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Completed

NCT Number: NCT04814537

Optimal Bupivacaine Dose for Initiation of Labor Epidural Techniques

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

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 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

Treatment and study plan

Bupivacaine Hydrochloride

Drug

Local Anesthetic Agent

Other names: Marcaine

Primary outcomes

  1. Verbal Numerical Rating Score (0-10, with higher scores meaning more pain); goal with analgesia is < 3/10

    Time frame: 30 minutes

    Pain Score (0=no pain, 10= worst pain imaginable)

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 24, 2021
Registry last updated
Aug 4, 2022

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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