NCT02433548.
Trial name or title | Fascia iliaca block in the emergency department for analgesia after femoral neck fracture |
Methods | Parallel RCT Double‐blind (caregiver, investigator, outcome assessor) |
Participants | Inclusion criteria: adults (≥ 18 years) with femoral neck fracture in the emergency department Exclusion criteria: presence of dementia, body weight < 40 kg, presence of cancer or receiving chemotherapy, allergy to local anaesthetics |
Interventions |
Treatment group: fascia iliaca block (injection of 30 mL of bupivacaine 0.5% with epinephrine 5 mcg/mL below the fascia iliaca, Carbostesin®) Control group: sham injection = subcutaneous injection of 5 mL of normal saline |
Outcomes | Primary outcome measures: pain scores at rest: 45 minutes after injection Secondary outcome measures: pain scores at rest at 60 minutes, 4 hours, 8 hours, 12 hours and 24 hours after injection; pain scores on movement:at 60 minutes, 4 hours, 8 hours, 12 hours and 24 hours after injection; morphine consumption at 60 minutes, 4 hours, 8 hours, 12 hours and 24 hours after injection and length of stay |
Starting date | October 2014 |
Contact information | Eric Albrecht, Program Director, Regional Aanaesthesia, CHU Vaudois, Switzerland |
Notes | Recruiting |
AMTS: Abbreviated 10‐point Mental Test Score
ASA: American Society of Anaesthesiologists physical status
C: Celsius
CAM Questionnaire: Confusion Assessment Method
EQ‐5D or EUROQOL: score for measurement of health‐related quality of life
G: gram
ICD‐9: list of codes for International Statistical Classification of Diseases and Related Health Problems
IV: intravenous
kg: kilogram
kg/m2: kilogram per square metre
mm: millimetre
MSMC ED: Maimonides Medical Center emergency department
n: number
NHS: Nottingham University Hospitals
OMC: orientation‐memory‐concentration
RCT: randomized controlled trial
RfPB: Research for Patient Benefit