RECRUITING

ED90 of Epidural Bupivacaine With Lidocaine for the Initiation of Labor Analgesia

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Conditions

Labor PainAnalgesiaDural puncture epiduralNeuraxial AnalgesiaBupivacaineLocal Anesthetic

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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"

Official Title

ED90 of Epidural Bupivacaine for the Initiation of Labor Analgesia: A Randomized Biased Coin Sequential Allocation Trial With a Lidocaine Test Dose

Quick Facts

Study Start:2022-10-01
Study Completion:2024-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05543694

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion 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 or equal to 5 (NRS 0-10, where 0 = no pain, and 10 = worst pain imaginable), at time of epidural labor analgesia request.
  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
  3. * History of hypersensitivity or idiosyncratic reaction to an amide local anesthetic agent
  4. * 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.
  5. * Evidence of anticipated fetal anomalies

Contacts and Locations

Study Contact

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

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-01
Study Completion Date2024-10-01

Study Record Updates

Study Start Date2022-10-01
Study Completion Date2024-10-01

Terms related to this study

Keywords Provided by Researchers

  • Dural puncture epidural
  • Neuraxial Analgesia
  • Bupivacaine
  • Local Anesthetic

Additional Relevant MeSH Terms

  • Labor Pain
  • Analgesia