Labor PainNCT05499234
Epidural Tap in Labor Analgesia FOR LABOR ANALGESIA
A study testing Dolantin and Paracetamol in people with Labor Pain, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
The dural epidural tap method is performed by creating a dural perforation with a spinal needle placed through epidural needle, followed by placement of a catheter into the epidural space. No medications are administered through spinal needle. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- Dolantin and Paracetamol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 18 Oct 2023
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA II primigravid women
- with cervical dilatation between 4-6 cm, demanding epidural analgesia during spontaneous vaginal delivery
Who cannot join
- Participants with pregnancy-related diseases
- gestational hypertension
- gestational diabetes
- preeclampsia/ celmpsia
- contraindications for neuraxial block
- infection
Show all 12Show fewer
- coagulation disorders
- severe hypovolemia
- sepsis
- neurological deficit
- cardiac valve stenosis or hypertrophic obstructive cardiomyopathy
- Women with fetal malpresentation and fetal anomaly
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Bağcılar, 34700
About this study
Official title: Effects of Different Local Anesthetic Concentrations With Epidural Tap Method for Labor Analgesia
The dural epidural tap method is performed by creating a dural perforation with a spinal needle placed through epidural needle, followed by placement of a catheter into the epidural space. No medications are administered through spinal needle. This prospective, randomized study includes 70 ASA II primigravid women with cervical dilatation between 4-6 cm and demanding epidural analgesia during spontaneous vaginal delivery.In the first group, 20 mL of 0.125% bupivacaine + 2 mcg/mL fentanyl solution and in the second group, 20 mL of 0.0625% bupivacaine + 2 mcg/mL fentanyl solution was administered as the first dose through the epidural catheter. Then, the visual analog scale (VAS) score was aimed to be below 4 in both groups.
Read the detailed description
This prospective, randomized study includes 70 ASA II primigravid women with cervical dilatation between 4-6 cm and demanding epidural analgesia during spontaneous vaginal delivery. Participants with pregnancy-related diseases (such as gestational hypertension, gestational diabetes, preeclampsia) and contraindications for neuraxial block (infection, coagulation disorder, severe hypovolemia, sepsis, neurological deficit, cardiac valve stenosis or hypertrophic obstructive cardiomyopathy) will be excluded from the study. Women with fetal malpresentation and fetal anomaly will also be excluded.
Participants will randomly be divided into 2 equal groups. Immediately before epidural placement, subjects will be marked a VAS score during an active contraction. All subjects will have an intravenous catheter placed and be monitored with NST, noninvasive blood pressure and pulse oximetry.
The epidural space will be identified by a loss of resistance technique to saline. CSF flow will be observed at L3-L4 or L4-L5 level by puncturing the dura with a 27 G needle before inserting the epidural catheter. A combined spinal epidural set with 18 G Tuohy needle will be used in both groups. In the first group, 20 mL of 0.125% bupivacaine + 2 mcg/mL fentanyl solution and in the second group, 20 mL of 0.0625% bupivacaine + 2 mcg/mL fentanyl solution will be administered as the first dose through the epidural catheter. Then, the visual analog scale (VAS) score will be aimed to be below 4 in both groups. Patients with a VAS score of 4 or higher 15 minutes after the first dose received, an additional 10 mL dose of the same solution will be given. An additional 10 mL dose also will be administered when the VAS score is 4 or higher until crowning.
Before the epidural catheter placed; age, weight, height, blood pressure of the participants, gestational week, use of oxytocin during delivery, cervical dilatation amount before the procedure and fetal heart rate will be recorded. After each dose of administration, whether maternal hypotension, fetal bradycardia, pruritus, nausea-vomiting or motor block development will be monitored. The total amount of drug administered through the epidural catheter, the time between applications, and the number of bolus doses administered will also be recorded.
- Conditions
- Labor Pain
- Being tested
- Dolantin, Paracetamol
- Keywords
- labor analgesia, dural tap, concentration
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DolantinDrug
Also called Meperidin
If VAS score is more than 4 even after additional dose, use dolantin 1 mg/kg
ParacetamolDrug
Also called Parol
If VAS score is more than 4 even after dolantin 1 mg/kg, 10 mg/kg paracetamol IV
| Study group | Role | What they receive |
|---|---|---|
| High concentration | Experimental | Epidural analgesia with 20 mL of 0.125% bupivacaine + 2 mcg/mL fentanyl solution Receives: Drug: Dolantin; Drug: Paracetamol |
| Low concentration | Experimental | Epidural analgesia with 20 mL of 0.0625% bupivacaine + 2 mcg/mL fentanyl solution Receives: Drug: Dolantin; Drug: Paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change the need of bupivacaine for epidural analgesia.
primary aim of this study is to achieve Numeric Pain Rating Scale scores equal to or below 4 via different bupivacaine concentrations. More than 4 is bad and unacceptable
Measured: In an hour
Secondary outcomes (1)
Complication comparison
measure the number of treatment related complications and compare these measurements between the groups.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start1 Aug 2022
- Primary completion18 Oct 2023
- Study completion18 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Medipol 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 70 ASA II primigravid women with cervical dilatation between 4-6 cm and demanding epidural analgesia during spontaneous vaginal delivery
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pelin Karaaslan, Medipol University
- Investigators
- Pınar Uçar, Principal investigator, Medipol UniversityEmine Uzunoğlu, Study chair, Medipol UniversityPelin Karaaslan, Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499234
- Sponsor's protocol ID
- KARAASLANP
- Status last verified
- Feb 2024
- First submitted
- 2 Aug 2022
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ucar FP, Danisan HG, Omur B, Alici HA, Karaaslan P. Effects of different bupivacaine concentrations with dural puncture epidural technique for labor analgesia: a prospective randomized controlled trial. BMC Anesthesiol. 2025 Nov 26;25(1):590. doi: 10.1186/s12871-025-03486-0.
PubMed 41299385
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Local Anesthetic Concentrations With Epidural Tap Method for Labor Analgesia
- ClinicalTrials.gov ID
- NCT05499234
- Acronym / sponsor ID
- KARAASLANP
- Conditions
- Labor Pain
- Keywords
- labor analgesia, dural tap, concentration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 18 Oct 2023 (actual)
- Study completion
- 18 Oct 2023 (actual)
- First posted
- 12 Aug 2022 (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.
The dural epidural tap method is performed by creating a dural perforation with a spinal needle placed through epidural needle, followed by placement of a catheter into the epidural space. No medications are administered through spinal needle. This prospective, randomized study includes 70 ASA II primigravid women with cervical dilatation between 4-6 cm and demanding epidural analgesia during spontaneous vaginal delivery.In the first group, 20 mL of 0.125% bupivacaine + 2 mcg/mL fentanyl solution and in the second group, 20 mL of 0.0625% bupivacaine + 2 mcg/mL fentanyl solution was administered as the first dose through the epidural catheter. Then, the visual analog scale (VAS) score was aimed to be below 4 in both groups.
Detailed description
This prospective, randomized study includes 70 ASA II primigravid women with cervical dilatation between 4-6 cm and demanding epidural analgesia during spontaneous vaginal delivery. Participants with pregnancy-related diseases (such as gestational hypertension, gestational diabetes, preeclampsia) and contraindications for neuraxial block (infection, coagulation disorder, severe hypovolemia, sepsis, neurological deficit, cardiac valve stenosis or hypertrophic obstructive cardiomyopathy) will be excluded from the study. Women with fetal malpresentation and fetal anomaly will also be excluded.
Participants will randomly be divided into 2 equal groups. Immediately before epidural placement, subjects will be marked a VAS score during an active contraction. All subjects will have an intravenous catheter placed and be monitored with NST, noninvasive blood pressure and pulse oximetry.
The epidural space will be identified by a loss of resistance technique to saline. CSF flow will be observed at L3-L4 or L4-L5 level by puncturing the dura with a 27 G needle before inserting the epidural catheter. A combined spinal epidural set with 18 G Tuohy needle will be used in both groups. In the first group, 20 mL of 0.125% bupivacaine + 2 mcg/mL fentanyl solution and in the second group, 20 mL of 0.0625% bupivacaine + 2 mcg/mL fentanyl solution will be administered as the first dose through the epidural catheter. Then, the visual analog scale (VAS) score will be aimed to be below 4 in both groups. Patients with a VAS score of 4 or higher 15 minutes after the first dose received, an additional 10 mL dose of the same solution will be given. An additional 10 mL dose also will be administered when the VAS score is 4 or higher until crowning.
Before the epidural catheter placed; age, weight, height, blood pressure of the participants, gestational week, use of oxytocin during delivery, cervical dilatation amount before the procedure and fetal heart rate will be recorded. After each dose of administration, whether maternal hypotension, fetal bradycardia, pruritus, nausea-vomiting or motor block development will be monitored. The total amount of drug administered through the epidural catheter, the time between applications, and the number of bolus doses administered will also be recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 70 ASA II primigravid women with cervical dilatation between 4-6 cm and demanding epidural analgesia during spontaneous vaginal delivery
| Arm | Type | Receives |
|---|---|---|
| High concentration | Experimental | Drug: Dolantin, Drug: ParacetamolEpidural analgesia with 20 mL of 0.125% bupivacaine + 2 mcg/mL fentanyl solution |
| Low concentration | Experimental | Drug: Dolantin, Drug: ParacetamolEpidural analgesia with 20 mL of 0.0625% bupivacaine + 2 mcg/mL fentanyl solution |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA II primigravid women
- with cervical dilatation between 4-6 cm, demanding epidural analgesia during spontaneous vaginal delivery
Key exclusion criteria (12 listed)
- Participants with pregnancy-related diseases
- contraindications for neuraxial block
- Women with fetal malpresentation and fetal anomaly
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 |
|---|---|---|
| DolantinAlso: MeperidinIf VAS score is more than 4 even after additional dose, use dolantin 1 mg/kg | Drug | High concentration, Low concentration |
| ParacetamolAlso: ParolIf VAS score is more than 4 even after dolantin 1 mg/kg, 10 mg/kg paracetamol IV | Drug | High concentration, Low concentration |
Primary outcome
Change the need of bupivacaine for epidural analgesia.
Time frame: In an hour
primary aim of this study is to achieve Numeric Pain Rating Scale scores equal to or below 4 via different bupivacaine concentrations. More than 4 is bad and unacceptable
1 secondary outcome
Complication comparison
Time frame: 2 days
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 1 Mar 2024.
- Derived from this study: PubMed 41299385Ucar FP, Danisan HG, Omur B, Alici HA, Karaaslan P. Effects of different bupivacaine concentrations with dural puncture epidural technique for labor analgesia: a prospective randomized controlled trial. BMC Anesthesiol. 2025 Nov 26;25(1):590. doi: 10.1186/s12871-025-03486-0.
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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.
Pınar Uçar principal investigator
Medipol University
Emine Uzunoğlu study chair
Medipol University
Pelin Karaaslan study director
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dolantin and Paracetamol in people with Labor Pain, run by Medipol University at 1 site 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 2 inclusion and 12 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 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change the need of bupivacaine for epidural analgesia. (time frame: In an hour). 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 NCT05499234, which also lists 1 linked publication.
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 1 Mar 2024.