Ankle fracture (anaesthesia for surgery) MedDRA version: 18.0 Level: LLT Classification code 10054865 Term: Malleolar fracture System Organ Class: 100000004863
Conditions
Interventions
Trade Name: Ropivacain "Fresenius Kabi" 7,5 mg/ml
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ROPIVACAINE HYDROCHLORIDE
Other descriptive name: ROPIVACAINE HYDROCHLORIDE
Concentra
Sponsors
Herlev Hospital, Department of Anaesthesiology I65N9
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients > 18 years old scheduled for internal fixation of an ankle fracture (malleolar fracture). - Ability to read and understand Danish and give informed oral and written 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: - Allergy towards any drug in trial protocol - Bodyweight < 52 kg - Contraindications for SA according to national guidelines - Current gastro-intestinal bleeding - Proximal fibular fracture or multitrauma/other fractures - Cognitive or psychiatric dysfunction or alcohol/narcotic substance abuse causing expected inability to comply with study protocol as evaluated by anaesthesiologist/investigator - No available anaesthesiologist with PNB capability at scheduled time of operation - Neuropathy / neurological dysfunction in the lower extremities - Habitual daily use of opioids - Pregnancy (known or suspected) or breastfeeding - Infection at anaesthesia injection site - Nephropathy requiring dialysis - Acute porphyria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study difference in combined short term postoperative pain and opioid use following peripheral nerve block (PNB) anaesthesia versus spinal anaesthesia (SA) for ankle fracture surgery.;Secondary Objective: To compare the following parameters in the two trial groups: - Difference in rebound pain following cessation of PNB versus SA. - Postoperative opioid related adverse effects. - Patient experienced satisfaction and quality of recovery. - Adverse events. - Pain and opioid need day 2-7 postoperatively. ;Primary end point(s): • Difference between the anaesthesia groups in Integrated Pain Score (IPS) for the period 0-27 hours post-anaesthesia. IPS is based on Numeric Rating Scale pain score Area Under the Curve (NRS-AUC) and total morphine consumption.;Timepoint(s) of evaluation of this end point: 27 hours post-anaesthesia. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Difference between anaesthesia groups regarding: 1) Rebound pain: NRS-AUC pain for a 6-hour period from patient-reported time of cessation of sensory block (PNB or spinal). 2) NRS-AUC pain 0-27 hours post-anaesthesia. 3) Morphine use 0-27 hours (PCA pump) 4) Opioid adverse effects 0-27 hours = Clinically Meaningful Events (CME) assessed by the OR-SDS score 5) Quality of Recovery (QoR-15 score) 0-27 hours 6) “Risk patients” i.e. number of patients with IPS +100 to +200 (= high pain and high morphine consumption) 7) Peak NRS pain score 0-27 hours 8) “High pain patients” i.e. number of patients reaching peak NRS = 7 9) NRS pain scores postoperative (PO) days 2-7 10) Need for on demand opioids PO day 2-7 11) Opioid adverse effects PO day 2 = CMEs assessed by the composite OR-SDS score 12) Overall patient satisfaction with anaesthesia, NRS-score 13) Postoperative nerve symptoms on PO day 7 14) Number of adverse events / adverse reactions registered;Timepoint(s) of evaluation of this end point: 1-8) 27 hours post-anaesthesia 9, 10, 12, 13) Postoperative day 7 11) Postoperative day 2 14) 20 hours post-anaesthesia | — |
Countries
Denmark
Contacts
Public ContactDepartment of Anaesthesiology I65N9
Herlev Hospital
Outcome results
None listed