A randomised, non-inferiority study of chloroprocaine 2% and ropivacaine 0.75% in ultrasound-guided axillary block

Irene Sulyok, Claudio Camponovo, Oliver Zotti, Werner Haslik, Markus Köstenberger, Rudolf Likar, Chiara Leuratti, Elisabetta Donati, Oliver Kimberger, Irene Sulyok, Claudio Camponovo, Oliver Zotti, Werner Haslik, Markus Köstenberger, Rudolf Likar, Chiara Leuratti, Elisabetta Donati, Oliver Kimberger

Abstract

Chloroprocaine is a short-acting local anaesthetic with a rapid onset of action and an anaesthesia duration up to 60 min. In this pivotal study success rates, onset and remission of motor and sensory block and safety of chloroprocaine 2% was compared to ropivacaine 0.75% for short-duration distal upper limb surgery with successful block rates as primary outcome. The study was designed as a prospective, randomised, multi-centre, active-controlled, double-blind, parallel-group, non-inferiority study, performed in 4 European hospitals with 211 patients scheduled for short duration distal upper limb surgery under axillary plexus block anaesthesia. Patients received either ultrasound guided axillary block with 20 ml chloroprocaine 2%, or with 20 ml ropivacaine 0.75%. Successful block was defined as block without any supplementation in the first 45 min calculated from the time of readiness for surgery. 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). Time to onset of block was not significantly different between the groups. Median time to motor and sensory block regression was significantly shorter as was time to home discharge (164 [155-170] min for chloroprocaine versus 380 [209-450] for the ropivacaine group, p < 0.001). For short-duration surgical procedures, the short-acting Chloroprocaine 2% may be used, with success rates non-inferior to ropivacaine and a favourable safety profile.Trial registration: The trial was registered at Clinicaltrials.gov with registration number NCT02385097 (March 11th, 2015) and European Clinical Trial Database with the EudraCT number 2014-002519-40 (July 7th, 2015, Austria-BASG).

Conflict of interest statement

ED is an employee of Sintetica S.A., Switzerland; CL is an employee of CROSS Research S.A., Switzerland. CROSS Research S.A. was contracted by Sintetica S.A. as CRO for study coordination, analysis and reporting and received financial support for its services. OK received honoraria for lecturing from Sintentica. S.A. The authors declare that they have no other relationships or activities that could appear to have influenced the submitted work. All authors not abovementioned with competing interests declare that they do not have any additional conflict of interest. This study was funded by Sintetica S.A., Switzerland.

Figures

Figure 1
Figure 1
CONSORT flow diagram.
Figure 2
Figure 2
Time to regression of motor block (min).
Figure 3
Figure 3
Time to regression of sensory block (min).
Figure 4
Figure 4
Time to eligibility of home discharge (min).

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