Back to results

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

Primary Purpose

Labor Pain

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Epidural

Intrathecal+Epidural

About this trial

This is an interventional treatment trial for Labor Pain

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Ataturk University
Erzurum Regional Training Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Dural puncture epidural

Combined spinal-epidural with epidural volume extension

Arm Description

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

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

Outcomes

Primary Outcome Measures

First Epidural top-up time

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

Secondary Outcome Measures

Sacral analgesia time

Blockade of the S2 dermatome

Performance time

interval between skin disinfection and epidural catheter fixation to the skin

Incidence of Side Effect

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

Full Information

NCT ID

NCT04234178

First Posted

January 16, 2020

Last Updated

February 7, 2022

Sponsor

Ataturk University

1. Study Identification

Unique Protocol Identification Number

NCT04234178

Brief Title

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

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

February 1, 2020 (Actual)

Primary Completion Date

February 1, 2021 (Actual)

Study Completion Date

February 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Labor Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dural puncture epidural

Arm Type

Active Comparator

Arm Description

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

Arm Title

Combined spinal-epidural with epidural volume extension

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Epidural

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Intrathecal+Epidural

Intervention Description

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

Primary Outcome Measure Information:

Title

First Epidural top-up time

Description

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

Time Frame

First 24 hours

Secondary Outcome Measure Information:

Title

Sacral analgesia time

Description

Blockade of the S2 dermatome

Time Frame

First 24 hours

Title

Performance time

Description

interval between skin disinfection and epidural catheter fixation to the skin

Time Frame

First 24 hours

Title

Incidence of Side Effect

Description

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

Time Frame

First 24 hours

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Pregnant patients

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Muhammed En Aydin

Organizational Affiliation

Ataturk University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ataturk University

City

Erzurum

State/Province

Yakutiye

ZIP/Postal Code

25100

Country

Turkey

Facility Name

Erzurum Regional Training Research Hospital

City

Erzurum

State/Province

Yakutiye

ZIP/Postal Code

25100

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31118278

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.

Results Reference

background

PubMed Identifier

28067707

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.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs