Epidural Tap in Labor Analgesia FOR LABOR ANALGESIA

NCT05499234 | Completed DMC

• 1 other identifier: KARAASLANP
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Labor Pain

Keywords

labor analgesia; dural tap; concentration

Outcome Measures

Primary Outcomes (1)

• 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

  In an hour

Secondary Outcomes (1)

• Complication comparison

  2 days

Study Arms (2)

High concentration

EXPERIMENTAL

Epidural analgesia with 20 mL of 0.125% bupivacaine + 2 mcg/mL fentanyl solution

Drug: Dolantin; Drug: Paracetamol

Low concentration

EXPERIMENTAL

Epidural analgesia with 20 mL of 0.0625% bupivacaine + 2 mcg/mL fentanyl solution

Drug: Dolantin; Drug: Paracetamol

Interventions

Dolantin DRUG

If VAS score is more than 4 even after additional dose, use dolantin 1 mg/kg

Also known as: Meperidin

High concentration; Low concentration

Paracetamol DRUG

If VAS score is more than 4 even after dolantin 1 mg/kg, 10 mg/kg paracetamol IV

Also known as: Parol

High concentration; Low concentration

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA II primigravid women
• with cervical dilatation between 4-6 cm, demanding epidural analgesia during spontaneous vaginal delivery

You may not qualify if:

• Participants with pregnancy-related diseases
• gestational hypertension
• gestational diabetes
• preeclampsia/ celmpsia
• contraindications for neuraxial block
• infection
• coagulation disorders
• severe hypovolemia
• sepsis
• neurological deficit
• cardiac valve stenosis or hypertrophic obstructive cardiomyopathy
• Women with fetal malpresentation and fetal anomaly

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Bağcılar, 34700, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 41299385 DERIVED

MeSH Terms

Conditions

Labor Pain

Interventions

Meperidine; Acetaminophen

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Isonipecotic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Pınar Uçar

  Medipol University

  PRINCIPAL INVESTIGATOR

• Emine Uzunoğlu

  Medipol University

  STUDY CHAIR

• Pelin Karaaslan

  Medipol University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants and the medical staff administrating epidural drugs will not be told about the concentration. Because volumes will be same, they would not predict which group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 70 ASA II primigravid women with cervical dilatation between 4-6 cm and demanding epidural analgesia during spontaneous vaginal delivery

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 12, 2022
• Study Start: August 1, 2022
• Primary Completion: October 18, 2023
• Study Completion: October 18, 2023
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

TU (1)