| CTRI Number |
CTRI/2024/02/063387 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
24/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To find the effect of volume expansion of epidural space on subarachnoid block with hyperbaric bupivacaine in lower abdominal surgeries |
|
Scientific Title of Study
|
Effect of epidural volume expansion on the subarachnoid block with hyperbaric bupivacaine in patients undergoing lower abdominal surgeries |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akriti Sharma |
| Designation |
Junior resident |
| Affiliation |
Chirayu medical College Bhopal |
| Address |
Department of anaesthesiology Chirayu Medical College and hospital Bhopal
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
8823866268 |
| Fax |
|
| Email |
akriti.atulsharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Saurabh Trivedi |
| Designation |
assistant professor |
| Affiliation |
Chirayu medical College Bhopal |
| Address |
Department of Anaesthesiology Chirayu Medical College Bhopal
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
7042461338 |
| Fax |
|
| Email |
drst23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akriti Sharma |
| Designation |
Junior resident |
| Affiliation |
Chirayu medical College Bhopal |
| Address |
Department of anaesthesiology Chirayu medical College and hospital Bhopal
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
8823866268 |
| Fax |
|
| Email |
akriti.atulsharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chirayu Medical College and hospital bairagarh Bhopal 462030 |
|
|
Primary Sponsor
|
| Name |
Chirayu medical College Bhopal |
| Address |
CMCH BHOPAL |
| 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 Akriti Sharma |
chirayu medical college and hospital Bhopal |
Chirayu Medical College and hospital 462030
Bhopal
MADHYA PRADESH |
8823866268
akriti.atulsharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional human ethics committee chirayu medical college and hospital bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Epidural catheter was secured and spinal anaesthesia was given with 2.4 ml heavy bupivacine but 10ml normal saline was not pushed |
| Intervention |
Volume expansion group |
After securing epidural catheter 10 ml normal saline was pushed in epidural space and then spinal anaesthesia was given with 2.4ml heavy bupivacine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients aged 18 to 65 years, belonging to ASA-PS (American Society of Anesthesiology physical status) I, II, undergoing elective lower abdominal surgeries, under combined epidural catheter insertion and subarachnoid block, at Chirayu Medical College & Hospital, Bhopal |
|
| ExclusionCriteria |
| Details |
1. Emergency surgeries
2. ASA-PS (American Society of Anesthesiology physical status) III, IV
3. Local infection at the procedure site
4. Any coagulation disorders
5. Any mental health issues
6. Patients refused to participate in the study
7. Cesarean section
8. Umbilical surgeries |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine and compare the onset, time, and completion of the motor and sensory blockade at the T8 dermatome level with or without epidural volume expansion. |
within 30 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine and compare the haemodynamic changes with or without epidural volume expansion |
every 3 min till 30 min |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
08/03/2024 |
| 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 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
|
In pregnancy, due to increase in intra-abdominal pressure, subarachnoid space volume decreases thereby increasing the effect of local anaesthesia. Thus we hypothesise that expanding the volume of epidural space with normal saline will result in a similar scenario resulting in the decreased requirement of local anaesthesia. |