Clinical trial NCT04234178: Dural Puncture Epidural Versus Combined Spinal Epidural With Epidural Volume Extension in Labor Analgesia
Official title: The Effects of Dural Puncture Epidural Versus Combined Spinal Epidural With Epidural Volume Extension Techniques on Birth Variables in Labor Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2020-01-21
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: First Epidural top-up time
timeFrame: First 24 hours
Secondary outcomes:
measure: Sacral analgesia time
timeFrame: First 24 hours
measure: Performance time
timeFrame: First 24 hours
measure: Incidence of Side Effect
timeFrame: First 24 hours
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
state: Yakutiye
city: Erzurum
country: Turkey
facility: Erzurum Regional Training Research Hospital
state: Yakutiye
Study officials:
affiliation: Ataturk University
name: Muhammed En Aydin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Contreras F, Morales J, Bravo D, Layera S, Jara A, Riano C, Pizarro R, De La Fuente N, Aliste J, Finlayson RJ, Tran DQ. Dural puncture epidural analgesia for labor: a randomized comparison between 25-gauge and 27-gauge pencil point spinal needles. Reg Anesth Pain Med. 2019 May 22:rapm-2019-100608. doi: 10.1136/rapm-2019-100608. Online ahead of print.
citation: Chau A, Bibbo C, Huang CC, Elterman KG, Cappiello EC, Robinson JN, Tsen LC. Dural Puncture Epidural Technique Improves Labor Analgesia Quality With Fewer Side Effects Compared With Epidural and Combined Spinal Epidural Techniques: A Randomized Clinical Trial. Anesth Analg. 2017 Feb;124(2):560-569. doi: 10.1213/ANE.0000000000001798.