Clinical trial NCT02883283: Epidural Loading Prior to Catheter Insertion
Official title: Epidural Loading Prior to Catheter Insertion: An Alternative to the Combined Spinal-epidural Technique?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Administration Methods of Labor Analgesia
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Mean VAS pain score
timeFrame: 20 minutes
Secondary outcomes:
measure: Analgesic level
timeFrame: 10, 15, and 20 minutes
measure: Maternal Blood Pressure
timeFrame: Baseline and 20 minutes
measure: Fetal Heart Rate
timeFrame: Baseline and 20 minutes
measure: Rescue Bolus Count
timeFrame: During Labor
measure: Analgesia Satisfaction
timeFrame: During labor
measure: Intravascular catheter placement
timeFrame: During labor
measure: Total anesthetic dose required
timeFrame: During Labor
measure: Maternal Heart Rate
timeFrame: Baseline and 20 minutes
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Goran Ristev, MD
role: PRINCIPAL_INVESTIGATOR
References: