drugset / Trial / NCT02172729

The Effect of Different Doses (Mass) of Local Anesthetic on Duration of Adductor Canal Block in Healthy Volunteers - Part 2

NCT02172729 ↗

Phase 4 Completed 14 enrolled Rigshospitalet, Denmark
RandomizedCrossoverQuadruple-blindTreatment

Summary

To investigate whether increased dose of local anesthetic (lidocaine) increases duration of peripheral nerve block (adductor canal block) and to develop a model for assessing duration of peripheral nerve blockades. The investigators hypothesize that increasing the dose of lidocaine (by increased concentration) will increase the duration of an adductor canal block. The study is a follow up on an identical study (SM1-PJ-13, EudraCT number: 2013-001822-24 ) made earlier with different concentrations of lidocaine and a placebo group. For further information see trial registration at European Union Drug Regulatory Authorities Clinical Trial System.

Timeline

Start
2014-06
Primary completion
2014-07
Completion
2014-07

Outcome

Missed primary endpoint

paper In study 2, all but 1 test showed no difference in duration despite a 3-fold increase in dose. PMID 27537926 ↗

paper We did not find evidence that increasing the total dose of lidocaine may prolong duration of an ACB. PMID 27537926 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Lidocaine Other / unclassified 100 mg —
Subject Lidocaine Other / unclassified 300 mg —

Indications

No indication recorded.