Which procedure for insertion of nerve catheters for postoperative pain after major foot and ankle surgery is the best

Conditions: The medical condition to be examined in this study, is postoperative pain after major foot and ankle surgery. Which way to insert a sciatic nerve catheter to treat postoperative pain is the most efficient and give the lowest rate of displacement
MedDRA version: 17.0Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 100000004865
MedDRA version: 17.0Level: LLTClassification code 10038286Term: Regional nerve blockSystem Organ Class: 100000004865
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2014-000707-28-DK

Lead Sponsor: Aarhus University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Age > 18 years
major foot and ankle surgery procedures
written informed consent to participate in the suds after having understood the contents of the protocol and limitations fully
for fertile women, a negative HCG-test
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 17
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 17

Exclusion Criteria

- patients who are unable to corporate
- patients that don't understand Danish or English
- patients in immunosupressive treatment
- patients with neuropathy in the lower limb (s)
- patients with known allergies to the drugs involved
- patients with daily opioid intake
- patients who are pregnant
- patients who are unable to meet the MRI criteria

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim is to investigate whether the frequency of displacement of a popliteal perineural catheter for continuous infusion the first 48 hours after major foot and ankle surgery is reduced with longitudinal inserted catheters compared to lateral inserted catheters;Secondary Objective: not applicable;Primary end point(s): Frequency of non-displaced catheters evaluated by perineural spread of local anesthetic by MR/ultrasound image fusion technology 48 hours after insertion of the catheter;Timepoint(s) of evaluation of this end point: 48 hours after catheter insertion

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Effect and durability of sciatic nerve catheters evaluated by cumulated and frequency of rescue-blocks and extent of sensory loss of the foot evaluated by pin-prick sensation;Timepoint(s) of evaluation of this end point: 48 hours