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: 17.0 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 100000004865 MedDRA version: 17.0 Level: LLT Classification code 10038286 Term: Regional nerve block System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Dotarem
Product Name: Dotarem
Product Code: V 08 CA 02
Pharmaceutical Form: Solution for injection
INN or Proposed INN: GADOTERIC ACID
CAS Number: 72573-82-1
Current Sponsor code: V 08 CA
Sponsors
Aarhus University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Denmark
Contacts
Public ContactDepartment of Anesthesia
Aarhus University Hospital
Outcome results
None listed