Labor PainNCT04234178
Dural Puncture Epidural Versus Combined Spinal Epidural With Epidural Volume Extension in Labor Analgesia
A study testing Epidural and Intrathecal+Epidural in people with Labor Pain, run by Ataturk University at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- Epidural and Intrathecal+Epidural
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Feb 2020to 7 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.)
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- Substance abuse history
- Chronic pain history
- Psychiatric problems and communication difficulties
- BMI> 35 kg / m2
- Failure in neuraxial interventions
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ataturk University
Erzurum, Yakutiye, 25100
Erzurum Regional Training Research Hospital
Erzurum, Yakutiye, 25100
About this study
Official title: 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.
- Conditions
- Labor Pain
- Being tested
- Epidural, Intrathecal+Epidural
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpiduralDrug
2 µg/ml fentanyl + %0,125 bupivacaine (20 ml) to epidural
Intrathecal+EpiduralDrug
10 µg fentanyl + 2 mg bupivacaine to intrathecal 7.4 ml saline volume to epidural
| Study group | Role | What they receive |
|---|---|---|
| Dural puncture epidural | Active comparator | 2 µg/ml fentanyl + %0,125 bupivacaine (20 ml) to epidural Receives: 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 Receives: Drug: Intrathecal+Epidural |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Epidural top-up time
Time elapsed between the end of local anesthetic injection and the return of pain >4 on the NPRS.
Measured: First 24 hours
Secondary outcomes (3)
Sacral analgesia time
Blockade of the S2 dermatome
Measured: First 24 hours
Performance time
interval between skin disinfection and epidural catheter fixation to the skin
Measured: First 24 hours
Incidence of Side Effect
maternal motor block, hypotension, pruritis, headache and fetal bradycardia
Measured: First 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start1 Feb 2020
- Primary completion1 Feb 2021
- Study completion7 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed E Aydin, Ataturk University
- Investigators
- Muhammed En Aydin, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234178
- Sponsor's protocol ID
- ATATURKLABOR
- Status last verified
- Feb 2022
- First submitted
- 16 Jan 2020
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31118278Chau 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.
PubMed 28067707Doymus 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.
PubMed 40068075
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dural Puncture Epidural Versus Combined Spinal Epidural With Epidural Volume Extension Techniques on Birth Variables in Labor Analgesia
- ClinicalTrials.gov ID
- NCT04234178
- Acronym / sponsor ID
- ATATURKLABOR
- Conditions
- Labor Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 7 Feb 2021 (actual)
- First posted
- 21 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dural puncture epidural | Active comparator | Drug: Epidural2 µg/ml fentanyl + %0,125 bupivacaine (20 ml) to epidural |
| Combined spinal-epidural with epidural volume extension | Active comparator | Drug: Intrathecal+Epidural10 µg fentanyl + 2 mg bupivacaine to intrathecal 7.4 ml saline volume to epidural |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural2 µg/ml fentanyl + %0,125 bupivacaine (20 ml) to epidural | Drug | Dural puncture epidural |
| Intrathecal+Epidural10 µg fentanyl + 2 mg bupivacaine to intrathecal 7.4 ml saline volume to epidural | Drug | Combined spinal-epidural with epidural volume extension |
Primary outcome
First Epidural top-up time
Time frame: First 24 hours
Time elapsed between the end of local anesthetic injection and the return of pain >4 on the NPRS.
3 secondary outcomes
Sacral analgesia time
Time frame: First 24 hours
Performance time
Time frame: First 24 hours
Incidence of Side Effect
Time frame: First 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Background: PubMed 31118278Contreras 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.
- Background: PubMed 28067707Chau 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.
- Derived from this study: PubMed 40068075Doymus 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammed En Aydin principal investigator
Ataturk University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural and Intrathecal+Epidural in people with Labor Pain, run by Ataturk University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First Epidural top-up time (time frame: First 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04234178, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.