Epidural Loading Prior to Catheter Insertion

Not Applicable

Withdrawn

• Conditions: Administration Methods of Labor Analgesia
• Interventions: Procedure: Epidural loading dose; Device: Epidural catheter; Device: Epidural needle

• Registration Number: NCT02883283
• Lead Sponsor: Ohio State University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2014-01
• Study Completion: 2014-01-23
• Study First Submitted: 2016-05-09
• Study First Submitted QC: 2016-08-24
• Study First Posted: 2016-08-30
• 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• Status: WITHDRAWN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≥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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidural Catheter Administration	Epidural loading dose	Participants will receive the 10 mL epidural loading dose in 5 mL increments via the epidural catheter following catheter placement. (Current standard practice) Epidural loading dose via epidural catheter.
Epidural Catheter Administration	Epidural catheter	Participants will receive the 10 mL epidural loading dose in 5 mL increments via the epidural catheter following catheter placement. (Current standard practice) Epidural loading dose via epidural catheter.
Epidural Needle Administration	Epidural loading dose	Participants will receive the 10 mL epidural loading dose in 5 mL increments via the epidural needle prior to catheter placement. Epidural loading dose via epidural needle.
Epidural Needle Administration	Epidural needle	Participants will receive the 10 mL epidural loading dose in 5 mL increments via the epidural needle prior to catheter placement. Epidural loading dose via epidural needle.

Primary Outcome Measures

Name	Time	Method
Mean VAS pain score	20 minutes	Mean VAS pain score will be determined 20 minutes following epidural loading, including assessments at 5, 10, 15, and 20 minutes.

Secondary Outcome Measures

Name	Time	Method
Maternal Heart Rate	Baseline and 20 minutes	Change in maternal heart rate
Rescue Bolus Count	During Labor	Number of rescue bolus doses will be counted
Intravascular catheter placement	During labor	Incidence of intravascular catheter placement
Analgesic level	10, 15, and 20 minutes	Analgesic level assessed by pinprick at 10, 15 and 20 minutes following loading
Maternal Blood Pressure	Baseline and 20 minutes	Change in maternal blood pressure loading
Fetal Heart Rate	Baseline and 20 minutes	Change in fetal heart rate over 20 minutes following loading
Analgesia Satisfaction	During labor	Overall patient satisfaction with analgesia following delivery via questionnaire
Total anesthetic dose required	During Labor	The total anesthetic dose during labor will be calculated

Trial Locations

Locations (1)

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