NCT05217134 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Cappiello E, O'Rourke N, Segal S, Tsen LC
A randomized trial of dural puncture epidural technique compared with the standard epidural technique for labor analgesia. Anesth Analg. 2008 Nov;107(5):1646-51. doi: 10.1213/ane.0b013e318184ec14.
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 Tr
Contreras F, Morales J, Bravo D, Layera S, Jara Á, Riaño C, Pizarro R, De La Fuente N, Aliste J, Finlayson RJ, Tran DQ
Dural puncture epidural analgesia for labor: a randomized comparison between 25-gauge and 27-gauge pencil point spinal needles. Reg Ane
Gunaydin B, Erel S
How neuraxial labor analgesia differs by approach: dural puncture epidural as a novel option. J Anesth. 2019 Feb;33(1):125-130. doi: 10.1007/s00540-018-2564-y. Epub 2018 Oct 6. Review.
Shmueli A, Salman L, Orbach-Zinger S, Aviram A, Hiersch L, Chen R, Gabbay-Benziv R
The impact of epidural analgesia on the duration of the second stage of labor. Birth. 2018 Dec;45(4):377-384. doi: 10.1111/birt.12355. Epub 2018 May 22.
Song Y, Du W, Zhou S, Zhou Y, Yu Y, Xu Z, Liu Z
Effect of Dural Puncture Epidural Technique Combined With Programmed Intermittent Epidural Bolus on Labor Analgesia Onset and Maintenance: A Randomized Controlled Trial. Anesth Analg. 2021 Apr 1;132(4):971-
Thomas JA, Pan PH, Harris LC, Owen MD, D'Angelo R
Dural puncture with a 27-gauge Whitacre needle as part of a combined spinal-epidural technique does not improve labor epidural catheter function. Anesthesiology. 2005 Nov;103(5):1046-51.

Sacral Anesthetic Block During Labor Analgesia With a With a 27-G Whitacre Spinal Needle - Dural Puncture Epidural Technique vs Standard Epidural Technique: a Randomized Controlled Study.

Details for clinical trial NCT05217134

Clinical trial NCT05217134 - References