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

The Effects of Dural Puncture Epidural Versus Combined Spinal Epidural With Epidural Volume Extension Techniques on Birth Variables in Labor Analgesia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04234178
Enrollment
60
Registered
2020-01-21
Start date
2020-02-01
Completion date
2021-02-07
Last updated
2022-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Pain

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.

Interventions

DRUGIntrathecal+Epidural

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

DRUGEpidural

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

Sponsors

Ataturk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
First Epidural top-up timeFirst 24 hoursTime elapsed between the end of local anesthetic injection and the return of pain \>4 on the NPRS.

Secondary

MeasureTime frameDescription
Sacral analgesia timeFirst 24 hoursBlockade of the S2 dermatome
Performance timeFirst 24 hoursinterval between skin disinfection and epidural catheter fixation to the skin
Incidence of Side EffectFirst 24 hoursmaternal motor block, hypotension, pruritis, headache and fetal bradycardia

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026