Ultrasound Evaluation of Labor Epidural

Parturient Clinical Trial

Official title:

The Use of Ultrasound to Evaluate Precision and Analgesic Efficacy of Labor Epidural Analgesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04056403
• Other study ID #: 201907006RINC
• Status: Recruiting
• Start date: August 2019
• Est. completion date: May 2021

Study information

• Verified date: August 2019
• Source: National Taiwan University Hospital
• Contact: Chun-Yu Wu
• Phone: 0972653376
• Email: longersolo[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To compare the labor epidural analgesic (EA) profiles between landmark insertion EA levels which are congruent and ingruent to ultrasound confirmation in lateral decubitus position.

Description:

Epidural analgesia is the mainstream method for labor analgesia. Landmark identification of L3 to L5 spinous process is most commonly applied for determination of epidural insertion. However, the precision of epidural catheter insertion site was affected by physiological and anatomical variations in pregnant women and positions such as sitting or lateral decubitus. Previous study showed the clinical estimation would be ≥ 1 vertebral level higher than the anatomical position determined by ultrasound at least 40% of the time in sitting position among western pregnant women. For asian parturients, epidural analgesia is commonly performed in lateral decubitus position because of smaller stature. In addition, it remains uncertain whether the landmark epidural insertion level congruent or ingruent is associated with different analgesia profiles such as the dosage requirement and the frequncy of adjustment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 55 Years

Eligibility

Inclusion:

1. Normal spontaneous delivery parturients receiving labor epidural analgesia in first stage of labor

2. Using patient-controlled epidural analgesia

Exclusion:

1. who has an accidental epidural puncture

2. who receives epidural insertion by ultrasound identification

3. who uses of magnesium sulfate

Related Conditions & MeSH terms

• Parturient

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of landmark epidural level	Validation of landmark localization of epidural insertion level by using ultrasound examination	10 minute
Secondary	Labor analgesic dose	Influences of accurate epidural insertion level on labor epidural analgesic dose	one day