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

Not Applicable

Completed

• Conditions: Labor Pain
• Interventions: Drug: Epidural; Drug: Intrathecal+Epidural

• Registration Number: NCT04234178
• Lead Sponsor: Ataturk University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-16
• Study First Submitted QC: 2020-01-16
• Study First Posted: 2020-01-21
• Study Start: 2020-02-01
• Primary Completion: 2021-02-01
• Study Completion: 2021-02-07
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dural puncture epidural	Epidural	2 µg/ml fentanyl + %0,125 bupivacaine (20 ml) to epidural
Combined spinal-epidural with epidural volume extension	Intrathecal+Epidural	10 µg fentanyl + 2 mg bupivacaine to intrathecal 7.4 ml saline volume to epidural

Primary Outcome Measures

Name	Time	Method
First Epidural top-up time	First 24 hours	Time elapsed between the end of local anesthetic injection and the return of pain \>4 on the NPRS.

Secondary Outcome Measures

Name	Time	Method
Sacral analgesia time	First 24 hours	Blockade of the S2 dermatome
Performance time	First 24 hours	interval between skin disinfection and epidural catheter fixation to the skin
Incidence of Side Effect	First 24 hours	maternal motor block, hypotension, pruritis, headache and fetal bradycardia

Trial Locations

Locations (2)

Ataturk University; 🇹🇷 Erzurum, Yakutiye, Turkey

Erzurum Regional Training Research Hospital; 🇹🇷 Erzurum, Yakutiye, Turkey