| CTRI Number |
CTRI/2022/05/042898 [Registered on: 30/05/2022] Trial Registered Prospectively |
| Last Modified On: |
29/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the characteristics of two durgs (hyperbaric (0.5%) Bupivacaine and hyperbaric (0.75%) Ropivacaine ) which is used for loss of pain sensation over lower half of body by giving injection in lower vertebral canal in Cesarean Section. |
|
Scientific Title of Study
|
Block characteristics of hyperbaric (0.5%) Bupivacaine versus hyperbaric (0.75%) Ropivacaine for spinal anaesthesia in Lower Segment Cesarean Section: A randomized experimental study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohammed Firoz Sheikh |
| Designation |
pg student |
| Affiliation |
pt . j. n. m. medical college raipur chhattisgarh. |
| Address |
Department of Anesthesiology and Pain management Pt JNM Medical
college Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
8319824046 |
| Fax |
|
| Email |
firozsheikh78@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratibha Jain Shah |
| Designation |
Professor and HOD |
| Affiliation |
pt . j. n. m. medical college raipur chhattisgarh. |
| Address |
Department of Anesthesiology and pain management Pt JNM Medical
college Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
9827276620 |
| Fax |
|
| Email |
prati_jain@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratibha Jain Shah |
| Designation |
Professor and HOD |
| Affiliation |
pt . j. n. m. medical college raipur chhattisgarh |
| Address |
Department of Anesthesiology and pain management Pt JNM Medical
college Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
9827276620 |
| Fax |
|
| Email |
prati_jain@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology and pain management,,Dr Bhim Rao Ambedkar Memorial hospital , Raipur, chhattisgarh 492001 |
|
|
Primary Sponsor
|
| Name |
DR PRATIBHA JAIN SHAH |
| Address |
Department of Anesthesiology and critical care Pt JNM Medical
college Raipur |
| Type of Sponsor |
Other [] |
|
|
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 Mohammed Firoz Sheikh |
Dr Bhim Rao Ambedkar Memorial Hospital ,Raipur |
Department of Anaesthesiology , Pt JNM Medical College ,Raipur,Chhattisgarh , 492001.
Raipur
CHHATTISGARH |
8319824046
firozsheikh78@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee PT JNM Medical college Raipur |
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 |
hyperbaric (0.5%) Bupivacaine |
hyperbaric (0.5%) Bupivacaine for spinal anaesthesia in Lower Segment Cesarean Section. spinal anaesthesia will be given within 30 min after arrival of patient in operation theater and surgery will be completed within 2 hours . |
| Comparator Agent |
hyperbaric (0.75%) Ropivacaine |
hyperbaric (0.75%) ropivacaine for spinal anaesthesia in Lower Segment Cesarean Section. spinal anaesthesia will be given within 30 min after arrival of patient in operation theater and surgery will be completed within 2 hours . |
| Intervention |
spinal anaesthesia for lower segment cesarean section |
hyperbaric (0.75%) ropivacaine for spinal anaesthesia in Lower Segment Cesarean Section. spinal anaesthesia will be given within 30 min after arrival of patient in operation theater and surgery will be completed within 2 hours . |
| Intervention |
spinal anaesthesia for lower segment cesarean section |
hyperbaric (0.5%) Bupivacaine for spinal anaesthesia in Lower Segment Cesarean Section. spinal anaesthesia will be given within 30 min after arrival of patient in operation theater , and surgery will be completed within 2 hours . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1 ASA grade
2 Age between 18 to 40 yrs .
3 BMI <30 KG/M2
4 Height 150-170 cm.
5 Elective cesarean section under spinal anaesthesia. |
|
| ExclusionCriteria |
| Details |
1 Refusal.
2 Any neurological condition like demylinating lesions,increased intracranial tension, and head injuries .
3 Diabetes mellitus,hypertension,renal,hepatic ,pulmonary or pre-existing cardiac diseases(severe mitral stenosis or severe aortic stenosis).
4 Contraindication to spinal anaesthesia.
5 Chronic pain medication.
6 bleeding or coagulation disorders and those on
anticoagulant therapy.
7 History to allergy of study drug.
8 Partial or failed Spinal anaesthesia . |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1 Onset of sensory block at the T10 level |
WITHIN 30 MIN after spinal anaesthesia for LSCS. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Onset of motor block.
2 Duration of sensory & motor block.
3 Grade of sensory & motor block.
4 Duration of analgesia .
5 Hemodynamic changes( BP ,HR ,RR, SpO2)
6 Side effects and complications(nausea, vomiting, hypotension, shivering ,respiratory distress )
|
JUST AFTER SPINAL ANAESTHESIA TILL 24-48 HOURS |
|
|
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)
|
31/05/2022 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 11-05-2022 and end date provided 11-12-2024?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
In this study we give one of the our study drug to pregnant patients for lscs in spinal anaesthesia.We use double blind
technique .in which patient and investigator will be blind to study drug which
will be given to patient .The drug will be prepared by an anaesthesiologist
other than the principal investigator, who will be blinded to the study
protocol and will not be involved in further data collection and assessment of
patient . All patients will be informed and explained about the procedure .the
multipara monitor will be attached to patients in supine position and baseline
vital parameters such as BP, HR , RR and SpO2 will be recorded. An intravenous
line will be established with 18 g cannula to preload the patient with ringer
lactate solution at 10 ml /kg before the initiation of spinal block. Then
premedication will be done with inj ondansetron 4mg iv .spinal anaesthesia will
be given at sitting position at the L3-L4 level identified by land mark
technique . with a 25-g Quincke’s spinal needle .our primary outcome is onset
of sensory block at the t10 level and secondary outcome are onset of
motor block, duration of sensory & motor block.grade of sensory &
motor block,duration of analgesia ,hemodynamic changes( BP ,HR ,RR, SpO2). side
effects and complications(nausea, vomiting, hypotension, shivering ,respiratory
distress ) . |