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ED90 of Bupivacaine After Lidocaine Test Dose With DPE and EPL

RecruitingPhase 4Ages any - anyFemaleBrigham and Women's Hospital
NCT06146842 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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)
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What it tests

  • Bupivacaine Hydrochloride
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Where

1 site
Brigham and Women's Hospital
Boston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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