Optimizing Dose of Bupivacaine in Combined Spinal Epidurals To Reduce Side Effects

Completed · Not applicable

Conditions studied: Pregnancy

In brief

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.

Key facts

Study ID

NCT02159807

Run by

St. Luke's-Roosevelt Hospital Center

People needed

170

Starts

2015-04-24

Expected to finish

2017-12-29

Last updated by the study team

2019-01-03

Who can join

Age: 18 and older, up to 48. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Roosevelt hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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