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NCT Number: NCT06146842

ED90 of Bupivacaine After Lidocaine Test Dose With DPE and EPL

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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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Ayumi Maeda, MD PhD

CONTACT

[email protected]

617-732-8216

About this study

The investigators will be conducting a randomized controlled trial with patients randomized into either an EPL or a DPE group. For the first subject in the DPE and EPL techniques, the initial dose of bupivacaine 25 mg will be used, 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. Hence, if the first subject does not respond successfully, the dose for the second subject will be bupivacaine 27.5 mg. If the second subject does not respond successfully, the dose for the third subject will be bupivacaine 30 mg. By contrast, if a subject responds successfully, the bupivacaine dose will be decreased to 22.5 mg with a probability of 10% and maintained with a probability of 90% (ratio 1:9).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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

  • 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)

Treatment and study plan

Bupivacaine Hydrochloride

Drug

Each subject will receive allocated dose of bupivacaine

Primary outcomes

  1. NRS <3 at 30 min

    Time frame: 30 minutes after time 0.

    Adequate analgesia is defined as NRS score less than 3 at 30 minutes after time 0.

Study contacts

Contact information is provided by the study sponsor or research team.

Ayumi Maeda, MD

CONTACT

[email protected]

Lawrence Tsen, MD

CONTACT

[email protected]

617-732-8216

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

A Trial to Determine the Optimal Bupivacaine Dose for Initiation of Labor Epidural Pain Relief With a Lidocaine Test Dose

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Nov 27, 2023
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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