Effect of Higher Volume and Lower Dose on Analgesic Quality During Labor Analgesia With Dural Puncture Epidural

Not Applicable

Recruiting

• Conditions: Analgesia

• Registration Number: NCT06156709
• Lead Sponsor: Ataturk University

Brief Summary

It is aimed in this study to compare the effect of using local anaesthetics in a higher volume and lower dose on the total anesthetic consumption and quality of labor analgesia with dural puncture epidural technique.

Detailed Description

This study will be conducted as a prospective randomized, controlled, double-blind trial following the approval of the ethical committee at Atatürk University Medical Faculty Hospital and after obtaining written consent from the participating patients. The study will include pregnant women aged 20 to 45 with American Society of Anesthesiologists (ASA) II classification, full-term, nulliparous and singleton pregnancies. Using a randomisation procedure, the participants will be allocated into two equal groups: Group I and Group II.

Study Timeline

• Status Verified: 2023-10
• Study Start: 2023-11-20
• Study First Submitted: 2023-11-26
• Study First Submitted QC: 2023-11-26
• Last Update Submitted: 2023-11-26
• Study First Posted: 2023-12-05
• Last Update Posted: 2023-12-05
• Primary Completion: 2025-02-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 54

Inclusion Criteria

1. Healthy nulliparous women
2. American Society of Anaesthesiology Score of II
3. During active labor
4. At weeks 37-42.
5. Singlet vertex presentation
6. Cervical dilation <5 cm at the request of labor analgesia
7. VAS score >40

Exclusion Criteria

1. Age <20 or >45,
2. Morbid obesity
3. Presence of pregnancy-related comorbidities (e.g: gestational diebetes, gestational hypertension and preeclampsia)
4. History of drug abuse
5. Contrindication for neuraxial blocks
6. Conditions that increase the risk of need for cesarean section (e.g. placenta previa, uterus abnormalities or surgeries)
7. Diagnosed fetal abnormalities
8. Cases where dura gets punctured unintendedly with the epiduralneedle
9. Cases where flow of cerebrospinal fluid (CSF) is not observed after dural puncture
10. Cases where a cesarean section is performed at any stage of labor
11. Cases where labor is completed in 1 hour from the start of analgesia procedure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Difference between total local anaesthetic consumption	5 hours or before if the labor is completed	The study will involve monitoring the patients starting 2 minutes after the initial epidural dose, every 2 minutes during the first 20 minutes. Monitoring will continue at the 30th minute, and once in every 90 minutes for 5 hours or until labor is completed.; Total bupivacain consumption will be calculated as follows: PIEB + PCEA + boluses by the clinician. Bupivacain consumption per hour will be calculated.

Trial Locations

Locations (1)

Atatürk University; 🇹🇷 Erzurum, Turkey