| CTRI Number |
CTRI/2019/01/017099 [Registered on: 16/01/2019] Trial Registered Prospectively |
| Last Modified On: |
08/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of two drugs ropivacaine and levobupivacaine in labor pain relief by dural puncture epidural technique |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of ropivacaine and levobupivacaine in labor analgesia by dural puncture epidural technique- A prospective double-blinded randomized trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jyotsna Punj |
| Designation |
Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES,NEW DELHI |
| Address |
Department of Anaesthesiology, Pain Medicine & Critical Care
Room No-5013, 5th floor
Teaching Block, AIIMS,
Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9810191116 |
| Fax |
|
| Email |
jyotsna_punj@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyotsna Punj |
| Designation |
Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES,NEW DELHI |
| Address |
Department of Anaesthesiology, Pain Medicine & Critical Care
Room No-5013, 5th floor
Teaching Block, AIIMS,
Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9810191116 |
| Fax |
|
| Email |
jyotsna_punj@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kathiravan T |
| Designation |
Junior resident |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES,NEW DELHI |
| Address |
Department of Anaesthesiology, Pain Medicine & Critical Care
Room No-5011, 5th floor
Teaching Block, AIIMS,
Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9486649488 |
| Fax |
|
| Email |
kathiravan4763@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Pain Medicine & Critical Care
Room No-5013, 5th floor
Teaching Block, AIIMS,
Ansari Nagar, New Delhi-110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Jyotsna Punj |
All india institute of medical sciences |
Room No-5011, 5th floor
Teaching Block, AIIMS,
Ansari Nagar, New Delhi-110029
New Delhi
DELHI |
9810191116
jyotsna_punj@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institute ethics committee, AIIMS |
Approved |
| INSTITUTE ETHICS COMMITTEE,AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Levobupivacaine |
20 ml of 0.125% levobupivacaine and 2mcg/ml of fentanyl given by dural puncture epidural technique |
| Intervention |
Ropivacaine |
20 ml of 0.125% ropivacaine and 2mcg/ml of fentanyl given by dural puncture epidural technique
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. ASA I and ASA II parturient having single fetus in vertex presentation
2. Patients in active labor with cervical dilatation <5.0 cm
3. Patients desiring labor analgesia
|
|
| ExclusionCriteria |
| Details |
1. Patients refusal to participate
2. Patients with diseases of pregnancy such as gestational hypertension, preeclampsia, gestational diabetes mellitus
3. Patients in whom neuraxial procedures are contraindicated
4. Patients having fetus with anomalies
5. Patients who are at high chance for cesarean delivery such as cephalopelvic disproportion, previous cesarean section
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time of onset to NPRS score ≤ 1 |
0.5,2,4,6,8,10,12,14,16,18,20 and 30 minutes, then every 90 minutes until delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Symmetry of blockade
2. Maternal adverse effects such as pruritus, hypotension, uterine tachysystole and hypertonus
3. Time to delivery
4. Mode of delivery
5. Fetal outcomes by APGAR
6. Number of boluses by PCEA
7. Number of physician top-up interventions |
0.5,2,4,6,8,10,12,14,16,18,20 and 30 minutes, then every 90 minutes until delivery |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
17/01/2019 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Randomization of included study subjects into two groups( Group R and Group L) The DPE will be performed by following steps under aseptic precautions; patient in sitting position, identify L2-L3/L3-L4 intervertebral space, inject lignocaine 2% for local infiltration. Then 16-G Tuohy needle will be inserted in intervertebral space and identify epidural space by loss of resistance to saline technique. 26-G Whitacre spinal needle inserted through epidural needle and create dural hole. The creation of dural hole will be confirmed by free-flow of CSF. The spinal needle will be withdrawn without giving any drug in the subarachnoid space. 18-G Epidural catheter will be inserted in the epidural space. The drugs will be given only through the epidural catheter. Initial dosing consists of maximum of 20 ml of 0.125% ropivacaine with fentanyl 2µg/ml in group R and maximum of 20ml of 0.125% levobupivacaine with fentanyl 2µg/ml in group L. In both groups it will be fractionated into four 5 ml boluses given over 5 minutes. After initial dosing PCEA will be started. A blinded anaesthesiologist will come after initial bolus dose and assess outcomes. The entry of blinded anaesthesiologist will be designated as time 0(t=0). The outcomes will be assessed at t=0.5,2,4,6,8,10,12,14,16,18,20 and 30 minutes, then every 90 minutes until delivery. The following outcomes will be assessed 1. Analgesia by NPRS score 2. Sensory blockade 3. Motor blockade by modified Bromage scale 4. Asymmetric blockade 5. Maternal hypotension 6. Fetal bradycardia 7. Abnormal uterine contractions We hypothesized that ropivacaine would produce better analgesia and lower motor blockade than levobupivacaine |