ED90 of Epidural Bupivacaine With Lidocaine for the Initiation of Labor Analgesia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorBrigham and Women's Hospital
About this trial
To estimate the dose of bupivacaine required to achieve initial effective comfort in 90% of patients (ED90) via the epidural (DPE or EPL) technique in women undergoing labor after receiving a lidocaine "test dose"
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
History of hypersensitivity or idiosyncratic reaction to an amide local anesthetic agent
Current or historical evidence of a disease which may result in the risk of a cesarean delivery (i.e. history of uterine rupture). NB: Exception-trial of labor after cesarean delivery (TOLAC) will be eligible.
Trial design
Design model
Parallel
Treatments tested in this trial
Bupivacaine Hydrochloride
DrugSubjects will receive a dose of bupivacaine as described in the arm section of this trial
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Dural Puncture Epidural TechniqueExperimental treatment 1 intervention
Group B: Epidural TechniqueActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Verbal Numerical Pain Rating Score
(0-10, with higher scores meaning more pain); goal with analgesia is \< 3/10
Time frame
30 minutesSponsors and contacts
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Source ClinicalTrials.gov