Chloroprocaine 2% vs Ropivacaine 0.75% in Ultrasound-guided Axillary Nerve Block

Phase 3 Completed 211 enrolled Sintetica SA Cross S.A. · collab

RandomizedParallel-groupTriple-blindOther

Summary

The Study evaluate the non-inferiority of Test product (Chloroprocaine 2%) versus Reference product (Ropivacaine 0.75%) in terms of proportion of subjects with a successful block for distal upper limb surgeries Successful block: anaesthesia adequate for the surgery without any supplementation in the first 45 min.

Timeline

Start: 2015-04
Primary completion: 2017-05
Completion: 2017-05

Outcome

Met primary endpoint

paper 90.8% patients achieved a successful block with chloroprocaine 2% and 92.9% patients with Ropivacaine 0.75%, thus non-inferiority was demonstrated (10% non inferiority margin; 95% CI - 0.097, 0.039; p = 0.02). PMID 33976374 ↗

Publications

Sulyok I, Camponovo C, Zotti O, Haslik W, Kostenberger M, Likar R, Leuratti C, Donati E, Kimberger O. A randomised, non-inferiority study of chloroprocaine 2% and ropivacaine 0.75% in ultrasound-guided axillary block. Sci Rep. 2021 May 11;11(1):10035. doi: 10.1038/s41598-021-89483-y.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Chloroprocaine	Other / unclassified	20 ml	Other
Comparator	Ropivacaine	Other / unclassified	20 ml	Other

Indications

No indication recorded.