Project Details
Description
OBJECTIVE/RESEARCH QUESTION
Does an ultrasound guided Fascia Iliaca Compartment Block (FICB) employing an intra-compartmental catheter (continuous FICB, providing continuous anesthesia), applied in the Emergency Department (ED), reduces delirium in elderly hip fracture patients?
HYPOTHESIS
Due to superior and continuous regional pain treatment from a very early starting point in the clinical course, patients experience less pain and require less systemic analgesics. Incidence of delirium during the complete clinical course will decrease
STUDY DESIGN
Prospective open multi-center RCT with follow-up until 3 months after discharge
STUDY POPULATION
Consecutive elderly hip fracture patients (>55 years) presenting to the ED. Exclusion criteria: polytraumatic injuries; delirious state at presentation and inability to provide informed consent. All patients eligible will be asked to participate in the study.
INTERVENTION
Using ultrasound guidance, a continuous FICB is placed in the ED <2 hours after presentation. The catheter placed will remain in place until 2 days after surgery to treat pain continuously by titration of LA
COMPARISON
Usual care (national guideline): opioids, combined with paracetamol and NSAIDs
OUTCOME MEASURES
Primary outcome will be occurrence of delirium during entire hospital admission, until 3 months after discharge. Secondary outcomes will be pain, patient and staff satisfaction regarding analgesic effects and logistics of the allocated pain treatment, hospital stay characteristics, functional, cognitive and generic and specific Health Related Quality of life (HRQol), cost-effectiveness.
SAMPLE SIZE CALCULATION
Based on assumed superiority of a continuous FICB in acute pain management in comparison with usual care, registering a minimal clinically relevant difference of 13% in incidence of delirium, using a 5% significance level and power of 80% and allowing for 10% loss to follow-up, we need to recruit 340 patients
COST-EFFECTIVENESS ANALYSIS / BUDGET IMPACT ANALYSIS (BIA)
We hypothesize that using a continuous FICB in elderly hip fracture patients in the ED is a more tailored approach in acute pain management associated with less health related costs. In addition a BIA will be performed to determine potential financial impact of this more adequate pain strategy for elderly patients with a hip fracture in the ED on national health care costs in the future. This will be based on (clinical) data that reflect size and characteristics of the population, the effectiveness of a continuous FICB and the related resource use and costs
Does an ultrasound guided Fascia Iliaca Compartment Block (FICB) employing an intra-compartmental catheter (continuous FICB, providing continuous anesthesia), applied in the Emergency Department (ED), reduces delirium in elderly hip fracture patients?
HYPOTHESIS
Due to superior and continuous regional pain treatment from a very early starting point in the clinical course, patients experience less pain and require less systemic analgesics. Incidence of delirium during the complete clinical course will decrease
STUDY DESIGN
Prospective open multi-center RCT with follow-up until 3 months after discharge
STUDY POPULATION
Consecutive elderly hip fracture patients (>55 years) presenting to the ED. Exclusion criteria: polytraumatic injuries; delirious state at presentation and inability to provide informed consent. All patients eligible will be asked to participate in the study.
INTERVENTION
Using ultrasound guidance, a continuous FICB is placed in the ED <2 hours after presentation. The catheter placed will remain in place until 2 days after surgery to treat pain continuously by titration of LA
COMPARISON
Usual care (national guideline): opioids, combined with paracetamol and NSAIDs
OUTCOME MEASURES
Primary outcome will be occurrence of delirium during entire hospital admission, until 3 months after discharge. Secondary outcomes will be pain, patient and staff satisfaction regarding analgesic effects and logistics of the allocated pain treatment, hospital stay characteristics, functional, cognitive and generic and specific Health Related Quality of life (HRQol), cost-effectiveness.
SAMPLE SIZE CALCULATION
Based on assumed superiority of a continuous FICB in acute pain management in comparison with usual care, registering a minimal clinically relevant difference of 13% in incidence of delirium, using a 5% significance level and power of 80% and allowing for 10% loss to follow-up, we need to recruit 340 patients
COST-EFFECTIVENESS ANALYSIS / BUDGET IMPACT ANALYSIS (BIA)
We hypothesize that using a continuous FICB in elderly hip fracture patients in the ED is a more tailored approach in acute pain management associated with less health related costs. In addition a BIA will be performed to determine potential financial impact of this more adequate pain strategy for elderly patients with a hip fracture in the ED on national health care costs in the future. This will be based on (clinical) data that reflect size and characteristics of the population, the effectiveness of a continuous FICB and the related resource use and costs
| Acronym | DEPTHip Study |
|---|---|
| Status | Active |
| Effective start/end date | 1/05/2016 → … |