NCT04254081 - 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)

Bailard NS, Ortiz J, Flores RA
Additives to local anesthetics for peripheral nerve blocks: Evidence, limitations, and recommendations. Am J Health Syst Pharm. 2014 Mar 1;71(5):373-85. doi: 10.2146/ajhp130336.
Creinin MD, Schimmoeller NR, Matulich MC, Hou MY, Melo J, Chen MJ
Gabapentin for pain management after osmotic dilator insertion and prior to dilation and evacuation: A randomized controlled trial. Contraception. 2020 Mar;101(3):167-173. doi: 10.1016/j.contraception.2019.12.001. Epub 2020 Jan 10.
Kosel J, Bobik P, Tomczyk M
Buprenorphine--the unique opioid adjuvant in regional anesthesia. Expert Rev Clin Pharmacol. 2016;9(3):375-83. doi: 10.1586/17512433.2016.1141047. Epub 2016 Jan 28.
Mercier RJ, Liberty A
Intrauterine lidocaine for pain control during laminaria insertion: a randomized controlled trial. Contraception. 2014 Dec;90(6):594-600. doi: 10.1016/j.contraception.2014.07.008. Epub 2014 Jul 23.
Schivone GB, Lerma K, Montgomery C, Wright P, Conti JA, Blumenthal PD, Shaw KA
Self-administered lidocaine gel for local anesthesia prior to osmotic dilator placement: a randomized trial. Contraception. 2019 Mar;99(3):148-151. doi: 10.1016/j.contraception.2018.11.013. Epub 2018 Nov 27.
Soon R, Tschann M, Salcedo J, Stevens K, Ahn HJ, Kaneshiro B
Paracervical Block for Laminaria Insertion Before Second-Trimester Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2017 Aug;130(2):387-392. doi: 10.1097/AOG.0000000000002149.
Swain A, Nag DS, Sahu S, Samaddar DP
Adjuvants to local anesthetics: Current understanding and future trends. World J Clin Cases. 2017 Aug 16;5(8):307-323. doi: 10.12998/wjcc.v5.i8.307.

Addition of Buprenorphine to Paracervical Block Prior to Osmotic Dilator Insertion for Dilation and Evacuation: A Randomized Controlled Trial

Details for clinical trial NCT04254081

Clinical trial NCT04254081 - References