ED90 of Bupivacaine After Lidocaine Test Dose with DPE and EPL

NCT ID: NCT06146842

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2026-01-31

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.

Detailed Description

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).

Conditions

Labor Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

DPE Group

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

Group Type: ACTIVE_COMPARATOR

Bupivacaine Hydrochloride

Intervention Type: DRUG

Each subject will receive allocated dose of bupivacaine

EPL Group

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

Group Type: ACTIVE_COMPARATOR

Bupivacaine Hydrochloride

Intervention Type: DRUG

Each subject will receive allocated dose of bupivacaine

Interventions

Bupivacaine Hydrochloride

Each subject will receive allocated dose of bupivacaine

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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 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

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 (e.g., thrombocytopenia, antiplatelet meds).

3. History of hypersensitivity or idiosyncratic reaction to an amide local anesthetic agent

4. Evidence of anticipated fetal complications (i.e., fetal anomalies, IUGR (Intrauterine Growth Restriction), oligohydramnios, polyhydramnios)

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lawrence Ching Tsen

Associate Professor in Anaesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lawrence Tsen, MD

Role: CONTACT

ltsen@bwh.harvard.edu

617-732-8216

Ayumi Maeda, MD

Role: CONTACT

amaeda@bwh.harvard.edu

Facility Contacts

Ayumi Maeda, MD PhD

Role: primary

amaeda@bwh.harvard.edu

1-617-732-8216

Other Identifiers

2023p003001

Identifier Type: -

Identifier Source: org_study_id