Clinical trial

Effects of Different Local Anesthetic Concentrations With Epidural Tap Method for Labor Analgesia

Name

KARAASLANP

Description

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.

Trial arms

Trial start

2022-08-01

Estimated PCD

2023-10-18

Trial end

2023-10-18

Status

Completed

Treatment

Dolantin

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

Arms:

High concentration, Low concentration

Other names:

Meperidin

Paracetamol

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

Arms:

High concentration, Low concentration

Other names:

Parol

Size

Primary endpoint

Change the need of bupivacaine for epidural analgesia.

In an hour

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '70 ASA II primigravid women with cervical dilatation between 4-6 cm and demanding epidural analgesia during spontaneous vaginal delivery', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 70, 'type': 'ACTUAL'}}

Updated at

2024-03-01

1 organization

2 products

1 indication

Organization

Product

Indication

Product