| CTRI Number |
CTRI/2024/05/067351 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
15/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effects of two different local anesthetic agents in spinal anesthesia for elective caesarean delivery |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF INTRATHECAL HYPERBARIC BUPIVACAINE WITH FENTANYL AND INTRATHECAL HYPERBARIC ROPIVACAINE WITH FENTANYL IN ELECTIVE LOWER SEGMENT 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 |
Rajarajeswari M |
| Designation |
Junior Resident in Anaesthesiology |
| Affiliation |
Sree Balaji Medical College and Hospital |
| Address |
Department of Anaesthesiology Sree Balaji Medical College and Hospital
No7 CLC Works Road
chromepet
Chennai
TAMIL NADU
600044
India |
| Phone |
8939416600 |
| Fax |
|
| Email |
simpsonsapr24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kala B |
| Designation |
Professor of Anesthesiology |
| Affiliation |
Sree Balaji Medical College and Hospital |
| Address |
Department of Anaesthesiology
First floor Sree Balaji Medical College Hospital
No 7 CLC Works road
chromepet Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
9444680908 |
| Fax |
|
| Email |
kalamhn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kala B |
| Designation |
Professor of Anesthesiology |
| Affiliation |
Sree Balaji Medical College and Hospital |
| Address |
Department of Anaesthesiology
First floor Sree Balaji Medical College Hospital
No 7 CLC Works road
chromepet Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
9444680908 |
| Fax |
|
| Email |
kalamhn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sree Balaji Medical College, No7, CLC Works road, Chrompet, Chennai-600044 |
|
|
Primary Sponsor
|
| Name |
Sree Balaji Medical College and Hospital |
| Address |
Sree Balaji Medical College and Hospital CLC works road Chrompet Chennai 600044 |
| 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 Rajarajeswari M |
Sree Balaji Medical College Hospital |
OBG operating room complex First floor
Department of Anaesthesiology
Sree Balaji Medical College and Hospital
NO 7
CLC Works road
Chromepet Chennai 44
Chennai
Chennai
TAMIL NADU |
8939416600
simpsonsapr24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethicscommittee Sree Balaji Medical College and Hospital |
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 |
| Intervention |
Group BF: Received 10 mg (2ml) 0.5% hyperbaric bupivacaine with 20 microgram fentanyl |
This is a Prospective study of six months duration
During the study period Patients posted for
elective LSCS under ASA I &II will be randomly taken as Group BF and Group RF.
Group BF women posted for elective LSCS will receive
2ml of intrathecal 0.5% Bupivacaine with 20 mic fentanyl |
| Intervention |
Group RF: Received 15 mg (2ml) 0.75% hyperbaric Ropivacaine with 20 microgram fentanyl |
This is a Prospective study of six months duration
During the study period, Patients posted for
elective LSCS under ASA I &II will be randomly taken as Group BF and Group RF. Group RF women posted for elective LSCS will receive intrathecally 2ml of hyperbaric 0.75% Ropivacaine and 20 mic fentanyl |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Those who consented to be part of the study and gave written consent
women who are undergoing elective cesarean section for baby delivery
ASA II patients. |
|
| ExclusionCriteria |
| Details |
ASA Grade III or Above
Patients in whom spinal anesthesia was contraindicated
Pre-operative hemodynamic instability, maternal heart disease, and severe anaemia
History of allergy to local anaesthetic or opioids. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the onset of analgesia between the two different study groups concerning the nature of sensory block, motor block, and duration of analgesia. |
After the Administration of intrathecal local anaesthetics and opioids postoperatively, the patient is observed every 15mins 30 minutes 1 hr then every 1hr up to 24hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find out the effectiveness and hemodynamics of the drugs.
To find out the Pain score at 30 min,4hr, 8hr, 12hr post-op. |
To find out the hemodynamics changes at 1,3,5,10,15,30,45,60 minutes after spinal anaesthesia
To find out the Pain score at 30 min,4hr, 8hr, 12hr post-op. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/06/2024 |
| Date of Study Completion (India) |
31/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 anaesthesia is the standard Anesthetic choice for lower segment cesarean section (LSCS), except in a few cases where it is contraindicated. This study is to compare the effects of the combination of either Ropivacaine, or Bupivacaine with fentanyl (one of the most used adjuvants in intrathecal administration). they have additive effects when applied together in the subarachnoid space, with greater analgesic quality and duration, safety, and also longer-lasting post-surgical analgesia, which is clinically significant. The rationale behind this study is to observe and assess the effect of 0.5%hyperbaric bupivacaine with fentanyl and 0.75% hyperbaric ropivacaine with fentanyl when administered through intrathecal route for elective caesarean deliveries |