ED90 of Bupivacaine After Lidocaine Test Dose With DPE and EPL

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06146842
• Other study ID #: 2023p003001
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Brigham and Women's Hospital
• Contact: Lawrence Tsen, MD
• Phone: 617-732-8216
• Email: ltsen[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Labor Pain

Intervention

Drug:
• Bupivacaine Hydrochloride
Each subject will receive allocated dose of bupivacaine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.