Epidural Loading Prior to Catheter Insertion

Administration Methods of Labor Analgesia Clinical Trial

Official title:

Epidural Loading Prior to Catheter Insertion: An Alternative to the Combined Spinal-epidural Technique?

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02883283
• Other study ID #: 2012H0314
• Status: Withdrawn
• Phase: N/A
• Start date: January 2013
• Est. completion date: January 23, 2014

Study information

• Verified date: September 2021
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study explores the potential for a more rapid onset of pain relief when drug administration is performed through the epidural needle, a technique of epidural loading that provides a rapid and reliable level of labor analgesia without the disadvantages of a combined spinal-epidural, and could add a valuable new tool to anesthesiologists.

Description:

This study explores the potential for a more rapid onset of pain relief when drug administration is performed through the epidural needle, a technique of epidural loading that provides a rapid and reliable level of labor analgesia without the disadvantages of a combined spinal-epidural, and could add a valuable new tool to anesthesiologists. Investigators propose to conduct a single blinded, randomized controlled trial to determine if a difference exists in the speed of onset and spread of labor analgesia between patients receiving an epidural loading dose through the epidural needle or catheter.

Group 1 (Epidural Catheter Administration) participants will receive the 10 mL epidural loading dose in 5 mL increments via the epidural catheter following catheter placement (current standard practice).

Group 2 (Epidural Needle Administration ) participants will receive the 10 mL epidural loading dose in 5 mL increments via the epidural needle prior to catheter placement (experimental group).

Various parameters will be measured in the time after drug administration to evaluate blood pressure, heart rate, and fetal heart rate. Following delivery, the total anesthetic dose, total number of doses demanded, total number and dosage of rescue doses, and overall patient satisfaction will be recorded.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 23, 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. subjects who have volunteered and consented to participation in the study upon admission to labor and delivery

2. parturients in active labor requesting epidural analgesia

3. uncomplicated pregnancy with a reassuring fetal heart tracing

4. age=18 years

Exclusion Criteria:

1. contraindication to epidural anesthesia

2. inability to read, comprehend, and sign the informed consent form

3. fetal intrauterine growth retardation (IUGR)

4. non-reassuring fetal heart tracing

5. cervical dilation greater than 7cm

6. intra-uterine fetal demise

7. any spinal pathology or neurologic disease

8. history of chronic pain

9. incarcerated patients

10. any patient enrolled in the study in whom there is evidence of dural puncture during epidural technique (>3 attempts, presence of CSF).

Related Conditions & MeSH terms

• Administration Methods of Labor Analgesia

Intervention

Procedure:
• Epidural loading dose
Labor epidural analgesia loading dose

Device:
• Epidural catheter
Epidural loading dose via epidural catheter
• Epidural needle
Epidural loading dose via epidural needle

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean VAS pain score	Mean VAS pain score will be determined 20 minutes following epidural loading, including assessments at 5, 10, 15, and 20 minutes.	20 minutes
Secondary	Analgesic level	Analgesic level assessed by pinprick at 10, 15 and 20 minutes following loading	10, 15, and 20 minutes
Secondary	Maternal Blood Pressure	Change in maternal blood pressure loading	Baseline and 20 minutes
Secondary	Fetal Heart Rate	Change in fetal heart rate over 20 minutes following loading	Baseline and 20 minutes
Secondary	Rescue Bolus Count	Number of rescue bolus doses will be counted	During Labor
Secondary	Analgesia Satisfaction	Overall patient satisfaction with analgesia following delivery via questionnaire	During labor
Secondary	Intravascular catheter placement	Incidence of intravascular catheter placement	During labor
Secondary	Total anesthetic dose required	The total anesthetic dose during labor will be calculated	During Labor
Secondary	Maternal Heart Rate	Change in maternal heart rate	Baseline and 20 minutes