Epidural Loading Prior to Catheter Insertion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-01-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Epidural Loading: High Volume, Low Concentration

NCT02803450

Labor and Delivery

WITHDRAWN NA

SKIN WHEAL - Subcutaneous or Intradermal Lidocaine in Epidural for Laboring Pain.

NCT06236126

Analgesia, Obstetrical

RECRUITING NA

Effect of Epidural Needle Injection on Catheter Placement Success During Painless Labour

NCT07327918

Labour Analgesia

NOT_YET_RECRUITING PHASE3

Optimal Regimen of Patient-controlled Epidural Analgesia in Laboring Patients

NCT03566342

LABOR PAIN

TERMINATED

Comparative Study of the Loading Dose Administrated Via Epidural Needle or Epidural Catheter for Labor Analgesia

NCT05594771

Labor Pain

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Administration Methods of Labor Analgesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Epidural loading dose

Intervention Type PROCEDURE

Labor epidural analgesia loading dose

Epidural catheter

Intervention Type DEVICE

Epidural loading dose via epidural catheter

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.

Group Type EXPERIMENTAL

Epidural loading dose

Intervention Type PROCEDURE

Labor epidural analgesia loading dose

Epidural needle

Intervention Type DEVICE

Epidural loading dose via epidural needle

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Epidural loading dose

Labor epidural analgesia loading dose

Intervention Type PROCEDURE

Epidural catheter

Epidural loading dose via epidural catheter

Intervention Type DEVICE

Epidural needle

Epidural loading dose via epidural needle

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes