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

Ataturk University

Status: Completed

Conditions: Labor Pain

Treatments: Drug: Intrathecal+Epidural; Drug: Epidural

Study type: Interventional

Funder types: Other

Identifiers

NCT04234178

ATATURKLABOR

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Dural puncture epidural

Active Comparator group

Description:

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

Treatment:

Drug: Epidural

Combined spinal-epidural with epidural volume extension

Active Comparator group

Description:

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

Treatment:

Drug: Intrathecal+Epidural