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Purpose

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"

Conditions

Eligibility

Eligible Ages
Between 18 Years and 50 Years
Eligible Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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 - Numerical Rating Scale greater 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

  • 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. - Evidence of anticipated fetal anomalies

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Randomized Controlled Trial Using Biased Coin Design to Determine Effective Dose for 90% (ED90) of Subjects
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
The biased-coin allocation after each successful response will be implemented by flipping a virtual biased coin (10% vs. 90% probability of randomizing the next patient to the lower vs. same dose than received by the last patient with the same epidural technique) using R statistical software (R Foundation for Statistical Computing, Vienna, Austria). Care Provider (Clinical Anesthesiologist) will administer the identified dose, then summon blinded observer.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dural Puncture Epidural Technique 		Laboring women receiving the Dural Puncture Epidural (DPE) Technique, after a lidocaine "test dose", with dose of Bupivacaine 0.25% diluted to 20 mL with isotonic sterile 0.9% saline. The first subject in the DPE group will receive an initial dose of bupivacaine 25 mg, with an endpoint being the achievement of an NRS < 3 at 30 min. Subsequent patients are administered bupivacaine doses determined by the response of the previous subject, as per the biased coin method. The subsequent up and down interval doses are bupivacaine 2.5 mg (1 mL) increments, with an anticipated dose range from 20 mg to 40 mg.
  • Drug: Bupivacaine Hydrochloride
    Subjects will receive a dose of bupivacaine as described in the arm section of this trial
Active Comparator
Epidural Technique 		Laboring women receiving the Conventional Epidural Technique (EPL), after receiving a lidocaine "test dose" with dose of Bupivacaine 0.25% diluted to 20 mL with isotonic sterile 0.9% saline. The first subject in the EPL group will receive an initial dose of bupivacaine 25 mg, with an endpoint being the achievement of an NRS < 3 at 30 min. Subsequent patients are administered bupivacaine doses determined by the response of the previous subject, as per the biased coin method. The subsequent up and down interval doses are bupivacaine 2.5 mg (1 mL) increments, with an anticipated dose range from 20 mg to 40 mg.
  • Drug: Bupivacaine Hydrochloride
    Subjects will receive a dose of bupivacaine as described in the arm section of this trial

Recruiting Locations

Brigham and Women's Hospital
Boston, Massachusetts 02115
Contact:
Lawrence C Tsen, MD
617-732-8216
ltsen@zeus.bwh.harvard.edu

More Details

Status
Recruiting
Sponsor
Brigham and Women's Hospital

Study Contact

Lawrence C Tsen, MD
617-732-8216
ltsen@bwh.harvard.edu

Detailed Description

The primary objective of our study is to use a biased coin up-down allocation methodology 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 induction or augmentation; we hypothesize that we will be able to determine the ED90 of bupivacaine for each technique with adequate precision to inform the optimal doses. We will be conducting this study in women who receive a prior lidocaine "test dose" used in standard clinical practice

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.