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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05543694
• Other study ID #: 2022P002226
• Status: Recruiting
• Phase: Phase 4
• Start date: October 1, 2022
• Est. completion date: October 1, 2024

Study information

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

Clinical Trial Summary

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"

Description:

The primary objective of our study is to use a biased coin up-down allocation methodology 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 induction or augmentation; we hypothesize that we will be able to determine the ED90 of bupivacaine for each technique with adequate precision to inform the optimal doses. We will be conducting this study in women who receive a prior lidocaine "test dose" used in standard clinical practice

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 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

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

• 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.

• Evidence of anticipated fetal anomalies

Related Conditions & MeSH terms

• Analgesia
• Labor Pain

Intervention

Drug:
• Bupivacaine Hydrochloride
Subjects will receive a dose of bupivacaine as described in the arm section of this trial

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (3)

Benhamou D, Ghosh C, Mercier FJ. A randomized sequential allocation study to determine the minimum effective analgesic concentration of levobupivacaine and ropivacaine in patients receiving epidural analgesia for labor. Anesthesiology. 2003 Dec;99(6):1383-6. doi: 10.1097/00000542-200312000-00022. — View Citation

Chau A, Bibbo C, Huang CC, Elterman KG, Cappiello EC, Robinson JN, Tsen LC. Dural Puncture Epidural Technique Improves Labor Analgesia Quality With Fewer Side Effects Compared With Epidural and Combined Spinal Epidural Techniques: A Randomized Clinical Trial. Anesth Analg. 2017 Feb;124(2):560-569. doi: 10.1213/ANE.0000000000001798. — View Citation

Ngan Kee WD, Ng FF, Khaw KS, Lee A, Gin T. Determination and comparison of graded dose-response curves for epidural bupivacaine and ropivacaine for analgesia in laboring nulliparous women. Anesthesiology. 2010 Aug;113(2):445-53. doi: 10.1097/ALN.0b013e3181bdf9da. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Verbal Numerical Pain Rating Score	(0-10, with higher scores meaning more pain); goal with analgesia is < 3/10	30 minutes