Epidural Loading Prior to Catheter Insertion

The Ohio State University

Status: Withdrawn

Conditions: Administration Methods of Labor Analgesia

Treatments: Procedure: Epidural loading dose; Device: Epidural needle; Device: Epidural catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT02883283

2012H0314

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Epidural Catheter Administration

Active Comparator group

Description:

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.

Treatment:

Procedure: Epidural loading dose

Device: Epidural catheter

Epidural Needle Administration

Experimental group

Description:

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.

Treatment:

Procedure: Epidural loading dose

Device: Epidural needle