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

NCT04234178 | Completed

• 1 other identifier: ATATURKLABOR
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Labor Pain

Outcome Measures

Primary Outcomes (1)

• First Epidural top-up time

  Time elapsed between the end of local anesthetic injection and the return of pain \>4 on the NPRS.

  First 24 hours

Secondary Outcomes (3)

• Sacral analgesia time

  First 24 hours

• Performance time

  First 24 hours

• Incidence of Side Effect

  First 24 hours

Study Arms (2)

Dural puncture epidural

ACTIVE COMPARATOR

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

Drug: Epidural

Combined spinal-epidural with epidural volume extension

ACTIVE COMPARATOR

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

Drug: Intrathecal+Epidural

Interventions

Epidural DRUG

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

Dural puncture epidural

Intrathecal+Epidural DRUG

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

Combined spinal-epidural with epidural volume extension

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (2)

Ataturk University

Erzurum, Yakutiye, 25100, Turkey (Türkiye)

Location

Erzurum Regional Training Research Hospital

Erzurum, Yakutiye, 25100, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 31118278 BACKGROUND

• 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.

  PMID: 28067707 BACKGROUND

• Doymus O, Aydin ME, Bedir Z, Tor IH, Ejder Tekgunduz S, Doymus G, Celik EC, Ahiskalioglu A. Epidural volume extension versus dural puncture epidural analgesia for labor: A prospective randomized study. Medicine (Baltimore). 2025 Mar 7;104(10):e41691. doi: 10.1097/MD.0000000000041691.

  PMID: 40068075 DERIVED

MeSH Terms

Conditions

Labor Pain

Interventions

Injections, Epidural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Muhammed En Aydin

  Ataturk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 21, 2020
• Study Start: February 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 7, 2021
• Last Updated: February 8, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)