| CTRI Number |
CTRI/2024/05/067399 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
14/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Intrathecal hyperbaric bupivacaine versus hyperbaric ropivacaine in spinal anaesthesia in caesarean sections: a randomised control trial in a teaching hospital in northeast India. |
|
Scientific Title of Study
|
Intrathecal hyperbaric bupivacaine versus hyperbaric ropivacaine in spinal anaesthesia in caesarean sections: a randomised control trial in a teaching hospital in northeast India. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sahani Debbarma |
| Designation |
Post Graduate Trainee |
| Affiliation |
Agartala Government Medical College |
| Address |
3rd floor, NTH,
Dept. Of Anesthesiology,
AGMC & GBP Hospital
Agartala
Room 218,
JR Hostel, AGMC and GBP Hospital, Agartala
West Tripura
TRIPURA
799006
India |
| Phone |
09485060625 |
| Fax |
|
| Email |
sahanidebbarma9562@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anupam Chakrabarti |
| Designation |
Associate Professor |
| Affiliation |
Agartala Government Medical College |
| Address |
Dept of Anesthesiology
AGMC and GBP Hospital, Agartala
Nutan palli,
Ram nagar
West Tripura
TRIPURA
799006
India |
| Phone |
9436123689 |
| Fax |
|
| Email |
dr.anupamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ranjit Reang |
| Designation |
Assistant professor |
| Affiliation |
Agartala Government Medical College |
| Address |
Dept of Anesthesia,AGMC and GBP Hospital, Agartala.
Magnet club,
Vijoy kumar
Agartala
West Tripura
TRIPURA
799006
India |
| Phone |
09485060625 |
| Fax |
|
| Email |
drranjitreang7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dipankar Das
M/s Neon Laboratories
140, Damji Shamji, Industrial Estate, Andheri (E), mumbai 400093
India
|
|
|
Primary Sponsor
|
| Name |
Neon |
| Address |
140, Damji Shamji Industrial Estate, Andheri(E), Mumbai 400093 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Sneha Chakraborty |
Agartala Government Medical College & Govind Ballav Pant hospital |
Ot Complex, Department of Obst and Gynaecology
West Tripura
TRIPURA |
7085901835
snehachakraborty6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for clinical studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O298||Other complications of anesthesiaduring pregnancy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injection Bupivacaine 0.5% hyperbaric solution |
2.4cc of injection Bupivacaine 0.5% hyperbaric solution i.e 12mg
For 12hours duration |
| Intervention |
Ropivacaine 0.75% hyperbaric solution |
2.4cc of injection ropivacaine 0.75% hyperbaric solution i.e 18mg
For 12 hours duration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
i. All patients who will be registered for elective caesarean delivery and belonging to ASA (American Society of Anesthesiologists) grade I & II only.
ii. Patients between 145to 165 cms of height.
iii. Patients who will give valid informed written consent.
iv. Pregnancy over 37 weeks and less than 42 weeks.
v. Patient with weight of 45-95kgs.
vi. Patients with age between 18years and 40 years.
|
|
| ExclusionCriteria |
| Details |
i. Patient with abnormalities and problems in the embryo.
ii. Patient with indication of an emergency caesarean section.
iii. Patients having history of hypersensitivity to anesthetic agents.
iv. Infection at the subarachnoid block injection site.
v. Pre-term and post term delivery.
vi. ASA class higher than II.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the onset of action, duration of sensory and motor block, and duration of effective analgesia induced by intrathecal hyperbaric ropivacaine and hyperbaric bupivacaine in patients undergoing elective caesarean section. |
0,3,6,9,12,15,20,30,45,60,90,120,150,180,240,300,360,480,600,720 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the haemodynamic variables in two groups during the intra operative & post operative period for 12 hours.
2. To evaluate & compare the adverse effects intra-operatively & post-operatively in the two groups.
|
0,3,6,9,12,15,20,30,45,60 min for haemodynamics
Sensory & Motor blockade 15 minutes interval intraoperatively & post operatively |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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 3 |
|
Date of First Enrollment (India)
|
25/05/2024 |
| 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="0"
Months="2"
Days="21" |
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - Only at email-id sahanidebbarma9562@gmail.com
- For how long will this data be available start date provided 01-05-2024 and end date provided 30-06-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Group B of inj bupivacaine 0.5% hyperbaric solution 2.4 cc will be compared with Group R inj ropivacaine 0.75% 2.4 cc hyperbaric solution. Each group 33 each elective caesarean cases will be taken as per inclusion and exclusion criteria. The injection will be given using 25G quinckes spinal needle at L3-4, L4-5 level, sub arachnoid space in sitting position. Onset of sensory, motor blockade, duration regression of sensory (T10)and motor (bromage 0), time of use of rescue analgesia, Intra op nd post op complicationa like nausea, vomiting, bradycardia, hypotension, respiratory depression shivering to be compared Haemodynamics intra op and post op till 12 hours |