| CTRI Number |
CTRI/2024/08/072132 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
06/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Different doses of Fentanyl with local anaesthetic low dose levobupivacaine for cesarean section |
|
Scientific Title of Study
|
Efficacy of Different Doses of Fentanyl With Intrathecal Low Dose Levobupivacaine on Recovery profile in cesarean section A Prospective Randomized Double Blind Study |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hemangini Patel |
| Designation |
Resident doctor in Department of Anaesthesiology |
| Affiliation |
Government medical college, Baroda |
| Address |
Resident doctor Department of Anaesthesia, Government Medical
College, Baroda Vadodara GUJARAT
Vadodara
GUJARAT
390001
India
Vadodara
GUJARAT
300001
India |
| Phone |
9687255344 |
| Fax |
|
| Email |
dolly5096@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Afroza N Syed |
| Designation |
Assistant Proffessor in Department of Anaesthesia |
| Affiliation |
Government medical college, Baroda |
| Address |
Assistant Professor Department of Anaesthesia, Government Medical
College, Baroda Vadodara GUJARAT
Vadodara
GUJARAT
390001
India
Vadodara
GUJARAT
390001
India |
| Phone |
9825359856 |
| Fax |
|
| Email |
afroza7887@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemangini Patel |
| Designation |
Resident doctor in Department of Anaesthesiology |
| Affiliation |
Government medical college, Baroda |
| Address |
Resident doctor Department of Anaesthesia, Government Medical
College, Baroda Vadodara GUJARAT
Vadodara
GUJARAT
390001
India
Vadodara
GUJARAT
390001
India |
| Phone |
9687255344 |
| Fax |
|
| Email |
dolly5096@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college, Baroda. Department of Anaesthesiology, SSG Hospital Vadodara, 390001. Dist- Vadodara state- Gujarat. India |
|
|
Primary Sponsor
|
| Name |
Government Medical college, Baroda |
| Address |
Department of Anaesthesiology, 2nd floor, New Surgical Block, Government medical College and SSG hospital, Vadodara |
| 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 Hemangini Patel |
SSG Hospital, vadodara |
1st floor, Rukmani Chainani Hospital, SSG hospital
Department of Obstetrics and gynaecology,
Government Medical College
Baroda, 390001 Gujarat
Vadodara
GUJARAT |
9687255344
dolly5096@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for biomedical& health research, government medical college Baroda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fentanyl 10 microgram with levobupivacaine |
After preanesthetic evaluation patients meeting inclusion criteria will be selected. Operation theatre with all necessary equipments and drugs to be kept ready. The patient will be kept in left lateral position. Patient back will be exposed and using sterile antiseptic solutions the area from inferior scapular angle to 1 cm above anal cleft will be thoroughly cleaned and covered with a sterile drape. Under all Aseptic & Antiseptic precautions, intervertebral space between L2-L3 vertebra will be identified and small skin wheal will made with 2ml of Lignocaine 2%. Spinal anaesthesia will be given in l2-l3 intervertebral space. Patients will be randomly divided into three groups. In this group 0.5 % Levobupivacaine heavy 7.5mg + Fentanyl 10microgram+ 0.3 ml Normal saline Total 2.0 ml drug given. Immediately after injecting the drug, patient will be made supine with 15degree head low tilt till the desired level achieved. Once desired level achieved which will be T4 level, table will be brought back to neutral position. Oxygen will be supplimented via facemask. Intraioperative total Duration of motor block, time for complete recovery of sensory block, duration of sensory block, 2 segment regression time, hemodynamic parameters will be assessed for 24 hours. |
| Comparator Agent |
Fentanyl 15 microgram with levobupivacaine |
After preanesthetic evaluation patients meeting inclusion criteria will be selected. Operation theatre with all necessary equipments and drugs to be kept ready. The patient will be kept in left lateral position. Patient back will be exposed and using sterile antiseptic solutions the area from inferior scapular angle to 1 cm above anal cleft will be thoroughly cleaned and covered with a sterile drape. Under all Aseptic & Antiseptic precautions, intervertebral space between L2-L3 vertebra will be identified and small skin wheal will made with 2ml of Lignocaine 2%. Spinal anaesthesia will be given in l2-l3 intervertebral space. Patients will be randomly divided into three groups. In this group 0.5% Levobupivacaine heavy 7.5mg (1.5ml) + Fentanyl 15microgram (0.3ml) +0.2ml Normal saline, Total 2.0ml drug given. Immediately after injecting the drug, patient will be made supine with 15degree head low tilt till the desired level achieved. Once desired level achieved which will be T4 level, table will be brought back to neutral position. Oxygen will be supplimented via facemask. Intraioperative total Duration of motor block, time for complete recovery of sensory block, duration of sensory block, 2 segment regression time, hemodynamic parameters will be assessed for 24 hours. |
| Comparator Agent |
Fentanyl 20 microgram with levobupivacaine |
After preanesthetic evaluation patients meeting inclusion criteria will be selected. Operation theatre with all necessary equipments and drugs to be kept ready. The patient will be kept in left lateral position. Patient back will be exposed and using sterile antiseptic solutions the area from inferior scapular angle to 1 cm above anal cleft will be thoroughly cleaned and covered with a sterile drape. Under all Aseptic & Antiseptic precautions, intervertebral space between L2-L3 vertebra will be identified and small skin wheal will made with 2ml of Lignocaine 2%. Spinal anaesthesia will be given in l2-l3 intervertebral space. Patients will be randomly divided into three groups. In this group 0.5% Levobupivacaine heavy 7.5mg (1.5ml) + Fentanyl 20 microgram (0.4ml) +0.1ml Normal saline, Total 2.0ml drug given. Immediately after injecting the drug, patient will be made supine with 15degree head low tilt till the desired level achieved. Once desired level achieved which will be T4 level, table will be brought back to neutral position. Oxygen will be supplimented via facemask. Intraioperative total Duration of motor block, time for complete recovery of sensory block, duration of sensory block, 2 segment regression time, hemodynamic parameters will be assessed for 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
ASA Grade II patients planned for cesarean section under spinal anaesthesia.
Able to understand study procedure and given consent |
|
| ExclusionCriteria |
| Details |
1. Refusal to take part in study
2. Coagulopathy/ Sickle cell disease/ Diabetes Mellitus/ Hypertensive Disorder/ Eclampsia/ Anaemia
3. Allergy or Contraindication to study drugs
4. Any contraindication to spinal anaesthesia
5. Pre-mature rupture of membrane, bleeding P/V, uterine abnormality
|
|
|
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 |
| Time for complete recovery from Motor block After giving spinal anaesthesia |
from zero minute after giving spinal anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Two segment regression time
2. Time for Complete recovery from sensory block (Duration of sensory block)
3. Time to achieve T4-T6
4. Duration of analgesia
5. Patient satisfaction score
6. Hemodynamic Parameters
7. Apgar Score in newborn
8. Any side effects like Nausea, vomiting, hypotension, tachycardia/ bradycardia, respiratory depression, pruritus, high spinal
|
Upto 24 hours |
|
|
Target Sample Size
|
Total Sample Size="285"
Sample Size from India="285"
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)
|
20/08/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The aim of study is to evaluate the effect of different doses of fentanyl with low dose levobupivacaine on recovery profile in cesarean section.
284 Pregnant women will be divided into three groups, In each group there will be 95 patient come who are posted for elective cesarean section.
In group LF 10 , 0.5% Levobupivacaine heavy 7.5 mg+ fentanyl 10 microgram(0.2 ml) + 0.3 ml Normal saline, Total 2.0 ml drug given.
In group LF 15, 0.5% Levobupivacaine heavy 7.5 mg+ fentanyl 15 microgram(0.3 ml)+ 0.2 ml Normal saline, Total 2.0 ml drug given.
In group LF 20, 0.5% Levobupivacaine heavy 7.5 mg+ fentanyl 20 microgram(0.4 ml)+ 0.2 ml Normal saline, Total 2.0 ml drug given.
Time for complete recovery from Motor block as primary outcome.
As secondary outcome two segment regression time, time for complete recovery from sensory block( Duration of sensory block), Time to achieve T4-T6, Duration of Analgesia, patient satisfaction score, hemodynamic parameters, apgar score in newborn, any side effects like nausea, vomiting, hypotension, tachycardia/ bradycardia, respiratory depression, pruritus, high spinal.
|