA VINAYAGAR MEDICAL COLLEGE AND HOSPITAL |
Address |
NO-109,DEPARTMENT OF ANESTHESIA, SRI MANAKULA VINAYAGAR MEDICAL COLLEGE,
MADAGADIPET, PONDICHERRY
Pondicherry PONDICHERRY 605107 India |
Phone |
9894332543 |
Fax |
|
Email |
lazarus.suneeth@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DRSUNEETH P LAZARUS |
Designation |
HOD ANESTHESIA |
Affiliation |
SRI MANAKULA VINAYAGAR MEDICAL COLLEGE AND HOSPITAL |
Address |
NO-109,DEPARTMENT OF ANESTHESIA, SRI MANAKULA VINAYAGAR MEDICAL COLLEGE,
MADAGADIPET, PONDICHERRY
Pondicherry PONDICHERRY 605107 India |
Phone |
9894332543 |
Fax |
|
Email |
lazarus.suneeth@gmail.com |
|
Source of Monetary or Material Support
|
sri manakula vinayagar medical college and hospital |
|
Primary Sponsor
|
Name |
sri manakula vinayagar medical college and hospital |
Address |
NO-109 DEPARTMENT OF ANESTHESIA
SRI MANAKULA VINAYAGAR MEDICAL COLLEGE AND HOSPITAL
MADAGADIPET PONDICHERRY |
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 SENTHIL KUMAR B |
SRI MANAKULA VINAYAGR MEDICAL COLLEGE AND HOSPITAL |
NO-109
DEPARTMENT OF ANESTHESIA Pondicherry PONDICHERRY |
9791555127
senthil1976.sk@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
SMVMCH-EC |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
to compare the effect of levobupivacaine to standared bupivacaine dose administered intrathecally |
3ml of 0.5% hyperbaric bupivacaine total of 15mg will be given once in subarachnoid space |
Intervention |
to study the anesthetic efficacy of levobupivacaine when given intrathecally for spinal anesthesia |
3 ml of 0.5% hyperbaric levobupivacaine total of 15mg will be given once in subarachnoid space |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.Patients scheduled to undergo elective infra umbilical surgeries under spinal anesthesia for next one year from the date of clearance from Ethical committee.
2. Patients of ASA physical status 1 & 2.
3. Patients of either sex.
4. Age >18 years or < 60 years.
5. Patients with height more than 150 cm
|
|
ExclusionCriteria |
Details |
1. Body Mass Index >30.
2. Patients with local site infection, allergy to the drugs that are to be tested
or any othercontraindications for spinal anesthesia.
3. Patients who cannot lie down/ non-co-operative/ psychiatric illness.
4. Alcoholics.
5. Pregnant / Lactating women.
6. Patient having failed spinal, transformed into general anesthesia will be excluded from
study.
7. Patients refusal for participation in the study.
8. Patients with height less than 150 cm.
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To compare the sub-arachnoid block characteristics between 0.5% hyperbaric Levobupivacaine and 0.5% hyperbaric bupivacaine in below umbilical surgeries. |
to assess the sensory blockade every 2 mins till 20mins
to assess the motor blockade every 5mins till maximum level achieved |
|
Secondary Outcome
|
Outcome |
TimePoints |
to assess difference in hemodynamic parameter between both the groups
to assess the adverse reaction between two groups |
10mins before spinal then at 5 mins every 10 mins for the first half an hour and at 1 hr 2 hrs |
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
08/02/2023 |
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="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
not yet published |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
This study is a prospective double-blinded randomized trial comparing
the anesthetic
efficacy of 0.5 % Hyperbaric levobupivacaine and 0.5 % Hyperbaric bupivacaine
for intrathecal anesthesia in below umbilical surgeries. The primary outcome is
to compare the sub-arachnoid block characteristics
between 0.5% hyperbaric Levobupivacaine and 0.5% hyperbaric bupivacaine in
below umbilical surgeries. Sensory
blockade will be assessed after the injection every 2 minutes till and motor blockade is assessed by
modified bromage scale every 5 min until the maximum motor block is achieved having a stable sensory
level for the next 20 mins. The secondary objective is to assess and compare hemodynamic parameters between the
group, hemodynamic
parameters – systolic blood pressure, diastolic blood pressure, mean arterial
pressure (MAP), heart rate and oxygen saturation are to be recorded 10 minutes prior to the
procedure and then at 5 mins, every 10 mins for the first half an hour and at 1
hr., 2 hrs. To assess and compare adverse effects between the group (nausea & Vomiting, adverse drug reaction, arrhythmia,
respiratory depression). The time taken for the first rescue analgesia in the immediate
post-operative period will be noted in both groups. Intravenous PARACETAMOL at
15 mg/kg will be used as the Rescue analgesia. Any adverse drug reactions to
the drugs will be reported to the ethics committee within 24 hours of the
occurrence of the event. |