| CTRI Number |
CTRI/2018/12/016739 [Registered on: 19/12/2018] Trial Registered Prospectively |
| Last Modified On: |
12/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical tiral to compare the effects of two drugs, Fentanyl and Nalbuphine when added in Spinal anaesthesia for patients undergoing cesarean section. |
|
Scientific Title of Study
|
Comparison of efficacy of intrathecal nalbuphine vs fentanyl as adjuvant to subarachnoid block 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 |
SHANMUGAVALLI E |
| Designation |
Assistant professor |
| Affiliation |
Velammal Medical College Hospital and Research Institute,Madurai. |
| Address |
Department of anaesthesiology, Aarupadai Veedu Medical College and Hospital,Pondicherry.
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9940882722 |
| Fax |
|
| Email |
Vallijegan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RAMADEVI P |
| Designation |
Assistant professor |
| Affiliation |
Velammal medical college and research institute |
| Address |
Department of anaesthesiology,Velammal Medical College and Research Institute ,Madurai.
Madurai
TAMIL NADU
625009
India |
| Phone |
8695752109 |
| Fax |
|
| Email |
rama_rathi86@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
RAMADEVI P |
| Designation |
Assistant professor |
| Affiliation |
Velammal medical college and research institute |
| Address |
Department of Anaesthesiology,Velammal Medical College and Research Institute ,Madurai.
Madurai
TAMIL NADU
625009
India |
| Phone |
8695752109 |
| Fax |
|
| Email |
rama_rathi86@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SHANMUGAVALLI E |
| Address |
Department of Anaesthesiology,Aarupadai Veedu Medical College and Hospital,Madurai. |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrRamadevi |
Velammal medical college and research institute |
Department of anaesthesia,
Velammalmedicalcollege and research institute
Madurai-625009.
Madurai
TAMIL NADU |
8695752109
rama_rathi86@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| VELAMMAL MEDICAL COLLEGE HOSPITAL AND RESEARH INSTITUE,INSTITUTIONAL ETHICS COMMITTEE |
Approved |
| VELAMMAL MEDICAL COLLEGE HOSPITAL AND RESEARH INSTITUE,INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94-O9A||Other obstetric conditions, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intrathecal fentanyl 25 mcg |
Subarachnoid block for cesarean section.
Group 1 will receive inj. Nalbuphine 0.8 mg along with inj.buphivacaine 0.5 %heavy 10 mg total volume 2.5 ml.
Group 2 will receive inj.fentanyl 25 mcg along with inj.buphivacaine heavy 0.5%heavy 10 mg total volume of 2.5 ml .the analgesic effect and efficacy of intrathecal nalbuphine will be compared with intrathecal fentanyl. Patient will be observed for five hours. Subarachnoid block will be given once only. |
| Intervention |
Subarachnoid block in cesarean section |
Subarachnoid block for cesarean section wil be given.
Group 1 will receive inj.nalbuphine 0.8 mg along with inj.buphivacaine 0.5%heavy 10 mg total volume 2.5 ml
Group 2 will receive inj.fentanyl 25 mcg along with inj.buphivacaine 0.5%heavy 10 mg total volume 2.5 ml.Patient will be monitored for five hours. Subarachnoid block will be given only once. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
ASA Physical statusII
Weight between 50 to 80 kilogram
Height between 150 to 160 cm
Cesarean section |
|
| ExclusionCriteria |
| Details |
ASA Physical status III,IV and V.patients receiving long term analgesic therapy,hypnotics or long term CNS depressants.Peripheral neuropathy.cogulopathy,infction at the site of injection.cardiac,hepatic or renal diseases. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Analgesic effect.
Onset time of sensry blockade.
Onset time of motor blockade.
Highest level of sensory blockade.
Two segment regression time.
Duration of effective analgesia.
Duration of motor blockade.
Ramsay sedation score in te post operative period. |
Analgesic effect.
Onset time of sensry blockade.
Onset time of motor blockade.
Highest level of sensory blockade.
Two segment regression time.
Duration of effective analgesia.
Duration of motor blockade.All these parameters will be monitored at 0 mins,2mins,5mins,10mins,15mins,30mins,45mins,60mins,90mins,120mins,150mins,180mins,210mins,240mins,270mins and 300mins.
Ramsay sedation score in te post operative period will be documented. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intra operative parameters heart rate
Systolic blood pressure
Diastolic blood pressure
Respiratory rate
Hypotension
Bradycardia
Respiratory depression are monitored |
6 hrs |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
25/12/2018 |
| 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="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized double blind controlled study to compare the efficacy and analgesic effect of intrathecal nalbuphine versus fentanyl as adjuvant to subarachnoid block in cesarean section |