Major ankle and hindfoot surgery MedDRA version: 20.0 Level: LLT Classification code 10038286 Term: Regional nerve block System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Marcain-adrenalin
Product Name: Marcain-adrenalin
Product Code: N 01 BB 01
Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion
INN or Proposed INN: Bupivacaine
Sponsors
Aarhus University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Major ankle and hindfoot surgery Age older than 18 years ASA I-III Informed consent 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Patients who can not cooperate with the investigation. Patients who do not speak and understand Danish Allergy to drugs used in the study Diabetis mellitus Chronic pain (and daily opioid usage) Pregnancy Fertile women, who do not use contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of the study is to demonstrate that repetitive nerveblockade with a protracted mixture of local anesthetic can provide postoperative analgesia for 48 h after major ankle and hindfoot surgery;Secondary Objective: Non applicable;Primary end point(s): Cumulated opioid usage 48 h postoperatively;Timepoint(s) of evaluation of this end point: 48 h postoperative | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time to first opioid usage because of pain (NRS > 3) NRS score 0, 6, 12, 24 and 48 h postoperatively PONV score 0, 6, 12, 24 and 48 h postoperatively Number of vomiting;Timepoint(s) of evaluation of this end point: 48 h postoperatively | — |
Countries
Denmark
Contacts
Public ContactDepartment of Anesthesiology
Kolding Hospital
Outcome results
None listed