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Protracted Effect of the Ultrasound-guided Saphenous Block

NCT02346110 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-02-12

No results posted yet for this study

Summary

This study focuses on optimizing the postoperative pain treatment after major foot and ankle surgery by prolonging the duration of the ultrasound-guided saphenous block. The currently used single shot saphenous block only covers half of the pain intensive period from the saphenous territory, which results in a sharp, break-through pain requiring opioids. The hypothesis is that this protracted mixture will keep the patients free of pain without the use of opioids for the entire pain intensive period and thus increase rehabilitation and patients' satisfaction.

Conditions

  • Arthrosis, Unspecified, Ankle and Foot

Interventions

DRUG

Bupivacaine-adrenaline

50 mg bupivacaine and 50 μg adrenalin

DRUG

Dexamethasone

4 mg

OTHER

Sodium chloride

1 mL of sodium chloride solution as placebo

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Thomas Fichtner Bendtsen, MD, phD · Department of Anesthesiology, Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-12-31
Completion
2016-02-29

Countries

  • Denmark

Study Locations

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Entities

Drugs

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 NCT02346110 on ClinicalTrials.gov