Administration Methods of Labor Analgesia
Conditions
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.
Interventions
PROCEDUREEpidural loading dose
Labor epidural analgesia loading dose
DEVICEEpidural catheter
Epidural loading dose via epidural catheter
DEVICEEpidural needle
Epidural loading dose via epidural needle
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean VAS pain score | 20 minutes | Mean VAS pain score will be determined 20 minutes following epidural loading, including assessments at 5, 10, 15, and 20 minutes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Blood Pressure | Baseline and 20 minutes | Change in maternal blood pressure loading |
| Fetal Heart Rate | Baseline and 20 minutes | Change in fetal heart rate over 20 minutes following loading |
| Rescue Bolus Count | During Labor | Number of rescue bolus doses will be counted |
| Analgesic level | 10, 15, and 20 minutes | Analgesic level assessed by pinprick at 10, 15 and 20 minutes following loading |
| Intravascular catheter placement | During labor | Incidence of intravascular catheter placement |
| Total anesthetic dose required | During Labor | The total anesthetic dose during labor will be calculated |
| Maternal Heart Rate | Baseline and 20 minutes | Change in maternal heart rate |
| Analgesia Satisfaction | During labor | Overall patient satisfaction with analgesia following delivery via questionnaire |
Countries
United States
Outcome results
None listed