NCT03587441 - 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)

Arevalo-Rodriguez I, Muñoz L, Godoy-Casasbuenas N, Ciapponi A, Arevalo JJ, Boogaard S, Roqué I Figuls M
Needle gauge and tip designs for preventing post-dural puncture headache (PDPH). Cochrane Database Syst Rev. 2017 Apr 7;4:CD010807. doi: 10.1002/14651858.CD010807.pub2. Review.
Cossu AP, De Giudici LM, Piras D, Mura P, Scanu M, Cossu M, Saba M, Finco G, Brazzi L
A systematic review of the effects of adding neostigmine to local anesthetics for neuraxial administration in obstetric anesthesia and analgesia. Int J Obstet Anesth. 2015 Aug;24(3):237-46. doi: 10.1016/j.ijoa.2015.05.002. Epub 2015 May 19. Review.
Fattahi Z, Hadavi SM, Sahmeddini MA
Effect of ondansetron on post-dural puncture headache (PDPH) in parturients undergoing cesarean section: a double-blind randomized placebo-controlled study. J Anesth. 2015 Oct;29(5):702-7. doi: 10.1007/s00540-015-2000-5. Epub 2015 Mar 27.
Headache Classification Committee of the International Headache Society (IHS)
The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658.
Nath S, Koziarz A, Badhiwala JH, Alhazzani W, Jaeschke R, Sharma S, Banfield L, Shoamanesh A, Singh S, Nassiri F, Oczkowski W, Belley-Côté E, Truant R, Reddy K, Meade MO, Farrokhyar F, Bala MM, Alshamsi F, Krag M, Etxeandia-Ikobaltzeta I, Kunz R, Nishida O, Matouk C, Selim M, Rhodes A, Hawryluk G, Almenawer SA
Atraumatic versus conventional lumbar puncture needles: a systematic review and meta-analysis. Lancet. 2018 Mar 24;391(10126):1197-1204. doi: 10.1016/S0140-6736(17)32451-0. Epub 2017 Dec 7. Review.

The Efficacy of Neostigmine as an Adjuvant to Bupivacaine for Intrathecal Block in Reducing the Incidence and Severity of Post-Dural Puncture Headache for Parturients Scheduled for Elective Caesarean Section

Details for clinical trial NCT03587441

Clinical trial NCT03587441 - References