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

• Sponsor: Ataturk University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04234178
• Collaborator: (none)
• Enrollment: 60
• Locations: 2
• Arms: 2
• Actual Duration (Months): 12.2
• Patients Per Site: 30
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Labor Pain	Drug: Epidural; Drug: Intrathecal+Epidural	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effects of Dural Puncture Epidural Versus Combined Spinal Epidural With Epidural Volume Extension Techniques on Birth Variables in Labor Analgesia
• Actual Study Start Date: Feb 1, 2020
• Actual Primary Completion Date: Feb 1, 2021
• Actual Study Completion Date: Feb 7, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. First Epidural top-up time [First 24 hours]

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

Secondary Outcome Measures

1. Sacral analgesia time [First 24 hours]

   Blockade of the S2 dermatome

2. Performance time [First 24 hours]

   interval between skin disinfection and epidural catheter fixation to the skin

3. Incidence of Side Effect [First 24 hours]

   maternal motor block, hypotension, pruritis, headache and fetal bradycardia

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ataturk University	Erzurum	Yakutiye	Turkey	25100
2	Erzurum Regional Training Research Hospital	Erzurum	Yakutiye	Turkey	25100

Sponsors and Collaborators

• Ataturk University

Investigators

• Principal Investigator: Muhammed En Aydin, Ataturk University

Study Documents (Full-Text)

None provided.

More Information

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 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]

• Responsible Party: Muhammed E Aydin, Principal Investigator, Ataturk University
• ClinicalTrials.gov Identifier: NCT04234178
• Other Study ID Numbers: ATATURKLABOR
• First Posted: Jan 21, 2020
• Last Update Posted: Feb 8, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Labor Pain

Study Results

No Results Posted as of Feb 8, 2022