| CTRI Number |
CTRI/2018/09/015778 [Registered on: 20/09/2018] Trial Registered Prospectively |
| Last Modified On: |
30/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of the effect of applying a small puncture on dura with a thin needle and proceeding to routine labor epidural with just routine labor epidural on the onset and duration of labor analgesia |
|
Scientific Title of Study
|
Effect of Dural Puncture Epidural technique on Onset and Duration of Labor Analgesia:A Randomized Control Trial |
| Trial Acronym |
DPET |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nitu PV |
| Designation |
Associate professor |
| Affiliation |
Amrita Vishwa Vidyapeetham |
| Address |
Dept of Anaesthesia, Amrita Institute of medical Sciences
Ernakulam KERALA 682041 India |
| Phone |
09495962020 |
| Fax |
2802020 |
| Email |
nituveesundeep@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Nitu PV |
| Designation |
Associate professor |
| Affiliation |
Amrita Vishwa Vidyapeetham-0 |
| Address |
Dept of Anaesthesia, Amrita Institute of medical Sciences
Ernakulam KERALA 682041 India |
| Phone |
09495962020 |
| Fax |
2802020 |
| Email |
nituveesundeep@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Nitu PV |
| Designation |
Associate professor |
| Affiliation |
Amrita Vishwa Vidyapeetham |
| Address |
Dept of Anaesthesia, Amrita Institute of medical Sciences
Ernakulam KERALA 682041 India |
| Phone |
09495962020 |
| Fax |
2802020 |
| Email |
nituveesundeep@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita institute of medical sciences,AIMSPonekkara,Kochi-682041 |
|
|
Primary Sponsor
|
| Name |
Amrita institute of medical sciencesT |
| Address |
AIMS Ponekkara,Kochi-682041 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Amrita institute of medical sciences |
AIMS Ponekkara,Kochi-682041 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nitu Puthenveettil |
Amrita institute of medical sciences |
4.0 labour room
Dept of Anaesthesia Ernakulam KERALA |
9495962020 2802020 nituveesundeep@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIMS Institutional Ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, (2) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CE GROUP |
Patients will receive 20ml of 0.1% ropivacaine with 1.5 mcg/mlfentanyl as a bolus through the epidural catheter. |
| Intervention |
DPE group |
No drugs is given through the dural puncture. 20ml of 0.1% ropivacaine with 1.5mcg/ml of fentanyl is given as a bolus through the epidural catheter. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
ASA 1 and 2 parturient in active labor |
|
| ExclusionCriteria |
| Details |
Hypersensitivity to study drugs,bleeding disorders,
decreased platelet counts, local or systemic sepsis, hypertensive disorders, pre-existing cardiac diseases, a history of drug abuse and parturient refusal. |
|
|
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 |
| Comparison of onset and duration of analgesia of dural puncture technique with conventional epidural |
delivery of baby |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the quality of analgesia, neonatal outcome and side effects |
delivery of baby |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/10/2018 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Background: Labor pain is regarded as one of the most painful events in the lifetime of women and the intensity of labour pain often exceeds the patient’s expectations. The advantages of combined spinal-epidural (CSE) technique over conventional epidural (CE) is its rapid onset, profound analgesia, high patient satisfaction and verification of epidural space by the definitive return of cerebrospinal fluid, causing a reduction in epidural catheter failures. However, the CSE technique has the potential of causing hemodynamic instability and foetal bradycardia. To reduce these side effects, dural puncture epidural (DPE) technique in which a dural hole is created without intrathecal administration of drugs is assessed. Primary Objective: Comparison of onset and duration of analgesia of DPE with CE.Secondary objectives: To compare the quality of analgesia, neonatal outcome and side effects.Design of the Study: A prospective randomized controlled double-blinded study.Sample size: We intend to conduct a pilot study with 10 patients in each group anticipating statistically significant results. Materials and Methods Inclusion Criteria: ASA 1 AND 2 patients in active labour requesting analgesia will be included in this study. Exclusion criteria: Hypersensitivity to study drugs, bleeding disorders, decreased platelet counts, local or systemic sepsis, hypertensive disorders, pre-existing cardiac diseases, a history of drug abuse and parturient refusal. Parturient with uncomplicated pregnancy in active labour will be recruited after taking informed written consent. After attaching monitors (ECG, non-invasive blood pressure, saturation probe) and securing intravenous access, baseline VAS score and vitals will be noted. All patients will be preloaded with 500ml of ringer lactate. All procedures will be performed by the same consultant anaesthetist. Post-procedural observations will be made by an anaesthetist who will be unaware of the technique followed. Patients will be randomly assigned to two groups, using a computer-generated random sequence of numbers. Group CE patients will receive conventional labour epidural using Portex epidural (Smiths Medical, Czech Republic ) and Group DPE patients will receive dural puncture epidural using Portex CSE kit with pencil point spinal 27G Whitacre needle(Smiths Medical, USA). Epidural catheter will be placed in the left lateral position either in L3-4/L4-5 space using the loss of resistance technique and catheter will be threaded cephalad 5cm into the epidural space. After negative aspiration of blood and CSF, a 20 ml dose of the study medication (20ml of 0.1% ropivacaine with 30mcg of fentanyl) will be administered in small aliquots. An additional 10 ml of study drug will be administered in case adequate analgesia (VAS ≤3) is not achieved even after 15 min. If analgesia is inadequate after 15 min of additional dose, epidural will be considered as a failure and catheter will be recited /reinserted/rescue analgesia will be provided and the patient will be withdrawn from the study. VAS score, motor blockade, heart rate and mean blood pressure will be recorded at 5 min interval up to 15 minutes and thereafter every 30 min till delivery. Foetal heart rate will be continuously monitored using a cardiotocograph. Same dose regimen will be followed as subsequent top-up dose on patient demand for pain relief. A minimum gap of 15 min will be kept between two subsequent top-up doses. VAS score will be assessed on a scale of zero (no pain) to ten (the worst imaginable pain) .Motor block in the lower extremities will be assessed by using a Breen Modified Bromage scale. Grade 1 �’ complete motor block, Grade 2 – able to move feet only, Grade 3 – just able to move knees, Grade 4 –full flexion of knees, Grade 5 – No detectable weakness of hip flexion while supine, Grade 6 – Able to perform partial knee bend. The onset of analgesia will be defined as duration from injection of first initial epidural bolus dose to the attainment of VAS ≤3 and duration of analgesia will be defined as the time of administration of the first bolus to demand of top up for the first time. Mode of delivery- normal/instrumental delivery/caesarean delivery will be noted. Injection delivery interval will be noted as the time from first initial epidural dose until the delivery. Neonatal outcome will be assessed using Apgar score at 1 and 5 min and fetal ABG. Quality of maternal expulsive efforts will be assessed by an obstetrician and graded as zero to three (Grade 0 = Failure, 1 = Incomplete, 2 = Good, 3 = Excellent). Quality of analgesia will be assessed by asking parturient to grade from zero to three (Grade 0 = Failure, Grade 1 = Incomplete, Grade 2 = Good, Grade 3 = Excellent) after delivery. The occurrence of side effects such as nausea, vomiting, hypotension, hypersensitive reaction, shivering, fever, drowsiness, pruritus, respiratory depression and retention of urine will be noted. After the collection of data, the results will be analysed statistically. |