NCT05960799 - 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)

Ilfeld BM
Continuous Peripheral Nerve Blocks: An Update of the Published Evidence and Comparison With Novel, Alternative Analgesic Modalities. Anesth Analg. 2017 Jan;124(1):308-335. doi: 10.1213/ANE.0000000000001581.
Ip VH, Rockley MC, Tsui BC
The catheter-over-needle assembly offers greater stability and less leakage compared with the traditional counterpart in continuous interscalene nerve blocks: a randomized patient-blinded study. Can J Anaesth. 2013 Dec;60(12):1272-3. doi: 10.1007/s12630-013-0032-6. Epub 2013 Sep 17. No abstract available.
Malik T, Mass D, Cohn S
Postoperative Analgesia in a Prolonged Continuous Interscalene Block Versus Single-Shot Block in Outpatient Arthroscopic Rotator Cuff Repair: A Prospective Randomized Study. Arthroscopy. 2016 Aug;32(8):1544-1550.e1. doi: 10.1016/j.arthro.2016.01.044. Epub 2016 Apr 20.
Nogawa R, Maruyama T, Kimoto Y, Yamazaki A, Kawamata T
Comparison of catheter-over-needle and catheter-through-needle on leakage from the catheter insertion site during continuous femoral nerve block. J Anesth. 2018 Jun;32(3):439-442. doi: 10.1007/s00540-018-2479-7. Epub 2018 Mar 22.
Tsui BC, Ip VH
Catheter-over-needle method reduces risk of perineural catheter dislocation. Br J Anaesth. 2014 Apr;112(4):759-60. doi: 10.1093/bja/aeu066. No abstract available.
Tsui BC, Tsui J
Less leakage and dislodgement with a catheter-over-needle versus a catheter-through-needle approach for peripheral nerve block: an ex vivo study. Can J Anaesth. 2012 Jul;59(7):655-61. doi: 10.1007/s12630-012-9713-9. Epub 2012 May 8.

Randomizes Control Trial (RCT): Superiority Study on Inter Scalene Block Execution Time for Shoulder Traumatology Surgery and Non-inferiority for Effectiveness Between Two Block Methods: Catheter Over Needle (CON) vs Catheter Through Needle (CTN).

Details for clinical trial NCT05960799

Clinical trial NCT05960799 - References