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

Ataturk University54 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Analgesia

Interventions

Group I: Lower Volume with Higher Anaesthetic ConcentrationPROCEDURE

10 ml of a solution containing 0,1% of bupivacaine and 2 mcg/ml fentanyl through the epidural cathether, maintained by programmed intermittant epidural (PIE) boluses of 7,5 ml of the same solution once in every hour, starting 1 hour after the loading dose. patient controlled epidural analgesia (PCEA) will be programmed so that 8 ml of the same solution with a lock-time of 10 ml may be administered

Group II: Higher Volume with LowerAnaesthetic ConcentrationPROCEDURE

20 ml of a solution containing 0,0625% of bupivacaine and 2 mcg/ml fentanyl through the epidural cathether, maintained by programmed intermittant epidural boluses of 15 ml of the same solution once in every hour, starting 1 hour after the loading dose. patient controlled epidural analgesia (PCEA) will be programmed so that 8 ml of the same solution with a lock-time of 10 ml may be administered

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Atatürk University

Erzurum, Turkey (Türkiye)

RECRUITING

Outcomes

Primary Outcomes

Difference between total local anaesthetic consumption

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.

Time frame: 5 hours or before if the labor is completed

Central Contacts

Ayşenur Dostbil

CONTACT

+905333677796 adostbil@hotmail.com

Ayşenur Dostbil

CONTACT

Data from ClinicalTrials.gov

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