| CTRI Number |
CTRI/2018/12/016624 [Registered on: 12/12/2018] Trial Registered Prospectively |
| Last Modified On: |
11/12/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective,comparative clinical study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of bolus dose of local anaesthetic in spinal anaesthesia over the same dose given in fractions in pregnant patients posted for caesarean section. |
|
Scientific Title of Study
|
“Comparison of fractionated versus bolus dose of bupivacaine heavy(0.5%) in spinal anaesthesia for elective caesarean section-A prospective,randomized,single blind,clinical trial†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Darshna Dharmendra Patel |
| Designation |
Assistant Professor |
| Affiliation |
Govt.Medical College,Vadodara |
| Address |
202,VAIDEHI RESIDENCY
44/1,ARUNODAY SOCIETY,
ALKAPURI,
VADODARA-390007
,
Vadodara
GUJARAT
390007
India |
| Phone |
919925013155 |
| Fax |
|
| Email |
dr.darshna1968@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Darshna Dharmendra Patel |
| Designation |
Assistant Professor |
| Affiliation |
Govt.Medical College,Vadodara |
| Address |
202,VAIDEHI RESIDENCY
44/1,ARUNODAY SOCIETY,
ALKAPURI,
VADODARA-390007
,
Vadodara
GUJARAT
390007
India |
| Phone |
919925013155 |
| Fax |
|
| Email |
dr.darshna1968@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Darshna Dharmendra Patel |
| Designation |
Assistant Professor |
| Affiliation |
Govt.Medical College,Vadodara |
| Address |
202,VAIDEHI RESIDENCY
44/1,ARUNODAY SOCIETY,
ALKAPURI,
VADODARA-390007
,
Vadodara
GUJARAT
390007
India |
| Phone |
919925013155 |
| Fax |
|
| Email |
dr.darshna1968@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College,
Jail Road
Anandpura,
Vadodara |
|
|
Primary Sponsor
|
| Name |
Medical CollegeVadodara |
| Address |
Medical College S.S.G.Hospital Jail Road Vadodara
|
| Type of Sponsor |
Government 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 Darshna D Patel |
S.S.G.Hospital,Medical College,Vadodara |
Department of Anaesthesiology,
S.S.G.Hospital, Medical
College, Jail Road,
Vadodara
Vadodara
GUJARAT
Vadodara
GUJARAT |
9925013155
dr.darshna1968@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee For Human Reasearch(IECHR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA Physical status I and II |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1) Pregnant Patients posted for elective caesarean section
2)American Society of Anaesthesiologists physical
status I–II,
3) Age from 18 to 40 years
4) Height from 140 to 180 cm
5)Singleton pregnancies
|
|
| ExclusionCriteria |
| Details |
1)Patients not willing for regional anaesthesia
2)Patient having allergy to study drug
3)Patients with all the contraindications for spinal anaesthesia like fixed cardiac output states, raised intracranial pressure, spinal deformity, patients with Coagulation abnormality and patients with local skin infection at spinal site
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)To monitor pulse rate, systolic blood pressure, diastolic blood pressure and mean arterial blood pressure intraoperatively
2)To monitor duration of sensory block and motor block
3)To monitor duration of effective analgesia
|
Intra and postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To monitor for any complications e.g. Bradycardia, Hypotension. Nausea, Vomitting, shivering and Respiratory depression
2) To monitor APGAR Score at 1 minute and 5 minutes
|
Intra and postoperatively |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
20/12/2018 |
| 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="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study will be carried out in Government Medical College Vadodara. Overall Purpose to carry out this study is to know the effects of fractionated dose versus bolus dose of bupivacaine given in spinal anaesthesia primarily on haemodynamic parameters and duration of effective analgesia in pregnant patients undergoing elective caesarean section. |