ED90 of Bupivacaine After Lidocaine Test Dose With DPE and EPL

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06146842

Collaborator

(none)

120

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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; we hypothesize that we 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. We also hypothesize that the post test-dose ED90 of bupivacaine is lower with a DPE technique than with a conventional epidural technique.

Condition or Disease	Intervention/Treatment	Phase
Labor Pain	Drug: Bupivacaine Hydrochloride	N/A

Detailed Description

We 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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

A Randomized Biased-Coin Sequential Allocation TrialA Randomized Biased-Coin Sequential Allocation Trial

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: DPE Group Subjects will receive an epidural catheter via a dural puncture epidural technique.	Drug: Bupivacaine Hydrochloride Each subject will receive allocated dose of bupivacaine
Active Comparator: EPL Group Subjects will receive an epidural catheter via a traditional epidural technique.	Drug: Bupivacaine Hydrochloride Each subject will receive allocated dose of bupivacaine

Arm

Intervention/Treatment

Active Comparator: DPE Group

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

Drug: Bupivacaine Hydrochloride

Each subject will receive allocated dose of bupivacaine

Active Comparator: EPL Group

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

Drug: Bupivacaine Hydrochloride

Each subject will receive allocated dose of bupivacaine

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Brigham and Women's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lawrence Ching Tsen, Associate Professor in Anaesthesia, Brigham and Women's Hospital

ClinicalTrials.gov Identifier:

NCT06146842

Other Study ID Numbers:

2023p003001

First Posted:

Nov 27, 2023

Last Update Posted:

Nov 27, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Labor Pain

Bupivacaine

Study Results

No Results Posted as of Nov 27, 2023