| CTRI Number |
CTRI/2022/04/042039 [Registered on: 21/04/2022] Trial Registered Prospectively |
| Last Modified On: |
14/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Intrathecal Injection of same dose of Fentanyl at Different Rates in Patients undergoing Elective LSCS |
|
Scientific Title of Study
|
A prospective randomized controlled double blinded interventional study to compare postoperative analgesia using sequential intrathecal injection of fentanyl at different rates with hyperbaric bupivacaine in lower segment caesarean sections at SMS Medical College, Jaipur during 2021-2023 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harpreet Kaur |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College and Attached Hospitals |
| Address |
Department of Anaesthesiology, Second Floor, Dhanwantari Complex, SMS Medical College, Jaipur
Department of Anaesthesiology, Second Floor, Dhanwantari Complex, SMS Medical College, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9899785993 |
| Fax |
|
| Email |
rupihar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harpreet Kaur |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College and Attached Hospitals |
| Address |
Department of Anaesthesiology, Second Floor, Dhanwantari Complex, SMS Medical College, Jaipur
Department of Anaesthesiology, Second Floor, Dhanwantari Complex, SMS Medical College, Jaipur
RAJASTHAN
302004
India |
| Phone |
9899785993 |
| Fax |
|
| Email |
rupihar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nelwin Jerald Sabu |
| Designation |
Junior Resident |
| Affiliation |
Sawai Man Singh Medical College and Attached Hospitals |
| Address |
Department of Anaesthesiology, Second Floor, Dhanwantari Complex, SMS Medical College, Jaipur
Department of Anaesthesiology, Second Floor, Dhanwantari Complex, SMS Medical College, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9539173820 |
| Fax |
|
| Email |
nelwinjerald@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Second Floor, Dhanwantari Complex, SMS Medical College,JLN Marg, Jaipur, 302004 |
|
|
Primary Sponsor
|
| Name |
Sawai Man Singh Medical College and Hospitals |
| Address |
Department of Anaesthesiology, Second Floor, Dhanwantari Complex, SMS Medical College, Jaipur,302004 |
| Type of Sponsor |
Government 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 Harpreet Kaur |
Sawai Man Singh Medical College and Attached Hospitals |
Department of Anaesthesiology,SMS Medical College,Jaipur
Jaipur
RAJASTHAN |
9899785993
rupihar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sawai Man Singh Medical College ethics Committee |
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 |
inj fentanyl |
Rapid intrathecal injection(1-2sec) of Fentanyl 0.5ml with an insulin syringefollowed by slow injection of 2ml of hyperbaric bupivacaine with a 5ml syringe |
| Comparator Agent |
injection Fentanyl |
Slow intrathecal injection(4-5sec) of 0.5ml fentanyl with an insulin syringe followed by 2ml of Hyperbaric Bupivacaine with a 5ml syringe |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Patients undergoing Elective LSCS under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
1)ASA Grade 3&4,2)Parturients with complicated pregnancies such as those with pre-eclampsia,pregnancy induced hypertension,gestational diabetes,abnormal placenta(placenta previa),multiple gestation,BMI>35 or<22, major systemic diseases(cardiac, renal, liver)
3)Parturients with a need for emergency CS.
4)Parturientswho are allergic to drugs used in this study
5)Parturients contraindicated for spinal anaesthesia
6)Parturients who refused spinal anaesthesia. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total duration of post operative analgesia |
until 6hrs postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haemodynamic Parameters (systolic BP,Diastolic BP, Mean arterial pressure, Heart Rate,spo2) |
baseline,2min,4min,6min,8min ,10 min,15min, 20 min and then every 10 min till 60 min |
| Intra operative Hypotension |
intraoperatively |
| onset of sensory block and highest level of sensory block |
after 10 min |
| onset of motor block |
time taken to achieve a Bromage score of 3 |
| duration of motor block |
time taken to return to a bromage score of 0 |
| Dose of rescue analgesia used |
postoperatively every 30 min until 6hrs |
| Intensity of Post operative Pain assesesd by VAS Score |
postoperatively every 30 min until 6 hrs |
| Spinal anaesthesia related complications |
intraoperatively |
|
|
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)
|
01/05/2022 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this Study we will check the duration of Postoperative Pain relief by injecting the same dose of fentanyl intrathecally at different rates in lower segment cesarean sections using VAS Score |