| CTRI Number |
CTRI/2024/02/063381 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
29/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of two local anaesthetics drugs in elective lower segment caesarean section surgeries |
|
Scientific Title of Study
|
Intrathecal Isobaric Levobupivacaine 0.5% with fentanyl versus Isobaric Ropivacaine 0.5% with fentanyl in elective lower segment caesarean section surgeries:a prospective randomized clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Disha Juneja |
| Designation |
Junior Resident |
| Affiliation |
Mahatma Gandhi Medical College and Hospital,Sitapura |
| Address |
Gynae OT complex
Mahatma Gandhi Medical College and Hospital, Sitapura,Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
07976812123 |
| Fax |
|
| Email |
dishajuneja36@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpana Verma |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Medical College and Hospital,Sitapura |
| Address |
Gynae OT complex Mahatma Gandhi Medical Hospital
Mahatma Gandhi Medical College and Hospital, Sitapura Tonk road,Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
7727886029 |
| Fax |
|
| Email |
kalpana2007.kv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Disha Juneja |
| Designation |
Junior Resident |
| Affiliation |
Mahatma Gandhi Medical College and Hospital,Sitapura |
| Address |
Gynae OT complex
Mahatma Gandhi Medical College and Hospital, Sitapura Tonk road,Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
07976812123 |
| Fax |
|
| Email |
dishajuneja36@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Hospital,Jaipur |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College and Hospital |
| Address |
Mahatma Gandhi Medical College and Hospital, Sitapura Tonk road,Jaipur |
| 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 Disha Juneja |
Mahatma Gandhi Medical College and Hospital OT complex |
Gynae OT complex
OT 1,2
Department of Anaesthesia
Jaipur
RAJASTHAN |
7976812123
dishajuneja36@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR RAJENDRA KUMAR SUREKA, MEMBER SECRETARY, IEC |
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 |
| Comparator Agent |
Subarachnoid block |
To study duration of post-operative analgesia following intrathecal 0.5% Isobaric Ropivacaine with fentanyl.
Post operative follow up for 12 hours. |
| Intervention |
subarachnoid block |
To study duration of post-operative analgesia following intrathecal 0.5% Isobaric Levobupivacaine with fentanyl in Elective Caesarean section surgeries. Post operative follow up for 12 hours. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women aged 20 years to 45 years of age scheduled for lowert segment C section surgeries will be enrolled in this prospective study. |
|
| ExclusionCriteria |
| Details |
Pt refusal,contraindication for spinal anesthesia,coagulopathy,morbid obesity.infection at the site |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study duration of post-operative analgesia following intrathecal 0.5% Isobaric Ropivacaine with fentanyl and 0.5% Isobaric Levobupivacaine with fentanyl in Elective Caesarean section surgeries |
24 hours post- operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the need for rescue analgesia |
24 hours |
|
|
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)
|
11/03/2024 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| 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 ethical commite approval, sample of 60 pregnant females taken for subarachnoid block. Drugs used are isobaric Ropivacaine with adjuvant fentanyl and isobaric Levobupivacaine with fentanyl in L3 L4 space. Sensory and motor effects of the block studied.Time to regression of motor block and duration of post operative analgesia studied. |