| CTRI Number |
CTRI/2020/08/027060 [Registered on: 10/08/2020] Trial Registered Prospectively |
| Last Modified On: |
06/08/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pain relief for child birth by epidural anaesthesia |
|
Scientific Title of Study
|
Comparison of dural-puncture epidural (DPE) and epidural analgesia (EA)for labor-a prospective randomized double blind 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 Ashok Jadon |
| Designation |
Chief Medical Superintendent |
| Affiliation |
Tata Motors Hospital |
| Address |
Department of Anaesthesia, First floor OT complex, Tata Motors Hospital, Jamshedpur
Purbi Singhbhum
JHARKHAND
831004
India |
| Phone |
06576695676 |
| Fax |
|
| Email |
ashok.jadon@tatamotors.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Jadon |
| Designation |
Chief Medical Superintendent |
| Affiliation |
Tata Motors Hospital |
| Address |
Department of Anaesthesia, First floor OT complex, Tata Motors Hospital, Jamshedpur
JHARKHAND
831004
India |
| Phone |
06576695676 |
| Fax |
|
| Email |
ashok.jadon@tatamotors.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Jadon |
| Designation |
Chief Medical Superintendent |
| Affiliation |
Tata Motors Hospital |
| Address |
Department of Anaesthesia, First floor OT complex, Tata Motors Hospital, Jamshedpur
JHARKHAND
831004
India |
| Phone |
06576695676 |
| Fax |
|
| Email |
ashok.jadon@tatamotors.com |
|
|
Source of Monetary or Material Support
|
| Tata Motors Hospital, Jamshedpur |
|
|
Primary Sponsor
|
| Name |
Dr Ashok Jadon |
| Address |
Duplex-63, Vijaya Heritage-6, Kadma, Jamshedpur |
| 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 |
| Dr Ashok Jadon |
Tata Motors Hospital |
Department of Anesthesia & Pain Relief service,
1st floor OT complex, Tata Motors Hospital, Jamshedpur
Purbi Singhbhum
JHARKHAND |
06576695676
ashok.jadon@tatamotors.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee, Tata Motors Hospital |
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 |
Dural-puncture epidural(DPE) |
While providing epidural analgesia for labor, intentional dural puncture is done with spinal needle however,no drug is administered. Afterwards, an epidural catheter is inserted and labor analgesia is achieved by infusion of local anesthetic.This facilitates early onset of pain relief. |
| Comparator Agent |
Epidural analgesia (EA) |
This is a conventional method where epidural catheter is inserted without dural-puncture and pain relief is achieved by infusion of local anesthetic through epidural catheter. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Who has give the consent for labor epidural analgesia.
|
|
| ExclusionCriteria |
| Details |
1. Refusal to give consent.
2. Contraindication for spinal or epidural
3. History of drug allergy to local anesthetics.
4. Severe systemic disease related to respiratory, cardiovascular, central nervous system.
4. Psychiatric disorder and migraine. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Onset of analgesia eg. 50% reduction in (VAS)visual analogue score.
2. Time taken to achieve VAS of 3 |
1.Baseline
2. Every 5minutes for 30 minutes.
3. Every hr for 12 hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Out come of labor.
2.Incidence of motor block.
3.Incidence of paresthesia.
4.Total bupivacaine and fentanyl used.
5. VAS score
6. APGAR score |
1hourly |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
14/08/2020 |
| 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="0"
Months="3"
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 (EA) is the gold standard for pain relief during labor. Many new techniques have been incorporated with EA to make it more effective like addition of various adjuvants, practice of spinal epidural technique and dural puncture epidural technique (DPE). DPE is relatively new technique where intentional dural puncture with spinal needle is done before insertion of epidural catheter while EA is being done. The proposed advantages are early onset of pain relief and better efficacy. We regularly use EA for labor analgesia. We want to compare this new approach with our standard EA technique. Patients who are willing after informed consent for epidural analgesia for labor pain relief will be divided in two equal groups by random table. After explaining the visual analogue scale score (VAS score), with due aseptic precautions and with standard vital monitoring 18G tuohy epidural needle will be placed at L3-L4 level under local anaesthesia to locate epidural space by loss of saline. Afterwards, 27G Whitacre spinal needle will be inserted through epidural needle. In DPE group intentional dural puncture will be attempted (confirmed by CSF back -flow) while in EA group, needle will only be inserted for 1-2cm (sham puncture). After removal of spinal needle, epidural catheter will be inserted and needle will be removed. The marking of catheter at skin will be calculated to keep catheter 3-5cm in the epidural space. After negative aspiration test, 3ml 0.125% bupivacaine will be given through catheter. After waiting for 3 minutes if no sign of spinal anaesthesia or accidental intravascular injection is noted, 9ml of same local anesthetic will be injected with repeated aspiration test over 2 minutes. Catheter will be fixed and dressed with transparent dressing. Then an infusion of 0.8% bupivacaine and fentanyl 2microgram/ml will be given by infusion pump @10ml/hr. VAS score will be recorded every 2 minutes till it comes down to 3. Time to 50% reduction in VAS from base line value and time to achieve VAS 3 will be recorded. VAS will be monitored every hr till the delivery. Breakthrough pain will be managed by 5ml bolus of 0.125% bupivacaine every 15 minutes till VAS comes to 3. All the data about duration of labor, total dose of bupivacaine and fentanyl used, VAS scores, outcome of labor and APGAR of newborn will be recorded and analysed by appropriate statistical tools for analysis. |