| CTRI Number |
CTRI/2023/05/053035 [Registered on: 22/05/2023] Trial Registered Prospectively |
| Last Modified On: |
18/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of 2 drugs in Spinal Anaesthesia for Caesarean sections. |
|
Scientific Title of Study
|
A Comparative Study Of Intrathecal 1% 2-Chloroprocaine With Fentanyl And Dexamethasone As Adjuvant In Elective 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 |
DR RICHA KACHHAWA |
| Designation |
MBBS, MD, Senior Resident,Department Of Anaestheia |
| Affiliation |
Sardar Patel Medical College, Bikaner, Rajasthan |
| Address |
DEPARTMENT OF ANAESTHESIA, SARDAR PATEL MEDICAL COLLEGE, BIKANER, RAJASTHAN
Bikaner
RAJASTHAN
334001
India |
| Phone |
8619384153 |
| Fax |
|
| Email |
richakachhawa1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ANITA PAREEK |
| Designation |
MBBS, MD, ADDITIONAL PRINCIPAL AND HEAD OF DEPARTMENT |
| Affiliation |
SARDAR PATEL MEDICAL COLLEGE, BIKANER |
| Address |
DEPARTMENT OF ANAESTHESIA, SARDAR PATEL MEDICAL COLLEGE, BIKANER, RAJASTHAN
Bikaner
RAJASTHAN
334001
India |
| Phone |
982810281 |
| Fax |
|
| Email |
dranitapareek23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ANITA PAREEK |
| Designation |
MBBS, MD, ADDITIONAL PRINCIPAL AND HEAD OF DEPARTMENT |
| Affiliation |
SARDAR PATEL MEDICAL COLLEGE, BIKANER |
| Address |
DEPARTMENT OF ANAESTHESIA, SARDAR PATEL MEDICAL COLLEGE, BIKANER, RAJASTHAN
Bikaner
RAJASTHAN
334001
India |
| Phone |
982810281 |
| Fax |
|
| Email |
dranitapareek23@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIA, SARDAR PATEL MEDICAL COLLEGE, BIKANER, RAJASTHAN |
|
|
Primary Sponsor
|
| Name |
Sardar Patel Medical College Bikaner Rajasthan |
| Address |
Department Of Anaesthesiology,Sardar Patel Medical College, Bikaner, Rajasthan |
| 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 |
| Richa Kachhawa |
Sardar Patel Medical College, Bikaner, Rajasthan |
Department of Anaesthesiology, Sardar Patel Medical College, Bikaner, Rajasthan
Bikaner
RAJASTHAN |
8619384153
richakachhawa1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Research Board |
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 |
| Comparator Agent |
1% 2- Chloroprocaine, Fentanyl And Dexamethasone. |
Comparison Of Intrathecal Chloroprocaine with Fentanyl (2.5ml 1% 2- Chloroprocaine + 0.5ml Fentanyl + 0.5ml Normal saline) in Group A and Chloroprocaine with Dexamethasone (2.5ml 1% 2- Chloroprocaine + 1 ml Dexamethasone) in Group B patients, for elective Caesarean section. Observing the sensory and motor block characteristics and hemodynamic stability, after administering Spinal Anaesthesia till 8 hours after Caesarean section. |
| Intervention |
Spinal Anaesthesia |
Infilteration Of Drug In Subarachanoid Space |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
ASA Grade 2, Age 18-35 years,Term Parturients ,BMI 20-29.9 kg/m2,Live Foetus |
|
| ExclusionCriteria |
| Details |
Patient Refusal, ASA Grade >2, Allergy, Sepsis, Spinal Deformities, Coagulation Defects |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy and safety of 1% 2- Chloroprocaine with Fentanyl and Dexamethasone as spinal anaesthetic agent in elective caesarean section in relation to -
1. Onset, duration and quality of sensory and motor block.
2. Duration of post operative analgesia. |
Till the drug effect is over. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the hemodynamic parameters, To observe Surgeon’s & Patient’s satisfaction, To observe any side effects and complications related to drugs and procedure. |
8 hrs |
|
|
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)
|
01/06/2023 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Spinal anaesthesia has long been the preferred choice, by both the surgeons and patients, for Caesarean sections. Most common drug used in spinal anaesthesia is 0.5% Bupivacaine, which is cardiotoxic and has many side effects. In our study , we plan to use 1% 2- Chloroprocaine as intrathecal drug for Spinal anaesthesia, which has been studied extensively for short surgical procedures. We plan to compare adjuvants Fentanyl and Dexamethasone along with 1% 2- Chloroprocaine for Spinal anaesthesia..Our aim will be to compare the efficacy and safety of intrathecal 1% 2-Chloroprocaine with fentanyl and dexamethasone as adjuvant in LSCS in relation to onset, duration and quality of sensory & motor block, and complications, if any. |