Epidural Tap in Labor Analgesia FOR LABOR ANALGESIA

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.

Study Overview

• Status: Completed
• Conditions: Labor Pain
• Intervention / Treatment: Drug: Dolantin; Drug: Paracetamol

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bağcılar
    • Istanbul, Bağcılar, Turkey, 34700
      • İstanbul Medipol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High concentration; Epidural analgesia with 20 mL of 0.125% bupivacaine + 2 mcg/mL fentanyl solution	Drug: Dolantin; If VAS score is more than 4 even after additional dose, use dolantin 1 mg/kg; Other Names: Meperidin; Drug: Paracetamol; If VAS score is more than 4 even after dolantin 1 mg/kg, 10 mg/kg paracetamol IV; Other Names: Parol
Experimental: Low concentration; Epidural analgesia with 20 mL of 0.0625% bupivacaine + 2 mcg/mL fentanyl solution	Drug: Dolantin; If VAS score is more than 4 even after additional dose, use dolantin 1 mg/kg; Other Names: Meperidin; Drug: Paracetamol; If VAS score is more than 4 even after dolantin 1 mg/kg, 10 mg/kg paracetamol IV; Other Names: Parol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication comparison	measure the number of treatment related complications and compare these measurements between the groups.	2 days

Collaborators and Investigators

• Sponsor: Medipol University
• Investigators: Principal Investigator: Pınar Uçar, Medipol University; Study Chair: Emine Uzunoğlu, Medipol University; Study Director: Pelin Karaaslan, Medipol University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): October 18, 2023
• Study Completion (Actual): October 18, 2023

Study Registration Dates

• First Submitted: August 2, 2022
• First Submitted That Met QC Criteria: August 10, 2022
• First Posted (Actual): August 12, 2022

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: concentration; labor analgesia; dural tap
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Acetaminophen; Meperidine
• Other Study ID Numbers: KARAASLANP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No