| CTRI Number |
CTRI/2019/06/019917 [Registered on: 27/06/2019] Trial Registered Prospectively |
| Last Modified On: |
26/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Benefits of using two different local anaesthetics, bupivacaine and ropivacaine with fentanyl for pain relief in labouring parturients |
|
Scientific Title of Study
|
Fentanyl as an adjuvant to Bupivacaine and Ropivacaine in Epidural labour Analgesia- An Observational Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sofiya Memon |
| Designation |
PG Resident |
| Affiliation |
Pt J N M Medical College, Raipur |
| Address |
Department of Anaesthesiology, Pt J N M Medical College, Raipur, Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
8109299668 |
| Fax |
|
| Email |
sofiyamemon786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jaya Lalwani |
| Designation |
Professor |
| Affiliation |
Pt J N M Medical College, Raipur |
| Address |
Department of Anaesthesiology, Pt J N M Medical College, Raipur, Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
9300224989 |
| Fax |
|
| Email |
jayalalwani2020@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jaya Lalwani |
| Designation |
Professor |
| Affiliation |
Pt J N M Medical College, Raipur |
| Address |
Department of Anaesthesiology, Pt J N M Medical College, Raipur, Chhattisgarh
CHHATTISGARH
492001
India |
| Phone |
9300224989 |
| Fax |
|
| Email |
jayalalwani2020@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Bhimrao Ambedkar Memorial Hospital, mekahara, Jail road, Raipur, Chhattisgarh (491001) |
|
|
Primary Sponsor
|
| Name |
Dr Sofiya Memon |
| Address |
Department of Anaesthesiology, Pt. J.N.M. Medical College, Raipur (C.G.) |
| Type of Sponsor |
Other [PG resident student conducting this study] |
|
|
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 Sofiya Memon |
Dr Bhimrao Ambedkar Memorial Hospital & Pt J N M Medical College, Raipur |
Department of Anaesthesiology and Critical Care, Raipur, Chhattisgarh
Raipur
CHHATTISGARH |
8109299668
sofiyamemon786@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 |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Epidural labour analgesia |
Effect of Bupivacaine(0.125%) with fentanyl(1 mcg/ml) compared to Ropivacaine(0.125%) with fentanyl(1 mcg/ml) for labour pain relief via lumbar epidural. The first test dose is given as bolus 5 ml followed by further 5 ml increments untill Visual analog scale is less than 3. The subsequent doses are also given similarly as bolus. Patient to be followed upto 2 hours after delivery. |
| Comparator Agent |
Epidural labour Analgesia |
Effect of Bupivacaine(0.125%) with fentanyl(1 mcg/ml) compared to Ropivacaine(0.125%) with fentanyl(1 mcg/ml) for labour pain relief via lumbar epidural. The first test dose is given as bolus 5 ml followed by further 5 ml increments untill Visual analog scale is less than 3. The subsequent doses are also given similarly as bolus. Patient to be followed upto 2 hours after delivery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. ASA Physical status II
2. Singleton Pregnancy
3. Term Pregnancy
4. Vertex presentation
5. Request for Neuraxial Analgesia |
|
| ExclusionCriteria |
| Details |
1. Parturients who had cervical dilatation >5 cm
2. Patients who had received Parentral opioids <2 hour earlier
3. Parturients with Obstetric complication such as Pre eclampsia, Eclampsia, multiple pregnancies, macrosomia, diabetes, heart disease, cephalopelvic disproportion,
Malpresentation
3. Coagulation defect
4. Vertebral anomaly
5. Local sepsis
6. Sensitivity to drug- Bupivacaine and Ropivacaine
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of Analgesia |
from Onset of analgesia which is Vas less than 3 to request for additional Analgesia considered when patient feels contraction is uncomfortable. VAS is accessed every 5 minutes untill VAS is less than 3. than every 15 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Highest level of sensory block, Side effects, Mode of Delivery, Maximum Motor Block, Haemodynamic Changes i.e., Heart rate, Mean blood pressure, sPO2. |
at 5, 10, 15, 30, 60 min then every 60 min |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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
|
N/A |
|
Date of First Enrollment (India)
|
06/07/2019 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Labour analgesia with use of epidural local anaesthetics and opioids is routinely used technique for pain relief in labour. My study compares the effect of two different local anaesthetics Bupivacaine and Ropivacaine when used with same amount of low dose opioid fentanyl. Such study camparing effects of same concentration [0.125%] of two different local anaesthetics have not been done previously in our institute and will help in determining the benefits if any of one local anaesthetic over another. |