N/A
N=170
Optimizing Dose of Bupivacaine in Combined Spinal Epidurals To Reduce Side Effects
Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT02159807 ↗Enrolled (actual)
170
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Maternal Blood Pressure — 78.2; 79.58; 80.52 mm/Hg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bupivacaine (Drug); Fentanyl (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- St. Luke's-Roosevelt Hospital Center
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maternal Blood Pressure |
78.2; 79.58; 80.52 | — |
| SECONDARY Fetal Heart Rate at 1 Hour |
134.73; 137.64; 135.57 | — |
| SECONDARY Mean Change in Visual Analog Scale for Pain |
0.43; 0.46; 0.26 | — |
Summary
The purpose of this study is to determine what dose of medication administered through a combined spinal epidural (CSE) provides the optimal pain relief with the minimal amount of side effects. The 3 doses studied here (1.25, 1.66 and 2.5mg) are routinely use on the labor floor (depending on the physician preference) but the idea is to quantify safety, efficacy and side effects for each of these doses.
Eligibility Criteria
Inclusion Criteria
- ASA (American Society of Anesthesiologists Physical status) 1-2 parturients at term requesting labor analgesia
- between 37 and 42 weeks gestational age
- maternal age of 18 years or greater
Exclusion Criteria
- Parturients with pre-eclampsia
- History of pregnancy induced hypertension
- Patients in whom a spinal anesthetic is contraindicated (e.g. coagulopathy, local infection) or those in whom a CSE cannot be performed
- Patients with non reassuring fetal heart rate tracings prior to placement of the CSE
Data sourced from ClinicalTrials.gov (NCT02159807). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.