Epidural Loading: High Volume, Low Concentration

Not Applicable

Withdrawn

• Conditions: Labor and Delivery

• Registration Number: NCT02803450
• Lead Sponsor: Ohio State University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-06-14
• Study First Submitted QC: 2016-06-16
• Study First Posted: 2016-06-17
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-21
• Last Update Posted: 2021-09-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Patient Pain Levels (VAS Assessment)	During Labor	Patients will be assessed for pain levels on the VAS scale after analgesia administration in both arms
Patient Satisfaction	During labor	Patient satisfaction with analgesia using a Likert rating of patient satisfaction with anesthetic care.

Secondary Outcome Measures

Name	Time	Method
Analgesic level	20 minutes	Pinprick every 10, 15, and 20 minutes following loading
Maternal Vital Signs	20 minutes	Measure change in maternal blood pressure and heart rate over 20 minutes following loading.
Fetal Heart Rate	20 minutes	Measure change in fetal heart rate following loading.
Rescue Bolus	During Labor	Measure number of rescue bolus doses and total anesthetic dose
Intravascular Catheter Placement	During labor	Measure incidence of intravascular catheter placement.

Trial Locations

Locations (1)

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States