| CTRI Number |
CTRI/2023/06/053707 [Registered on: 09/06/2023] Trial Registered Prospectively |
| Last Modified On: |
08/06/2023 |
| 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 Study to Compare the Efficacy And Safety Of Different Adjuncts To Local Anaesthetic For Labor Pain |
|
Scientific Title of Study
|
A Randomised Clinical Trial To Compare The Efficacy And Safety Of Dexmedetomidine-Ropivacaine Versus Fentanyl-Ropivacaine For Epidural Labor Analgesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RESHMA R S |
| Designation |
Junior Resident in Anaesthesiology |
| Affiliation |
Shri B M Patil Medical College |
| Address |
Department of Anaesthesiology, Shri B M Patil Medical College, Bangaramma Sajjan Campus, Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
9496381213 |
| Fax |
|
| Email |
reshmarajs001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SHIVANAND L K |
| Designation |
Associate Professor, Department of Anaesthesiology |
| Affiliation |
Shri B M Patil Medical College |
| Address |
Department of Anaesthesiology, Shri B M Patil Medical College, Bangaramma Sajjan Campus, Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
9164319345 |
| Fax |
|
| Email |
shivanandkarigar82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RESHMA R S |
| Designation |
Junior Resident in Anaesthesiology |
| Affiliation |
Shri B M Patil Medical College |
| Address |
Department of Anaesthesiology, Shri B M Patil Medical College, Bangaramma Sajjan Campus, Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
9496381213 |
| Fax |
|
| Email |
reshmarajs001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri B M Patil Medical College, BLDE university, Bangaramma Sajjan Campus, Vijayapura, Karnataka- 586103 |
|
|
Primary Sponsor
|
| Name |
Shri B M Patil Medical College |
| Address |
BLDE University, Bangaramma Sajjan Campus, Vijayapura, Karnataka- 586103 |
| Type of Sponsor |
Private 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 |
| Reshma R S |
Shri B M Patil Medical College |
Shri B M Patil Medical College, BLDE University, Bangaramma Sajjan Campus, Vijayapura
Bijapur
KARNATAKA |
9496381213
reshmarajs001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Shri B M Patil Medical College, BLDE University |
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 |
injection Dexmedetomidine IV |
Group RD will be receiving Intravenous Dexmedetomidine used as adjuvant to local anaesthetics 0.1% Ropivacaine. Dose of dexmedetomidine is 0.5mcg/ml of 0.1% Ropivacaine.Initial Bolus dose of 10ml of 0.1% Ropivacaine with Dexmedetomidine 0.5mcg/ml is given immediately after epidural catheter insertion followed by infusion at the rate of 7 ml/hr till delivery. Rescue doses of 7 ml of 0.1%Inj. Ropivacaine with 0.5 mcg/ml Dexmedetomidine with lockout period of 25 minutes given when required. |
| Comparator Agent |
Injection Fentanyl IV |
Group RF will be receiving Intravenous Fentanyl used as adjuvant to local anaesthetics 0.1% Ropivacaine. Dose of Fentanyl is 2 mcg/ml of 0.1% Ropivacaine.Initial bolus dose of 10 ml of 0.1% Ropivacaine with Fentanyl 2 mcg/ml given immediately after epidural catheter insertion followed by infusion at the rate of 7ml/hr till delivery. Rescue doses of 7ml of 0.1% Inj. Ropivacaine with 2 mcg/ml Fentanyl with lockout period of 25 minutes given when required. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Primigravida with cephalic presentation
ASA grade I and II
Maternal age 19 to 35 years
Term gestation more than or equal to 37 weeks
Single fetus
Cervical dilatation more than or equal to 4 cm |
|
| ExclusionCriteria |
| Details |
Hypotension/ Hypertension
Obesity
Endocrine disorders
Fetal compromise
Preterm gestation
Coagulopathies
Allergy to study agents
Contraindications to epidural analgesia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare Dexmedetomidine and Fentanyl as adjuvants in epidural analgesia in terms of:
The onset of epidural analgesia, duration of analgesia, rescue analgesic dose
Visual Analog Scale(VAS)
Maternal Vitals- Heart rate, Blood Pressure, Oxygen saturation |
Cervical dilatation from more than or equal to 4 cm to time of delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Ramsay Sedation Score
APGAR score of the baby
Maternal side effects- pruritis, hypotension, nausea, vomiting, shivering, respiratory depression, bradycradia |
Time of Epidural analgesia to time of delivery of baby |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
21/06/2023 |
| 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)
|
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)?
Response - NO
|
|
Brief Summary
|
This study is a Randomized,Parallel Group study. This study consists of 2 groups where Group RD who will receive 0.1% Inj.Ropivacaine + 0.5mcg/ml Inj.Dexmedetomidine and Group RF who will receive 0.1% Inj. Ropivacaine +2 mcg/ml Inj. Fentanyl. 68 Primigravida in labor will be equally divided into these 2 groups of 34 each. This study will be conducted in Shri. B M Patil Medical College, Vijayapura, Karnataka, India. The primary outcome is to compare Dexmedetomidine and Fentanyl as adjuvants in epidural analgesia in terms of the onset of epidural analgesia, duration of analgesia, rescue analgesic dose, Visual Analog Scale, maternal vitals such as heart rate, blood pressure, oxygen saturation. The secondary outcome is to observe Ramsay Sedation Scale of mother, APGAR score of baby and maternal side effects like pruritis, hypotension, nausea, vomiting, shivering, respiratory depression, bradycardia. |