ED90 of Bupivacaine After Lidocaine Test Dose with DPE and EPL

NCT06146842 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2023p003001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Labor Pain

Outcome Measures

Primary Outcomes (1)

• NRS <3 at 30 min

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

  30 minutes after time 0.

Study Arms (2)

DPE Group

ACTIVE COMPARATOR

Subjects will receive an epidural catheter via a dural puncture epidural technique.

Drug: Bupivacaine Hydrochloride

EPL Group

ACTIVE COMPARATOR

Subjects will receive an epidural catheter via a traditional epidural technique.

Drug: Bupivacaine Hydrochloride

Interventions

Bupivacaine Hydrochloride DRUG

Each subject will receive allocated dose of bupivacaine

DPE Group; EPL Group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Labor Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Lawrence Tsen, MD

CONTACT

617-732-8216; ltsen@bwh.harvard.edu

Ayumi Maeda, MD

CONTACT

amaeda@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Anaesthesia

Model Details: A Randomized Biased-Coin Sequential Allocation Trial

Study Record Dates

• First Submitted: November 18, 2023
• First Posted: November 27, 2023
• Study Start: December 1, 2023
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: February 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)