Suspected isolated hip fracture - Clinical suspicion of hip fracture is defined as the presence of painful, unilateral shortening and external rotation of the lower limb preventing weight-bearing. MedDRA version: 8.1 Level: LLT Classification code 10002182 Term: Analgesia
Conditions
Interventions
Trade Name: Marcain
Product Name: Bupivacaine
Pharmaceutical Form: Injection*
INN or Proposed INN: BUPIVACAINE
CAS Number: 2180929
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type:
Sponsors
Nottingham University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All alert and orientated patients presenting to the ED of the University Hospital Nottingham having sustained a suspected isolated hip fracture and willing to be randomised for pain relief as described. Clinical suspicion of hip fracture is defined as the presence of painful, unilateral shortening and external rotation of the lower limb preventing weight-bearing. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Other significant injury Clinical suspicion of fracture other than to the hip Sensitivity to any study preparation Local infection at the injection site Symptoms/Injury >8hours Pre-hospital parenteral analgesia Unable to give informed consent either as a result of current or pre-existing physical or mental condition Known Coagulopathy Patient taking Warfarin or Clopidogrel within 2 weeks BMI >40
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of Bupivacaine as a Fascia Iliaca Compartment Block (FICB) for patients in the emergency department presenting with suspected fractured hip with the current standard analgesia, intravenous morphine sulphate.;Secondary Objective: To investigate the duration of effect, ease of use, failure rates and morphine sparing effect of using FICB in this patient group.;Primary end point(s): Primary outcome measure will be a comparison between the experimental and control groups of the difference in maximum tolerable passive hip flexion from supine (verbal pain score of 3 or less), expressed in degrees measured using a goniometer, at baseline (on arrival after recruitment but prior to randomisation) vs. 45 minutes post-intervention. | — |
Countries
United Kingdom
Outcome results
None listed