| CTRI Number |
CTRI/2020/10/028645 [Registered on: 26/10/2020] Trial Registered Prospectively |
| Last Modified On: |
12/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Alpha agonists in relief of labour pain |
|
Scientific Title of Study
|
A comparison bwtween levobupivacaine with Dexmedetomidine versus levobupivacaine with clonidine in labour analgesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shruti kabi |
| Designation |
Junior resident |
| Affiliation |
King George Medical University |
| Address |
NCLRH hostel, king George medical university, lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
|
| Fax |
|
| Email |
Shruti624annie@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Singh |
| Designation |
Professor |
| Affiliation |
Department of Anesthesiology, KGMU |
| Address |
kgmu, lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
|
| Fax |
|
| Email |
dineshkgmu@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Shruti kabi |
| Designation |
Junior resident |
| Affiliation |
King George Medical University |
| Address |
Ncrlh hostel, kgmu, lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
|
| Fax |
|
| Email |
Shruti624annie@gmail.com |
|
|
Source of Monetary or Material Support
|
| King George Medical University, lucknow-226003 |
|
|
Primary Sponsor
|
| Name |
Shruti kabi |
| Address |
King george medical university, lucknow |
| 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 |
| Shruti kabi |
Queen mary hospital |
King George Medical University
Lucknow
UTTAR PRADESH |
8895624683
Shruti624annie@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, King George Medical University, Lucknow |
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 |
| Comparator Agent |
Compare dexmedetomidine and clonidine as adjuvants to levobupivacaine |
Comparision of dexmedetomidine 0.5mcg/kg and clonidine 1mcg/kg as adjuvants with levobupivacaine 0.125% with an initial bolus of 10ml followed by patient controlled bolus of 5ml and lock out period of 30 minutes |
| Intervention |
Patient controlled epidural analgesia for labour |
Comparision of dexmedetomidine and clonidine as adjuvants with levobupivacaine with an initial bolus of 10ml followed by patient controlled bolus of 5ml and lock out period of 30 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
ASA grade I,II
Full terrm
Primigravida
Singleton pregnancy with vertex presentation |
|
| ExclusionCriteria |
| Details |
Pre-eclampsia, eclampsia
Thyroid disease
Diabetes
Heart disease
Twin pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| compare Analgesic efficacy of dexmedetomidine and clonidine based on VAS score |
VAS At 0, 5, 10 15, 30, 45, 60 minutes and then every half hour until delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare motor effect by Bromage score |
At 0, 5, 10 15, 30, 45, 60 minutes and then every half hour until delivery |
| Haemodynamic effects- Heart rate, systolic BP, diastolic BP, mean arterial pressure, spo2 |
At 0, 5, 10 15, 30, 45, 60 minutes and then every half hour until delivery |
| Time of onset of analgesia, quality of analgesia, nature of Expulsive efforts, Type of delivery |
At end of delivery |
| Maternal side effects |
At end of labour |
| Neonatal outcome, Apgar score |
At 1 and 5 minutes after delivery |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
31/10/2020 |
| 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 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
|
Epidural analgesia is the most commonly used method of labour analgesia. The mainstay of use is that it provides maximum analgesia with minimum motor blockade. Of all the drugs used, bupivacaine is the most commonly used local anesthetic used. However its potential for motor blockade as made space for the use of adjuvants that help decrease the dose And concentration of local anesthetic used without any decrease in the analgesic action. The search for the ideal adjuvant has lead to the study of alpha agonists such as clodinine and dexmedetomidine. Dexmedetominde is a highly selective alpha 2 agonist that has analgesic and sedative properties. When added to local anesthetic agents it enhances their effect without increasing the side effects. It is lipophilic and hence has less propensity to cross the placenta and enter into foetal circulation. Though at present approved for iv use, it has successfully been used for epidural block and labour analgesia in clinical studies. Clonidine is also an alpha agonist that have good analgesic action. It has previously been used for labour analgesia in humans bit there has been no prior study rhat has compared the efficacy of the 2 drugs. Hence the purpose of my study is to compare the efficacy of the drugs, clonidine and dexmedetomidine when used as adjuvants for labour analegsia. |