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Completed

NCT Number: NCT02200016

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

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

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Regional Anesthesia Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anesthesia, Aarhus University Hospital

Aarhus, Region Midt, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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...)

Treatment and study plan

Ultrasound guided short axis (SAX) placement of sciatic nerve catheters

Procedure

Sonosite EDGE ultrasound scanner guided insertion of a B Braun Contiplex S catheter along the short axis of the sciatic nerve behind the knee.

Ultrasound guided long axis (LAX) placement of sciatic nerve catheters

Procedure

Sonosite EDGE ultrasound scanner guided insertion of a B Braun Contiplex S catheter along the long axis of the sciatic nerve behind the knee.

B Braun Contiplex S catheter

Device

Primary outcomes

  1. Frequency of nerve catheter displacement

    Time frame: 48 hours after catheter placement

Secondary outcomes

  1. Opioid comsumption

    Time frame: Within first 48 hours postoperatively

  2. Number of rescue blocks

    Time frame: Within 48 hours postoperatively

  3. Postoperativ pain after local anesthetic injection via sciatic nerve catheter

    Time frame: Within 48 hours postoperatively

  4. MR evaluated distribution of local anesthetic after injection MR-contrast

    Time frame: 48 hours after catheter placement

Sponsors and collaborators

Lead sponsor

Kolding Sygehus

Other

Collaborators

  • Aarhus University Hospital

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 25, 2014
Registry last updated
Jun 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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