MedPath

A clinical trial to study the effect of two drugs ropivacaine and levobupivacaine in labor pain relief by dural puncture epidural technique

Phase 4
Conditions
Health Condition 1: O00-O9A- Pregnancy, childbirth and the puerperium
Registration Number
CTRI/2019/01/017099
Lead Sponsor
All India Institute of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Time of onset to NPRS score â?¤ 1Timepoint: 0.5,2,4,6,8,10,12,14,16,18,20 and 30 minutes, then every 90 minutes until delivery
Secondary Outcome Measures
NameTimeMethod
1. Symmetry of blockade <br/ ><br>2. Maternal adverse effects such as pruritus, hypotension, uterine tachysystole and hypertonus <br/ ><br>3. Time to delivery <br/ ><br>4. Mode of delivery <br/ ><br>5. Fetal outcomes by APGAR <br/ ><br>6. Number of boluses by PCEA <br/ ><br>7. Number of physician top-up interventionsTimepoint: 0.5,2,4,6,8,10,12,14,16,18,20 and 30 minutes, then every 90 minutes until delivery
© Copyright 2025. All Rights Reserved by MedPath