| CTRI Number |
CTRI/2024/12/077813 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
02/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A Study to Compare Bupivacaine and Levobupivacaine in spinal anesthesia for pregnant patients |
|
Scientific Title of Study
|
Comparative evaluation of the efficacy and safety of INTRATHECAL 0.5% hyperbaric Levobupivacaine with 0.5% hyperbaric Bupivacaine in patients undergoing LSCS under spinal anesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashish Kumar Sharma |
| Designation |
PG Resident Anesthesia first year |
| Affiliation |
Pacific Medical College and Hospital Udaipur |
| Address |
Pacific Medical College and Hospital
Bhilon Ka Bedla
Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9311429122 |
| Fax |
|
| Email |
drashu.sharma19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sameer Goyal |
| Designation |
Professor- Department of Anesthesia |
| Affiliation |
Pacific Medical College and Hospital Udaipur |
| Address |
Pacific Medical College and Hospital
Department of Anesthesia
Bhilon Ka Bedla
Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
8890802830 |
| Fax |
|
| Email |
sameergoy@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashish Kumar Sharma |
| Designation |
PG Resident Anesthesia First year |
| Affiliation |
Pacific Medical College and Hospital Udaipur |
| Address |
Pacific Medical College and Hospital
Department of Anesthesia
Bhilon Ka Bedla
Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
09311429122 |
| Fax |
|
| Email |
drashu.sharma19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pacific Medical College and Hospital
Department of Anesthesia
Bhilon Ka Bedla
Udaipur
Pin 313001
Rajasthan
India |
|
|
Primary Sponsor
|
| Name |
pacific medical college and hospital |
| Address |
Pacific Medical College and Hospital
Department of Anesthesia
Bhilon Ka Bedla
Udaipur
Pin 313001
Rajasthan
India |
| 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 SAMEER GOYAL |
Pacific Medical College and Hospital,Udaipur |
Pacific Medical College and Hospital
Department of Anesthesia
Bhilon Ka Bedla
Udaipur
pin 313001
Udaipur
RAJASTHAN |
08890802830
sameergoy@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Pacific Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O60-O77||Complications of labor and delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bupivacaine |
2.2 ml 0.5% heavy intrathecal injection |
| Comparator Agent |
Levobupivacaine |
2.2ml 0.5% heavy intrathecal injection |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Informed Consent.
2.Pregnant females scheduled to undergo lower
segment caesarean section (LSCS) under spinal
anesthesia.
3.American Society of Anesthesiologists (ASA)
grade I & II.
4.Age 18-35 years
|
|
| ExclusionCriteria |
| Details |
1.Refusal to give consent.
2.Emergency LSCS.
3.Drug allergy to local anaesthetics / study
drugs.
4.ASA grade III and above.
5.AGE less than 18 years or more than 35years.
6.Weight less than 50 Kgs or more than 90Kgs.
7.Height less than 5 feet.
8.Twin /Complicated pregnancy.
9.Any contraindication to regional anesthesia.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 0.5% hyperbaric Levobupivacaine is better in efficacy and safety in comparison to 0.5% hyperbaric Bupivacaine in LSCS under spinal anesthesia. |
24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Is 0.5% hyperbaric Levobupivacaine better in terms of efficacy and safety profile with routinely used drug 0.5% hyperbaric bupivacaine in spinal anesthesia.
|
24 months |
|
|
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 4 |
|
Date of First Enrollment (India)
|
16/12/2024 |
| 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="2"
Months="0"
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
|
After obtaining approval from hospital ethical committee and written informed consent, patients will be divided into two groups randomly. All patients will be assessed before surgery for anesthesia fitness. Patients will be prepared by fasting (8 h for solid foods, 4 hours for clear fluids). On arrival to the operating room, ASA standard monitoring will be applied to all patients, including pulse oximeter, electrocardiogram and noninvasive arterial blood pressure. An 18/20 -gauge intravenous catheter will be placed and 10ml/kg lactated Ringer solution as preloading before spinal Anesthesia will be given to all patients, Under all aseptic precautions subarachnoid block will be performed at L3-L4 interspace with patient in sitting position, using either 2.2ml of 0.5% hyperbaric Levobupivacaine (Group L) or 2.2 ml of 0.5% hyperbaric Bupivacaine (Group B). After spinal block, patients will be placed in supine position and oxygen will be provided via a facemask. Sensory and motor block will be assessed by an anesthesiologist. The segmental level of sensory block will be assessed by loss of sensation to pin-prick.
|