Epidural Loading Prior to Catheter Insertion

NCT02883283 | Withdrawn

• 1 other identifier: 2012H0314
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Administration Methods of Labor Analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Analgesic level

  10, 15, and 20 minutes

• Maternal Blood Pressure

  Baseline and 20 minutes

• Fetal Heart Rate

  Baseline and 20 minutes

• Rescue Bolus Count

  During Labor

• Analgesia Satisfaction

  During labor

Study Arms (2)

Epidural Catheter Administration

ACTIVE COMPARATOR

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.

Procedure: Epidural loading dose; Device: Epidural catheter

Epidural Needle Administration

EXPERIMENTAL

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.

Procedure: Epidural loading dose; Device: Epidural needle

Interventions

Epidural loading dose PROCEDURE

Labor epidural analgesia loading dose

Epidural Catheter Administration; Epidural Needle Administration

Epidural catheter DEVICE

Epidural loading dose via epidural catheter

Epidural Catheter Administration

Epidural needle DEVICE

Epidural loading dose via epidural needle

Epidural Needle Administration

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subjects who have volunteered and consented to participation in the study upon admission to labor and delivery
• parturients in active labor requesting epidural analgesia
• uncomplicated pregnancy with a reassuring fetal heart tracing
• age≥18 years

You may not qualify if:

• contraindication to epidural anesthesia
• inability to read, comprehend, and sign the informed consent form
• fetal intrauterine growth retardation (IUGR)
• non-reassuring fetal heart tracing
• cervical dilation greater than 7cm
• intra-uterine fetal demise
• any spinal pathology or neurologic disease
• history of chronic pain
• incarcerated patients
• any patient enrolled in the study in whom there is evidence of dural puncture during epidural technique (\>3 attempts, presence of CSF).

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Study Officials

• Goran Ristev, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor of Anesthesiology

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: August 30, 2016
• Study Start: January 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 23, 2014
• Last Updated: September 27, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)