Epidural Loading Prior to Catheter Insertion

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Administration Methods of Labor Analgesia
• Intervention / Treatment: Procedure: Epidural loading dose; Device: Epidural catheter; Device: Epidural needle

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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) Epidural loading dose via epidural catheter.	Procedure: Epidural loading dose; Labor epidural analgesia loading dose; Device: Epidural catheter; Epidural loading dose via epidural catheter
Experimental: Epidural Needle Administration; 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; Labor epidural analgesia loading dose; Device: Epidural needle; Epidural loading dose via epidural needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Goran Ristev, MD, The Ohio State University Wexner Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 23, 2014

Study Registration Dates

• First Submitted: May 9, 2016
• First Submitted That Met QC Criteria: August 24, 2016
• First Posted (Estimate): August 30, 2016

Study Record Updates

• Last Update Posted (Actual): September 27, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2012H0314

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO