Labor and Delivery
Conditions
Keywords
Effects of; Anesthesia, spinal and epidural
Brief summary
This prospective, randomized, single blinded control trial will investigate the effects of epidural loading with a high volume, low concentration local anesthetic solution via the epidural needle versus the epidural catheter.
Detailed description
This prospective, randomized, single blinded control trial will investigate the effects of epidural loading with a high volume, low concentration local anesthetic solution via the epidural needle versus the epidural catheter. Control patients will receive local anesthetic in lower volume more concentrated solution via the epidural catheter which is current standard practice. Outcome measures will include quantifying pain relief with respect to time using VAS scores. In addition, post delivery patient satisfaction regarding anesthesia regimen, blood pressure changes, heart rate, anesthetic level, total dose of epidural used during labor, rescue doses and incidence of fetal bradycardia will be assessed. 35 patients will be recruited for each of the three arms of the study, totaling 105 patients, in order to obtain significance when performing statistical analyses following complete enrollment in the study. The impetus of this study involves investigation of the effects of loading the epidural space with high volume, low concentration local anesthetic via two different modalities and studying which method is more efficacious.
Interventions
PROCEDUREEpidural needle
Medication administration via epidural needle.
PROCEDURECatheter Administration
Medication administration via epidural catheter.
PROCEDUREStandard of Care Epidural Administration
Medication administered at higher concentration, lower volume via epidural catheter.
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 89 Years
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 greater than or equal to 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. History of chronic pain other than in the back 8. Incarcerated patients I. Any patient enrolled in the study in whom there is evidence of dural puncture during epidural technique (\>3 attempts, presence of CSF) j. Any evidence of high spinal after initial bolus or continuous infusion of high volume, low concentration local anesthetic solution k. Women undergoing cesarean section
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Pain Levels (VAS Assessment) | During Labor | Patients will be assessed for pain levels on the VAS scale after analgesia administration in both arms |
| Patient Satisfaction | During labor | Patient satisfaction with analgesia using a Likert rating of patient satisfaction with anesthetic care. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fetal Heart Rate | 20 minutes | Measure change in fetal heart rate following loading. |
| Analgesic level | 20 minutes | Pinprick every 10, 15, and 20 minutes following loading |
| Intravascular Catheter Placement | During labor | Measure incidence of intravascular catheter placement. |
| Rescue Bolus | During Labor | Measure number of rescue bolus doses and total anesthetic dose |
| Maternal Vital Signs | 20 minutes | Measure change in maternal blood pressure and heart rate over 20 minutes following loading. |
Countries
United States
Outcome results
None listed