| CTRI Number |
CTRI/2024/05/068208 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
28/05/2024 |
| 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
|
To assess the time of onset and efficacy of sensory and motor blockade and post operative pain when two different Adjuvants are added to hyperbaric levobupivacaine for spinal anaesthesia to pregnant patients undergoing caesarean section |
|
Scientific Title of Study
|
Efficacy of Fentanyl and Butorphanol as adjuvant with 0.5% Hyperbaric Levobupivacaine in caesarean section A Randomised Controlled Double Blind Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr PITHANI VAMSEE PRIYA |
| Designation |
Post Graduate Trainee |
| Affiliation |
Kalinga Institute Of Medical Sciences |
| Address |
Department of Anaesthesiology, 3rd floor, PBMH , KIMS , KIIT University , Bhubaneswar , Khordha, Orissa
751024
India
Khordha
ORISSA
751024
India |
| Phone |
8498882244 |
| Fax |
|
| Email |
pithani1111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pramod Patra |
| Designation |
Professor |
| Affiliation |
Kalinga Institute Of Medical Sciences |
| Address |
Department of Anaesthesiology, 3rd floor, PBMH , KIMS , KIIT University , Bhubaneswar , Khordha, Orissa
751024
India
Khordha
ORISSA
751024
India |
| Phone |
9439616053 |
| Fax |
|
| Email |
pramod.patra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pramod Patra |
| Designation |
Professor |
| Affiliation |
Kalinga Institute Of Medical Sciences |
| Address |
Department of Anaesthesiology, 3rd floor, PBMH , KIMS , KIIT University , Bhubaneswar , Khordha, Orissa
751024
India
Khordha
ORISSA
751024
India |
| Phone |
9439616053 |
| Fax |
|
| Email |
pramod.patra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kalinga Institute Of Medical Sciences
Bhubaneswar
Odisha
India
751024 |
|
|
Primary Sponsor
|
| Name |
Pithani Vamsee Priya |
| Address |
Kalinga Institute Of Medical Sciences
Patia
BHUBANESWAR
Odisha
India
751024
|
| 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 |
| Pithani Vamsee Priya |
Kalinga Institute Of Medical Sciences |
Department of Anaesthesiology
3rd Floor, KIMS,
Bhubaneswar.
Khordha
ORISSA |
8498882244
2387015@kims.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE KALINGA INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: Z331||Pregnant state, incidental, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Butorphanol |
Frequency-A single dose
Dose-0.5mL(0.5mg)Butorphanol is added to 2ml of 0.5% hyperbaric Levobupivacaine
Route-Intrathecal
duration of intervention- The assessment of effects of the butorphanol with levobupivacaine will be for a duration of 6 hours from the time of injection as per different intervals mentioned in the methodology |
| Comparator Agent |
Fentanyl |
Frequency-A single dose
Dose-0.5mL(25mcg) of Fentanyl is added to 2mL of 0.5% hyperbaric Levobupivacaine
Route-Intrathecal
duration of intervention- The assessment of effects of the fentanyl with levobupivacaine will be for a duration of 6 hours from the time of injection as per different intervals mentioned in the methodology |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant females posted for LSCS under spinal anaesthesia
ASA-II |
|
| ExclusionCriteria |
| Details |
Patients not willing to be part of study
Contraindications of subarachnoid block
Allergy to local anaesthesia
Twin pregnancies
Polyhydramnios |
|
|
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 block(In seconds) |
The onset of sensory block will be assessed with a pinprick test (using a blunt 25-gauge needle along the mid-clavicular line bilaterally) every 15 seconds from time of subarachnoid block until T6 level achieved. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.2 segment regression (in minutes)
2.Duration of sensory block(in minutes)
3.Post operative analgesia(in minutes) |
1.The time taken for sensory level to regress to 2 segment below(T8) highest level(T6) will be considered as 2 segment regression for the patient. 2.Duration of sensory block defined as time taken for sensory block to regress 2 segments below from time of subarachnoid block
3.Pain will be assessed by using visual analogue scale (VAS); at 15 minutes 30 minutes and thereafter every 30 minutes till two hours postoperatively and then every hourly, till six hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="160"
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 4 |
|
Date of First Enrollment (India)
|
15/06/2024 |
| 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="2"
Months="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Since levobupivacaine is being used as a safer alternative to bupivacaine plain in spinal anesthesia for caesarean section,there are very limited studies comparing efficacy of butorphanol and fentanyl as adjuvants to levobupivacaine in caesarean section and hence this study is taken up to assess the changes in efficacy of both these opioid drugs when used as adjuvant with levobupivacaine |