| CTRI Number |
CTRI/2023/09/057384 [Registered on: 11/09/2023] Trial Registered Prospectively |
| Last Modified On: |
06/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparison of rate of speed of local anesthestic during spinal anesthesia on caesarean section and effect of sensory block and incidence of hypotension in pregnant females |
|
Scientific Title of Study
|
A Comparison of the injection rate of local anaesthetic during spinal anesthesia on the onset of sensory block and incidence of hypotension in Caesarean section |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SOUNDHARYA T |
| Designation |
Second year resident |
| Affiliation |
BJ medical college , Asarwa , Ahmedabad |
| Address |
New PG hostel, Phase 1, Civil hospital campus, Asarwa, Ahmedabad
F3, first floor department of Anesthesiology, civil hospital Ahmedabad -380016
Ahmadabad
GUJARAT
380016
India |
| Phone |
8056355004 |
| Fax |
|
| Email |
sindhu66@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr smita R Engineer |
| Designation |
professor |
| Affiliation |
BJMC civil hospital asarwa ahmedabad |
| Address |
F3 block , 1st floor , department of anesthesiology , civil hospital , asarwa , ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9825504948 |
| Fax |
|
| Email |
seng_90@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr smita R Engineer |
| Designation |
professor |
| Affiliation |
BJMC civil hospital asarwa ahmedabad |
| Address |
F3 block , 1st floor , department of anesthesiology , civil hospital , asarwa , ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9825504948 |
| Fax |
|
| Email |
seng_90@yahoo.com |
|
|
Source of Monetary or Material Support
|
| 7th floor, 7th block, Health and family welfare department,new sachivalay,Gandhinagar
|
|
|
Primary Sponsor
|
| Name |
Civil hospital |
| Address |
7th floor, 7th block health and family welfare department new sachavalay , gandhinagar , gujarat |
| 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 Soundharya T |
Civil hospital Ahmedabad |
ground floor, D0, 1200 bed hospital, civil hospital campus, Asarwa, Ahmedabad
Ahmadabad
GUJARAT |
8056355004
sindhu66@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional ethics commitee BJ medical college and civil hospital , Ahmedabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, (2) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj bupivacaine 0.5% heavy |
Bupivacaine is a local anesthetic used for spinal anesthesia and its rate of speed of injection is compared in view of sensory block and maternal hypotension |
| Comparator Agent |
Speed at which Inj Bupivacaine 0.5% heavy injected |
comparison of fast (15sec)
and slow (60 sec) Speed at which Inj Bupivacaine 0.5% heavy injected for spinal anesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1 Patients willing to consent for the study
2 Elective caesarean section delivery
3 American Society of Anaesthesiologists class I, II, III
4 Age 18 – 40 years
5 Singleton pregnancy
|
|
| ExclusionCriteria |
| Details |
1 Pregnant patients with contraindications for spinal anaesthesia
2 Placental anomaly
3 Hypertension
4 Known case of cardiac, hepatic, renal disease, vascular disease
5 Hemodynamic instability
6 Spinal deformity
• Patients with weight <50kg or > 80kg and Height <140cm or >160cm
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to reach level of sensory block at T6 |
From Time to inject the drug & time to get level of sensory block at T6, time to achieve complete motor block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| maternal hypotension, any other complications |
from time to inject the drug up to the postoperative one hour |
|
|
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 2 |
|
Date of First Enrollment (India)
|
15/09/2023 |
| 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="0"
Months="6"
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 - NO
|
|
Brief Summary
|
Spinal anesthesia is the most common anesthesia for Caesarean section due to lower exposure of the fetus to drugs, creating profound sensory and motor block as well as low risk of pulmonary maternal aspiration. Many factors such as type of local anesthetic, dose, rate of injection, volume of subarachnoid space, patient’s position play a role for adequate sensory block level in caesarean section with spinal block. Hypotension is the most common complication of spinal anesthesia. The most feared effect of hypotension is that it may lead to fetal hypoxia and acidosis by reducing uteroplacental perfusion if not treated timely. In current study, we hypothesized that there may be delay in reaching the level of sensory block with turbulent flow caused by rapid local anesthetic injection. We aimed to investigate the effects of 2 injection rates that is not close to each other to achieve a sensory block level and intraoperative maternal hypotension and any other complications in elective caesarean section surgeriese |