ED90 of Bupivacaine After Lidocaine Test Dose With DPE and EPL
ConditionLabor Pain
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorBrigham and Women's Hospital
About this trial
The primary objective of our study is to use a biased coin up-down allocation methodology to estimate the dose of bupivacaine required after the lidocaine test dose to achieve initial effective comfort in 90% of patients (post test-dose ED90) via the epidural (DPE or EPL) technique in women undergoing labor induction or augmentation; the investigators hypothesize that the investigators will be able to determine the post test-dose ED90 of bupivacaine for each technique with adequate precision to inform the optimal doses to study in a subsequent randomized trial comparing the analgesic effects of DPE vs. EPL. The investigators also hypothesize that the post test-dose ED90 of bupivacaine is lower with a DPE technique than with a conventional epidural technique.
Eligibility criteria
Qualifiers
Parturient with no major co-morbidities
Singleton, vertex gestation at term (37-42 weeks)
Less than or equal to 5 cm dilation
Desire to receive epidural labor analgesia
Disqualifiers
Current or historical evidence of clinically significant disease or condition, including diseases of pregnancy (i.e., preeclampsia, gestational diabetes)
Any contraindication to the administration of an epidural technique (e.g., thrombocytopenia, antiplatelet meds).
History of hypersensitivity or idiosyncratic reaction to an amide local anesthetic agent
Evidence of anticipated fetal complications (i.e., fetal anomalies, IUGR (Intrauterine Growth Restriction), oligohydramnios, polyhydramnios)
Trial design
Treatments tested in this trial
- Bupivacaine Hydrochloride
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov