ED90 of Bupivacaine After Lidocaine Test Dose with DPE and EPL

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Nov 18, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the best dose of a medication called bupivacaine, which is used for pain relief during labor. The researchers want to find out how much bupivacaine is needed after a test dose of another medication, lidocaine, to ensure that 90% of women in labor feel comfortable. They will use two different methods of giving the medication and compare them to see which one works better. This study is important because it could help determine the best pain relief options for women during labor.

To participate in this trial, women must be healthy without major medical conditions, be at full term in their pregnancy (between 37 and 42 weeks), and be experiencing moderate to severe pain as they request an epidural for labor. Participants will receive an epidural for pain relief and may have a chance to contribute to important findings about labor pain management. It's important to note that women with certain health issues or complications in their pregnancy may not be eligible for this study.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Parturient with no major co-morbidities
• • 2. Singleton, vertex gestation at term (37-42 weeks)
• • 3. Less than or equal to 5 cm dilation
• • 4. Desire to receive epidural labor analgesia
• • 5. Numerical Rating Scale greater than or equal to 5 (NRS 0-10, where 0 = no pain, and 10 = worst pain imaginable), at time of epidural labor analgesia request.
• Exclusion Criteria:
• • 1. Current or historical evidence of clinically significant disease or condition, including diseases of pregnancy (i.e., preeclampsia, gestational diabetes)
• • 2. Any contraindication to the administration of an epidural technique (e.g., thrombocytopenia, antiplatelet meds).
• • 3. History of hypersensitivity or idiosyncratic reaction to an amide local anesthetic agent
• • 4. Evidence of anticipated fetal complications (i.e., fetal anomalies, IUGR (Intrauterine Growth Restriction), oligohydramnios, polyhydramnios)