| CTRI Number |
CTRI/2021/07/034806 [Registered on: 13/07/2021] Trial Registered Prospectively |
| Last Modified On: |
06/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of two drugs, Fentanyl and Buprenorphine as an adjuvant to Bupivacaine in spinal anaesthesia for Lower Segment Cesarean Section |
|
Scientific Title of Study
|
Randomized double blind control trial between intrathecal Buprenorphine and intrathecal Fentanyl as an adjuvant to Bupivacaine in spinal anaesthesia for lower segment 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 PATEL NELKA MUKESHKUMAR |
| Designation |
Junior resident academic |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) medical college and research center, Pune |
| Address |
Department of Anaesthesia Bharati Vidyapeeth (Deemed to be University) medical college and research center, Dhankawadi, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
8128658765 |
| Fax |
|
| Email |
patelnelkam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr POOJA NARAYAN BHOSLE |
| Designation |
Associat Professor |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) medical college amd research center, Pune |
| Address |
Department of Anaesthesia, Bharati Vidyapeeth (Deemed to be University) medical college and research center,Dhankawadi, pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9860835279 |
| Fax |
|
| Email |
bhosle_pooja@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr POOJA NARAYAN BHOSLE |
| Designation |
Associat Professor |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) medical college amd research center, Pune |
| Address |
Department of Anaesthesia, Bharati Vidyapeeth (Deemed to be University) medical college and research center,Dhankawadi, pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9860835279 |
| Fax |
|
| Email |
bhosle_pooja@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth (Deemed to be) medical College and research center, Pune |
|
|
Primary Sponsor
|
| Name |
Bharati Vidyapeeth Deemed to be University medical college and research center |
| Address |
Bharati Vidyapeeth (Deemed to be University) Medical college and research center, pune |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrPATEL NELKA MUKESHKUMAR |
Bharati Vidyapeeth (Deemed to be) medical college and research center, Pune |
Department of Anaesthesia, Bharati Vidyapeeth medical college and research center, Pune
Pune
MAHARASHTRA |
8128658765
patelnelkam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth ( Deemed to be University) medical college, pune, institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Buprenorphine |
Inj Buprenorphine 60mcg+ Inj Bupivacaine Heavy 5% 1.8ml |
| Intervention |
Fentanyl |
Inj Fentanyl 25mcg+ Inj Bupivacaine heavy 5% 1.8ml |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
ASA II |
|
| ExclusionCriteria |
| Details |
•ASA III/IV/V
•Patients with comorbidites during pregnancy- gestational diabetes mellitus, pregnancy induce hypertension, heart disease
•Contraindications of spinal anaesthesia- raised intracranial pressure, local infection, coagulation disorders |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
•post Operative regain of sensory block and motor block
•post operative duration of first rescue analgesia demand |
Observation of motor and sensory block after spinal anaesthesia in lower segment caesarean section every 5 minutes upto 10 minutes then every 10 minutes upto end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic stability after giving spinal anaesthesia in lower segment caesarean section |
Heart rate, systolic blood pressure, diastolic blood pressure, respiratory rate, oxygen saturation for every 5 min for 10 minutes then every 10 minutes upto end of surgery |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/07/2021 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is randomized, double blind, trial Comparing the efficacy between intrathecal
buprenorphine and Fentanyl as an adjuvant to bupivacaine in spinal anaesthesia in Lower
Segment Cesarean Section for duration of sensory and motor block for surgery and duration of 1st rescue analgesia in post operative period and number of analgesic requirements in 24 hours postoperatively. |