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

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.

Study Overview

• Status: Completed
• Conditions: Labor Pain
• Intervention / Treatment: Drug: Epidural; Drug: Intrathecal+Epidural

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Yakutiye
    • Erzurum, Yakutiye, Turkey, 25100
      • Ataturk University
    • Erzurum, Yakutiye, Turkey, 25100
      • Erzurum Regional Training Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dural puncture epidural; 2 µg/ml fentanyl + %0,125 bupivacaine (20 ml) to epidural	Drug: Epidural; 2 µg/ml fentanyl + %0,125 bupivacaine (20 ml) to epidural
Active Comparator: Combined spinal-epidural with epidural volume extension; 10 µg fentanyl + 2 mg bupivacaine to intrathecal 7.4 ml saline volume to epidural	Drug: Intrathecal+Epidural; 10 µg fentanyl + 2 mg bupivacaine to intrathecal 7.4 ml saline volume to epidural

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ataturk University
• Investigators: Principal Investigator: Muhammed En Aydin, Ataturk University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): February 7, 2021

Study Registration Dates

• First Submitted: January 16, 2020
• First Submitted That Met QC Criteria: January 16, 2020
• First Posted (Actual): January 21, 2020

Study Record Updates

• Last Update Posted (Actual): February 8, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: ATATURKLABOR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No