Epidural Tap in Labor Analgesia FOR LABOR ANALGESIA

NCT ID: NCT05499234

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-10-18

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

High concentration

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

Group Type: EXPERIMENTAL

Dolantin

Intervention Type: DRUG

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

Paracetamol

Intervention Type: DRUG

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

Low concentration

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

Group Type: EXPERIMENTAL

Dolantin

Intervention Type: DRUG

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

Paracetamol

Intervention Type: DRUG

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

Interventions

Dolantin

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

Intervention Type: DRUG

Paracetamol

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

Intervention Type: DRUG

Other Intervention Names

Meperidin; Parol

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medipol University

OTHER

Sponsor Role: lead

Responsible Party

Pelin Karaaslan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pınar Uçar

Role: PRINCIPAL_INVESTIGATOR

Medipol University

Emine Uzunoğlu

Role: STUDY_CHAIR

Medipol University

Pelin Karaaslan

Role: STUDY_DIRECTOR

Medipol University

Locations

Istanbul Medipol University

Istanbul, Bağcılar, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KARAASLANP

Identifier Type: -

Identifier Source: org_study_id