Dural Puncture Epidural Versus Combined Spinal Epidural With Epidural Volume Extension in Labor Analgesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2021-02-07

Brief Summary

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Labor is the process where the cervix is prepared to allow the baby to pass from the uterine cavity to the outside world. In the ordinary course, it ends with spontaneous or instrumental vaginal delivery or cesarean section. Traditionally, the first stage in which the cervix is passively dilated in response to uterine contractions consists of the second stage in which the mother passes the baby through the vagina and the third stage, the exit of the placenta.

In the first stage of labor, pain is caused by uterine contractions and pressure on the cervix. Pain is transmitted through the T10-L2 spinal nerves and is felt in the abdominal wall, waist, hips, or thighs. In the second stage, pain from the vagina and perineum is added to uterine pain. This pain is transmitted by the pudendal nerves through the S2-4 nerve roots.

In this study, we aimed to investigate the effects of dural puncture epidural analgesia versus combined spinal-epidural analgesia with epidural volume extension on labor variables.

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Detailed Description

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Conditions

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Labor Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dural puncture epidural

2 µg/ml fentanyl + %0,125 bupivacaine (20 ml) to epidural

Group Type ACTIVE_COMPARATOR

Epidural

Intervention Type DRUG

2 µg/ml fentanyl + %0,125 bupivacaine (20 ml) to epidural

Combined spinal-epidural with epidural volume extension

10 µg fentanyl + 2 mg bupivacaine to intrathecal 7.4 ml saline volume to epidural

Group Type ACTIVE_COMPARATOR

Intrathecal+Epidural

Intervention Type DRUG

10 µg fentanyl + 2 mg bupivacaine to intrathecal 7.4 ml saline volume to epidural

Interventions

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Epidural

2 µg/ml fentanyl + %0,125 bupivacaine (20 ml) to epidural

Intervention Type DRUG

Intrathecal+Epidural

10 µg fentanyl + 2 mg bupivacaine to intrathecal 7.4 ml saline volume to epidural

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ASA I and II parturients
* Pregnant patients in active labor
* active labor with cervical dilation \< 5cm
* 37-42 weeks of gestational age
* Pregnant women between the ages of 18 and 45

Exclusion Criteria

* Patients who do not want to participate voluntarily in the study
* Pregnant women outside the age range of 18 - 45
* Pregnants other than Nullipar
* Patients with allergic reactions to anesthesia and analgesia drugs to be used
* Severe systemic disease (kidney, liver, pulmonary, endocrine, cardiac)
* Gestational comorbidity (preeclampsia, eclampsia, diabetes mellitus, etc.)
* Substance abuse history
* Chronic pain history
* Psychiatric problems and communication difficulties
* BMI\> 35 kg / m2
* Failure in neuraxial interventions

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No