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Effects of Local Anaesthetic Infusion Rates on Nerve Block Duration

NCT02801799 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-03-30

No results posted yet for this study

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.

Conditions

  • Other Acute Postoperative Pain
  • Pain, Postoperative
  • Anaesthesia

Interventions

DRUG

Varying infusion rates of Ropivacaine 0.2%

Participants will receive one nerve catheter adjacent to the common peroneal nerve (trial day 1) and adjacent to the sciatic nerve (trial day 2). Each catheter will be randomly allocated to one of five infusion groups. All peroneal nerve catheters will receive the same volume of ropivacaine 0.2%. All the sciatic nerve catheters will receive the same volume of ropivacaine 0.2%. The only inter-group variable will be the infusion rate. The fixed volume of ropivacaine will be determined in a separate study ('The Volume Study'), which is also part of the project: 'A novel technique for reliable, precise and safe postoperative management'. The largest volumes tested in "The Volume Study" are 30 mL for the sciatic nerve and 20 mL for the common peroneal nerve. Therefore the highest volume for the two intervention days cannot exceed 30 mL (150 mg of ropivacaine). We will ensure constant infusion rate and precise delivery of LA by using an electronic infusion pump and a nerve catheter.

Sponsors & Collaborators

  • Nordsjaellands Hospital

    lead OTHER

Principal Investigators

  • Mikkel H. Madsen, MD · Research Unit, Department of Anaesthesiology and Intensive Care, Nordsjaellands Hospital Hilleroed

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Denmark

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02801799 on ClinicalTrials.gov