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

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04234178
• Other study ID #: ATATURKLABOR
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: February 7, 2021

Study information

• Verified date: February 2022
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 7, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Labor Pain

Intervention

Drug:
• Epidural
2 µg/ml fentanyl + %0,125 bupivacaine (20 ml) to epidural
• Intrathecal+Epidural
10 µg fentanyl + 2 mg bupivacaine to intrathecal 7.4 ml saline volume to epidural

Locations

Country	Name	City	State
Turkey	Ataturk University	Erzurum	Yakutiye
Turkey	Erzurum Regional Training Research Hospital	Erzurum	Yakutiye

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

Contreras F, Morales J, Bravo D, Layera S, Jara Á, Riaño 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. pii: rapm-2019-100608. doi: 10.1136/rapm-2019-100608. [Epub ahead of print] — View Citation

Outcome

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