| CTRI Number |
CTRI/2017/08/009399 [Registered on: 17/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
16/08/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs, nalbuphine and fentanyl in patients undergoing caesarean section. |
|
Scientific Title of Study
|
To compare the effect of intrathecal nalbuphine and fentanyl as adjuvants to bupivacaine in caesarean 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 Garima Jindal |
| Designation |
PG Anaesthesiology |
| Affiliation |
Government Medical college patiala |
| Address |
House No 9, street no 1, Punjabi bagh, circular road, nabha
Patiala
PUNJAB
147201
India |
| Phone |
9646486062 |
| Fax |
|
| Email |
garimajindal90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tripat Kaur Bindra |
| Designation |
Associate Professor |
| Affiliation |
GMC Patiala |
| Address |
Dept of Anesthesiology and Intensive care, GMC Patiala
Patiala
PUNJAB
147001
India |
| Phone |
9501017040 |
| Fax |
|
| Email |
tripat_noori@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tripat Kaur Bindra |
| Designation |
Associate Professor |
| Affiliation |
GMC Patiala |
| Address |
Dept of Anesthesiology and Intensive care, GMC Patiala
Patiala
PUNJAB
147001
India |
| Phone |
9501017040 |
| Fax |
|
| Email |
tripat_noori@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
Government Medical college patiala |
| 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 Garima Jindal |
Government Medical college patiala |
Dept of Anaesthesiology and Dept. of obstetrics and gynaecology
Patiala
PUNJAB |
9646486062
garimajindal90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Term Pregnant females undergoing caesarean section, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
fentanyl |
20ug intrathecally as an adjuvant to bupivacaine |
| Intervention |
intrathecal fentanyl vs nalbuphine as an adjuvant to bupivacaine in caesarean section |
fentanyl 20ug
nalbuphine 0.8mg |
| Comparator Agent |
nalbuphine |
0.8mg intrathecally as an adjuvant to bupivacaine |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Term Pregnant females with ASA Grade I,II |
|
| ExclusionCriteria |
| Details |
1.Patient’s refusal
2.Any spine abnormality
3.Altered coagulation profile
4.Allergy to local anaesthetic
5.Recent myocardial infarction
6.Significant aortic stenosis
Patients with neurological disorders
Cardiac or respiratory system failure
Any major hepatic or renal problem
|
|
|
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 |
Sensory blockade
Motor blockade
VAS
|
Sensory blockade: continuously​ till onset then every 10 minutes​ till regression
Motor blockade at 5,10,15 minutes then every 10minutes till regression
3.VAS: every 15 minutes in the first hour then hourly for 4 hours then at 12hours and 24 hours after spinal blockade
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Sedation scale
Complications
Vitals
|
Intraoperative |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
12/12/2016 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/12/2016 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To prolong the duration of postoperative analgesia in caesarean section by adding adjuvants to bupivacaine in spinal blockade |