NCT04814537: Optimal Bupivacaine Dose for Initiation of Labor Epidural Techniques

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.

Timeline

Start: 2021-02-25
Primary completion: 2022-03-23
Completion: 2022-03-23

Publications

Results 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.
Results 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.
Results 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.
Maeda A, Villela-Franyutti D, Lumbreras-Marquez MI, Murthy A, Fields KG, Justice S, Tsen LC. Labor Analgesia Initiation With Dural Puncture Epidural Versus Conventional Epidural Techniques: A Randomized Biased-Coin Sequential Allocation Trial to Determine the Effective Dose for 90% of Patients of Bupivacaine. Anesth Analg. 2024 Jun 1;138(6):1205-1214. doi: 10.1213/ANE.0000000000006691. Epub 2023 Oct 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bupivacaine	Other / unclassified	20 mg	Other
Subject	Bupivacaine	Other / unclassified	22.5 mg	Other
Subject	Bupivacaine	Other / unclassified	25 mg	Other
Subject	Bupivacaine	Other / unclassified	27.5 mg	Other
Subject	Bupivacaine	Other / unclassified	30 mg	Other
Subject	Bupivacaine	Other / unclassified	32.5 mg	Other
Subject	Bupivacaine	Other / unclassified	35 mg	Other
Subject	Bupivacaine	Other / unclassified	37.5 mg	Other
Subject	Bupivacaine	Other / unclassified	40 mg	Other

Indications

No indication recorded.