Epidural Loading: High Volume, Low Concentration

Labor and Delivery Clinical Trial

Official title:

Epidural Loading With High Volume, Low Concentration Prior to Catheter Insertion: is How You Administer the Volume Important?

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02803450
• Other study ID #: 2013H0188
• Status: Withdrawn
• Phase: N/A
• Start date: February 2016
• Est. completion date: January 2017

Study information

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

Clinical Trial Summary

This prospective, randomized, single blinded control trial will investigate the effects of epidural loading with a high volume, low concentration local anesthetic solution via the epidural needle versus the epidural catheter.

Description:

This prospective, randomized, single blinded control trial will investigate the effects of epidural loading with a high volume, low concentration local anesthetic solution via the epidural needle versus the epidural catheter. Control patients will receive local anesthetic in lower volume more concentrated solution via the epidural catheter which is current standard practice. Outcome measures will include quantifying pain relief with respect to time using VAS scores. In addition, post delivery patient satisfaction regarding anesthesia regimen, blood pressure changes, heart rate, anesthetic level, total dose of epidural used during labor, rescue doses and incidence of fetal bradycardia will be assessed. 35 patients will be recruited for each of the three arms of the study, totaling 105 patients, in order to obtain significance when performing statistical analyses following complete enrollment in the study. The impetus of this study involves investigation of the effects of loading the epidural space with high volume, low concentration local anesthetic via two different modalities and studying which method is more efficacious.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 89 Years

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 greater than or equal to 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. History of chronic pain other than in the back

8. Incarcerated patients I. Any patient enrolled in the study in whom there is evidence of dural puncture during epidural technique (>3 attempts, presence of CSF)

j. Any evidence of high spinal after initial bolus or continuous infusion of high volume, low concentration local anesthetic solution k. Women undergoing cesarean section

Related Conditions & MeSH terms

• Labor and Delivery

Intervention

Procedure:
• Epidural needle
Medication administration via epidural needle.
• Catheter Administration
Medication administration via epidural catheter.
• Standard of Care Epidural Administration
Medication administered at higher concentration, lower volume via epidural catheter.

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	Patient Pain Levels (VAS Assessment)	Patients will be assessed for pain levels on the VAS scale after analgesia administration in both arms	During Labor
Primary	Patient Satisfaction	Patient satisfaction with analgesia using a Likert rating of patient satisfaction with anesthetic care.	During labor
Secondary	Analgesic level	Pinprick every 10, 15, and 20 minutes following loading	20 minutes
Secondary	Maternal Vital Signs	Measure change in maternal blood pressure and heart rate over 20 minutes following loading.	20 minutes
Secondary	Fetal Heart Rate	Measure change in fetal heart rate following loading.	20 minutes
Secondary	Rescue Bolus	Measure number of rescue bolus doses and total anesthetic dose	During Labor
Secondary	Intravascular Catheter Placement	Measure incidence of intravascular catheter placement.	During labor