Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
ID06602440

Observations on the Effect of Different Depths of Epidural Catheter Retention on the DPE Technique Combined With the PIEB Mode of Labor Analgesia: A Single-center, Prospective, Randomized Controlled Study

Led by General Hospital of Ningxia Medical University · Updated on 2024-09-19

102

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to observe the best depth for placing an epidural catheter during labor pain relief using a combination of dural puncture epidural (DPE) technique and programmed intermittent epidural bolus (PIEB) mode. The study focuses on shortening the time it takes for labor pain relief to start and reducing catheter-related side effects. DPE improves on previous methods by creating a pathway for medication to move from the epidural space to the subarachnoid space, potentially offering faster pain relief with fewer side effects. Participants are divided into three groups based on how far the epidural catheter is inserted: 3 centimeters, 5 centimeters, or 7 centimeters. Each group receives labor analgesia using the DPE technique combined with the PIEB mode, where medication is given in intermittent boluses to create pressure that helps the drug enter the spinal area. The study compares how the catheter depth affects the effectiveness and safety of pain relief during labor. During the study, researchers will measure the time until satisfactory pain relief is achieved and the amount of medication used from the first dose until the end of labor. They will also monitor related side effects, anesthesia levels, labor duration, and changes in fetal heart rate and uterine contractions. The study includes assessments throughout labor to ensure safety and gather detailed information on the analgesia process. Participation lasts from early labor until delivery completion.

CONDITIONS

Brief Title

Effect of Epidural Catheter Retention Depth on Labor Analgesia Performed in DPE Combined With PIEB Model

Who Can Participate

Age: 18Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 45 years old
  • Pregnancy duration of 37 to 42 weeks
  • Single healthy pregnant women with cervical dilation less than 3.0 cm
  • Uterine contraction pain with NRS score greater than 3
  • ASA physical status grade I or II
  • Body mass index (BMI) of 40 kg/m² or less
Not Eligible

You will not qualify if you...

  • Contraindications to intraspinal anesthesia
  • History of allergy to local anesthetics or opioids
  • Pregnancy-related diseases such as pregnancy-induced hypertension, preeclampsia, or gestational diabetes
  • Known fetal abnormalities or increased risk of cesarean section
  • Use of opioids or sedatives within 4 hours before epidural analgesia

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Until the end of the third stage of labor

Participants receive labor analgesia using the Dural Puncture Epidural (DPE) technique combined with Programmed Intermittent Epidural Bolus (PIEB) mode. The depth of epidural catheter retention varies among groups (3 cm, 5 cm, or 7 cm) to observe effects on analgesia.

1 labor analgesia procedure with continuous monitoring during labor

Follow-up

Duration - From labor onset to its end

Participants are monitored for anesthesia levels, motor block, labor duration, and any adverse outcomes related to the analgesia treatment until labor is completed.

Continuous monitoring during labor

Trial Site Locations

Total: 1 location

1

General hospital of Ningxia medical university

Yinchuan, Ningxia, China, 750004

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Research Team

X

xinli Ni, MD

鹏 刘

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

3

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