Displacement of Popliteal Sciatic Nerve Catheters After Major Foot and Ankle Surgery

June 10, 2015 updated by: Rasmus Wulff Hauritz, Kolding Sygehus
Displacement of popliteal sciatic nerve catheters after major foot and ankle surgery. A randomized controlled double blinded MRI study comparing long versus short axis catheter placement. Which procedure for insertion of nerve catheters for postoperative pain after major foot and ankle surgery is the best

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region Midt
      • Aarhus, Region Midt, Denmark, 8000
        • Department of Anesthesia, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 y.
  • Major foot and ankle surgery postoperativ pain treatment with sciatic nerve catheter r
  • Written and informed concent

Exclusion Criteria:

  • Patient uanble to cooperate
  • Patients not speaking and understanding Danish or English
  • Patiens in immunosuppresive treatment
  • Patienter with neuropathys in lower extremities
  • Allergies to the in the protocole listes medicines
  • A daily opoid intake
  • Pregnant women
  • Patients not meeting MR-criterias (metal, claustofobia...)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SAX
Ultrasound guided short axis (SAX) placement of sciatic nerve catheters
Procedure: Ultrasound guided short axis (SAX) placement of sciatic nerve catheters
Sonosite EDGE ultrasound scanner guided insertion of a B Braun Contiplex S catheter along the short axis of the sciatic nerve behind the knee.
Device: B Braun Contiplex S catheter
Active Comparator: LAX
Ultrasound guided long axis (LAX) placement of sciatic nerve catheters
Device: B Braun Contiplex S catheter
Procedure: Ultrasound guided long axis (LAX) placement of sciatic nerve catheters
Sonosite EDGE ultrasound scanner guided insertion of a B Braun Contiplex S catheter along the long axis of the sciatic nerve behind the knee.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of nerve catheter displacement
Time Frame: 48 hours after catheter placement
48 hours after catheter placement

Secondary Outcome Measures

Outcome Measure
Time Frame
Opioid comsumption
Time Frame: Within first 48 hours postoperatively
Within first 48 hours postoperatively
Number of rescue blocks
Time Frame: Within 48 hours postoperatively
Within 48 hours postoperatively
Postoperativ pain after local anesthetic injection via sciatic nerve catheter
Time Frame: Within 48 hours postoperatively
Within 48 hours postoperatively
MR evaluated distribution of local anesthetic after injection MR-contrast
Time Frame: 48 hours after catheter placement
48 hours after catheter placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kolding Sygehus

Collaborators

Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

July 23, 2014

First Submitted That Met QC Criteria

July 23, 2014

First Posted (Estimate)

July 25, 2014

Study Record Updates

Last Update Posted (Estimate)

June 11, 2015

Last Update Submitted That Met QC Criteria

June 10, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-000707-28

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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