| CTRI Number |
CTRI/2025/06/088553 [Registered on: 10/06/2025] Trial Registered Prospectively |
| Last Modified On: |
09/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISON OF FRACTIONATED WITH BOLUS DOSE OF SPINAL ANESTHESIA IN PATIENTS UNDERGOING CAESAREAN SECTION |
|
Scientific Title of Study
|
COMPARISON OF FRACTIONATED DOSE WITH BOLUS DOSE OF 0.5 PERCENT HYPERBARIC BUPIVACAINE IN SPINAL ANAESTHESIA FOR PATIENTS UNDERGOING CAESAREAN SECTION |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Kaushik |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
SGT UNIVERSITY, Chandu budhera |
| Address |
Department of Anaesthesia and Critical Care,SGT University
Budhera, Gurugram , Haryana
Gurgaon
HARYANA
122505
India |
| Phone |
9910868912 |
| Fax |
|
| Email |
kaushikpriyanka560@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Savita Saini |
| Designation |
Professor Anaesthesia Department |
| Affiliation |
SGT University, Chandu budhera |
| Address |
Department Of Anaesthesia and Critical Care
Budhera, Gurugram, Haryana
Gurgaon
HARYANA
122505
India |
| Phone |
9416262343 |
| Fax |
|
| Email |
dr_savitasaini@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Kaushik |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
SGT University, Chandu budhera |
| Address |
Department of Anaesthesia and Critical Care, SGT University
Budhera, Gurugram, Haryana
Gurgaon
HARYANA
122505
India |
| Phone |
9910868912 |
| Fax |
|
| Email |
kaushikpriyanka560@gmail.com |
|
|
Source of Monetary or Material Support
|
| FMHS,SGT University, Chandu budhera, Gurugram , Haryana 122505 |
|
|
Primary Sponsor
|
| Name |
Priyanka kaushik |
| Address |
Department of Anaesthesia and Critical Care , SGT University
Budhera, Gurugram, Haryana |
| 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 Priyanka Kaushik |
SGT hospital |
FMHS, Anaesthesia department 1st floor
SGT hospital
Sgt university budhera
Gurugram Haryana
Gurgaon
HARYANA |
9910868912
kaushikpriyanka560@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Faculty of Medicine and Health Sciences , SGT university,INSTITUTIONSAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.5% Hyperbaric bupivacaine as bolus |
2ml 0.5% hyperbaric bupivacaine to be given as bolus without any adjuvants. |
| Comparator Agent |
0.5% Hyperbaric bupivacaine as fractionated dose |
2 ml of 0.5% Hyperbaric bupivacaine to be given as fractionated dose 2/3 of drug followed by 1/3 of drug after waiting for 45seconds |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
36.00 Year(s) |
| Gender |
Female |
| Details |
1) Physical status I-III according to American Society of Anaesthesiologist
2) Singleton live pregnancies more than 37 weeks of gestation for elective or emergency caesarean
3) Body mass index less than 30 |
|
| ExclusionCriteria |
| Details |
1)Patients wit pre-existing diseases like cardiovascular or cerebrovascular disease or pregnancy induced hypertension
2) Severely altered mental status
3)Spinal deformities
4) History of laminectomy
5) Any contraindication to spinal anaesthesia
6) Emergency caesarean section who cannot be explained about the study due to paucity of time |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Severity of pain assessment using VAS pain score and modified bromage scale |
2,4,6,8,10,15,20,30,40,50 and 60 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Hemodynamic parameters variations
2) Block characteristics |
2,4,6,8,10,15,20,30,40,50 & 60 mins |
|
|
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)
|
20/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/06/2025 |
| 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 Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
This study is a comparative randomised observational study of fractionated with bolus dose of 0.5% hyperbaric bupivacaine in spinal anaesthesia for patients undergoing caesarean section. The comparison between fractionated and bolus doses of hyperbaric bupivacaine in spinal anesthesia for cesarean section involves evaluating their effects on both maternal and fetal outcomes, as well as the quality of anesthesia, side effects, and duration of action. Total 60 patients will be randomly selected which belongs to ASA I -III. 60 patients will be divided into two groups 30 in each by using sealed envelope technique. One group will receive drug as bolus and other will receive drug as fractionated and drug will be given to pregnant females via spinal anaesthesia under all aseptic precautions. |