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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02200016
Enrollment
40
Registered
2014-07-25
Start date
2014-11-30
Completion date
2015-05-31
Last updated
2015-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain, Regional Anesthesia

Keywords

Postoperative pain, Regional anesteshia, Nerve catheters, Sciatic nerve catheters

Brief summary

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

Interventions

PROCEDUREUltrasound 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.

PROCEDUREUltrasound 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.

DEVICEB Braun Contiplex S catheter

Sponsors

Aarhus University Hospital
CollaboratorOTHER
Kolding Sygehus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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...)

Design outcomes

Primary

MeasureTime frame
Frequency of nerve catheter displacement48 hours after catheter placement

Secondary

MeasureTime frame
Opioid comsumptionWithin first 48 hours postoperatively
Number of rescue blocksWithin 48 hours postoperatively
Postoperativ pain after local anesthetic injection via sciatic nerve catheterWithin 48 hours postoperatively
MR evaluated distribution of local anesthetic after injection MR-contrast48 hours after catheter placement

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026