Overview

This trial is active, not recruiting.

Condition administration methods of labor analgesia
Treatments epidural loading dose, epidural catheter, epidural needle
Sponsor Ohio State University
Start date May 2013
End date January 2014
Trial size 60 participants
Trial identifier NCT02883283, 2012H0314

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(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.
epidural loading dose
Labor epidural analgesia loading dose
epidural catheter
Epidural loading dose via epidural catheter
(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.
epidural loading dose
Labor epidural analgesia loading dose
epidural needle
Epidural loading dose via epidural needle

Primary Outcomes

Measure
Mean VAS pain score
time frame: 20 minutes

Secondary Outcomes

Measure
Analgesic level
time frame: 10, 15, and 20 minutes
Maternal Blood Pressure
time frame: Baseline and 20 minutes
Fetal Heart Rate
time frame: Baseline and 20 minutes
Rescue Bolus Count
time frame: During Labor
Analgesia Satisfaction
time frame: During labor
Intravascular catheter placement
time frame: During labor
Total anesthetic dose required
time frame: During Labor
Maternal Heart Rate
time frame: Baseline and 20 minutes

Eligibility Criteria

Female participants at least 18 years old.

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).

Additional Information

Official title Epidural Loading Prior to Catheter Insertion: An Alternative to the Combined Spinal-epidural Technique?
Principal investigator Goran Ristev, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Ohio State University.