CTRI Number |
CTRI/2018/04/013184 [Registered on: 11/04/2018] Trial Registered Prospectively |
Last Modified On: |
11/04/2018 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
injection of anesthetic medicine in fraction versus in single bolus for lower limb and lower abdominal surgeries |
Scientific Title of Study
|
Comparison of efficacy of fractionated versus single bolus dose of spinal anaesthesia with 0.5% heavy bupivacaine for lower abdominal and lower limb surgeries: A prospective randomised controlled trial |
Trial Acronym |
FSA |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Shilp Bhimasen Joshi |
Designation |
Assistant Professor |
Affiliation |
St. Johns Medical College |
Address |
St Johns Medical College
Kormangala
Bangalore St Johns Medical College
Kormangala
Bangalore Bangalore KARNATAKA 560034 India |
Phone |
09901405136 |
Fax |
|
Email |
drshilpa.josh@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Shilp Bhimasen Joshi |
Designation |
Assistant Professor |
Affiliation |
St. Johns Medical College Hospital |
Address |
St Johns Medical College Hospital
Kormangala
Bangalore 2nd floor , OT complex,
St Johns Medical College Hospital
Kormangala
Bangalore Bangalore KARNATAKA 560034 India |
Phone |
09901405136 |
Fax |
|
Email |
drshilpa.josh@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Manjuladevi |
Designation |
Associate Professor |
Affiliation |
St. Johns Medical College |
Address |
St Johns Medical College Hospital
Kormangala
Bangalore 2nd floor, OT complex,
St Johns Medical College Hospital
Kormangala
Bangalore Bangalore KARNATAKA 5600346 India |
Phone |
09449059395 |
Fax |
|
Email |
drmanjula95@yahoo.com |
|
Source of Monetary or Material Support
|
St Johns Medical College Hospital
Kormangala
Bengaluru 560034
Karnataka, India |
|
Primary Sponsor
|
Name |
Shilpa Bhimasen Joshi |
Address |
St Johns Medical College Hospital
Kormangala
Bangalore |
Type of Sponsor |
Other [] |
|
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 |
Shilpa Bhimasen Joshi |
St Johns Medical College |
2nd floor, OT complex
St Johns Medical College
Kormangala
Bangalore Bangalore KARNATAKA |
9901405136
drshilpa.josh@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional ethics Commiittee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
patients posted for lower abdominal and lower limb surgeries, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Group B |
3.6 ml of 0.5% hyperbaric Bupivacaine, Group F : 3.6 ml of 0.5% hyperbaric Bupivacaine in fractionated approach. |
Intervention |
Group F |
2.4cc(2/3rd) will be given first and then the remaining 1.2ml (1/3rd) will be given after 120sec. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
ASA I-II patients undergoing lower abdominal or lower limb surgery under spinal anesthesia |
|
ExclusionCriteria |
Details |
a)Patient refusal
b)Allergy to Bupivacaine
c)Body mass index (BMI) > 35
d)Intra-operative conversion to general anesthesia (GA) / inadequate or failed spinal block
e)Pregnant and lactating mothers
f)Known bleeding diathesis or with any coagulation abnormalities
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To compare the onset, peak and duration of sensory and motor block in fractionated and single bolus dose of spinal anesthesia with 0.5% heavy bupivacaine for lower abdominal and lower limb surgeries. |
5,10,15,20,25,30,60,90,120,150,180,210 minutes after spinal injection |
|
Secondary Outcome
|
Outcome |
TimePoints |
1)To compare the intraoperative hemodynamics heart rate, saturation,systolic blood pressure, diastolic blood pressure, mean blood pressure and any side effects
|
5,10,15,20,25,30,60,90,120,150,180,210 minutes after spinal injection |
|
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)
|
16/04/2018 |
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
|
1)Badheka JP, Oza VP, Vyas A, Baria D, Nehra P, Babu T. Comparison of fractionated
dose versus bolus dose injection in spinal anaesthesia for patients undergoing elective caesarean section: A randomised, double-blind study. Indian J Anaesth 2017;61:55-60
2)K. S. Sunitha, Mohammed Naveed. â€Can Fractionated Spinal Anesthesia Be An
Economical Alternative Technique To Combined Spinal-Epidural Anesthesia??â€. Journal of Evidence based Medicine and Healthcare; Volume 2, Issue 5, February 02, 2015; Page: 477-86.
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
After
ethical committee approval and informed consent, patients will be recruited for
the study. Preoperative evaluation is doneand the subjects will be randomized via computer
generated table and allocated to one of
the groups. Group B: 3.6 ml of
0.5% hyperbaric Bupivacaine,
Group F : 3.6 ml of 0.5% hyperbaric Bupivacaine in fractionated
approach. Demographic details (Age,
sex, weight, ASA status, height) will be noted.
As
a standard practice, pre-operatively patients will be kept fasting for 6 hours.
They will be routinely premedicated with Tab. Alprazolam 0.5 mg and Tab.
Pantoprazole 40 mg on the night prior to surgery and on the morning of
surgery.
Intraoperatively
patients will be monitored by electrocardiography, non-invasive blood pressure
and pulse oximetry. In group B - Spinal
anesthesia will be given with 3.6cc of 0.5% heavy Bupivacaine at L3-4
interspace via 25 G spinal needle, with subject in the sitting position . In group F - Spinal
anesthesia of 3.6cc of 0.5% heavy
Bupivacaine at L3-4 interspace via 25 G spinal needle will be given in a
fractionated approach where 2.4cc(2/3rd) will be given first and
then the remaining 1.2ml (1/3rd) will be given after 120sec.The
subject will made to lie supinesoon after the injection. At 5 mins after the
injection, level of block –sensory by pinprick and motor by bromage scale will
be checked. This will be considered as
onset of sensory and motor block. At
20min, the peak level of sensory and motor block willalso be noted.
The
duration of spinal anesthesia is considered as two segment regression from the level of sensory block achieved at 20min(peak) of sensory block . At the end
of surgery, both the sensory level and motor block will be rechecked. Vitals
such as Heart rate (HR), Systolic blood pressure (SBP), Diastolic
blood pressure (DBP), Mean arterial blood pressure (MAP), saturation (SpO2)
will be measured at every 5 mins for 1sthour
and then 10min till the end of surgery.
Any
side effects of the spinal anesthesia such as: Bradycardia (HR < 20% of
baseline), Hypotension (BP < 25% of baseline), Respiratory depression,
Sedation, Pruritis and Nausea/ Vomiting will be noted and treated
appropriately. Bradycardia will be treated with Injection Atropine 20mcg/kg IV
and Hypotension by IV fluids/ injection Mephentermine 3 mg IV boluses.
The
data will be collected in the study proforma and analyzed for statistical
significance with the statistician. |