| CTRI Number |
CTRI/2014/06/004698 [Registered on: 23/06/2014] Trial Registered Retrospectively |
| Last Modified On: |
20/06/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study of addition of opioid to local anaesthetic in regional anaesthesia in cesarean section |
|
Scientific Title of Study
|
Study of epidural fentanyl 50ug with bupivacaine in cesarean section. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Leena Harshad Parate |
| Designation |
Assistant Professor;. Ex-PG student (GMC, Nagpur) |
| Affiliation |
M S Ramaiah Medical College. |
| Address |
Current address:
Department of Anaesthesia
M S Ramaiah Medical College.
Banglaore.
Original place of research work:
Government Medical College.
Nagpur
MSRIT post Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
09480525925 |
| Fax |
|
| Email |
dr_leenag@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandhya Manjrekar |
| Designation |
HOD & Professor IGMC Nagpur; EX- Professor GMC Nagpur |
| Affiliation |
Indira Gandhi Medical College |
| Address |
Current address:
Department of Anaesthesia
Indira Gandhi Medical College
Central Avenue Road
Nagpur.
Original place of research work:
Government Medical College.
Nagpur
Central Avenue Road
Nagpur.
440018
Nagpur
MAHARASHTRA
440018
India |
| Phone |
09665094398 |
| Fax |
|
| Email |
drsandhya5000@gamil.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Leena Harshad Parate |
| Designation |
Assistant Professor;. Ex-PG student (GMC, Nagpur) |
| Affiliation |
M S Ramaiah Medical College. |
| Address |
Current address:
Department of Anaesthesia
M S Ramaiah Medical College.
Banglaore
Original place of work:
Government Medical College
Nagpur
MSRIT post Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
09480525925 |
| Fax |
|
| Email |
dr_leenag@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia.
Government Medical College, Nagpur |
|
|
Primary Sponsor
|
| Name |
Government Medical College Nagpur |
| Address |
Department of Anaesthesia
Government Medical College
Near Hanuman Nagar
Nagpur. 440009 |
| 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 Leena Harshad Parate |
Department of Anaesthesia |
Government Medical College
Nagpur.
Nagpur
MAHARASHTRA |
09480525925
dr_leenag@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Medical College, Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Quality of anaesthesia and duration of postoperative analgesia in patient undergoing elective cesarean section under epidural anaesthesia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fentanyl |
Addition of 50ug fentanyl to epidural bupivacaine in patients undergoing elective cesarean section. |
| Comparator Agent |
saline / placebo |
1cc of normal saline used as placebo |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Full term patients undergoing elective cesarean section. |
|
| ExclusionCriteria |
| Details |
Foetal distress, moderate to severe PIH, Patients refusal, conversion to general anaesthsia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is intraoperative VAS score. |
Immediately after completion of surgery VAS score will be assessed. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome were the fentanyl related side effects, intraoperative haemodynamic changes, onset of analgesia, volume of drug required to achieve T6 level, quality and duration of motor block and adverse events in newborn. |
till first analgesic demand |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/07/2007 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is randomized, parallel group double blind study to study to effect of addtion of low dose fentanyl (50ug) to epidural 0.5%bupivacaine in 64 patients undergoing elective cesarean section. The primary outcome is to assess the quality of analgesia and duration of postoperative analgesia. The secondary outcome were to assess fentanyl related side effects, intraoperative haemodynamic changes, onset of analgesia, volume of drug required to achieve T6 level, quality and duration of motor block and adverse events in newborn.
|