drugset / Trial / NCT02801799

Effects of Local Anaesthetic Infusion Rates on Nerve Block Duration

NCT02801799 ↗

Phase 1 Terminated 60 enrolled Nordsjaellands Hospital
RandomizedParallel-groupTriple-blindBasic science

Summary

This trial is a part of the project: 'A novel technique for reliable, precise and safe postoperative pain management' (project no. 65-2014-3). The purpose of the trial is to investigate the effects of changing peri-neural infusion rates of ropivacaine 0.2% on the duration of nerve block. Intervention: Two intervention-days. Each day a peri-neural infusion of a fixed volume of ropivacaine 0.2% is to be infused in one of five infusion rates, using a peri-neural catheter. Intervention day 1: Focus on the common peroneal nerve. Intervention day 2: Focus on the sciatic nerve.

Timeline

Start
2016-10-10
Primary completion
2016-11-23
Completion
2016-12-09

Outcome

Missed primary endpoint

Stopped: “The trial was comprised of two parts. After the first part we could repudiate our hypothesis. Thus, no reason to carry on with the second part of the trial.”

paper We found no differences in sensory block duration between the 5 groups. PMID 29570501 ↗

paper Durations were median [range]: 11 [6-14], 12 [9-14], 10.5 [2-15], 11 [8-17], and 12 [9-18] hours, respectively (P = 0.294). PMID 29570501 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ropivacaine Other / unclassified 0.2 % Other

Indications