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van CCT (UK)

DEPTHip Study: Delirium in Elderly Patients with Trauma of the Hip

- candidate number23935
- NTR NumberNTR5747
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-feb-2016
- Secondary IDsNL54580.018.15 METC Academisch Medisch Centrum
- Public TitleDEPTHip Study: Delirium in Elderly Patients with Trauma of the Hip
- Scientific TitleA Multicenter Randomized Controlled Trial in Elderly Patients With Hip Fractures Comparing Continuous Fascia Iliaca Compartment Block to Systemic Opioids and Its Effect on Delirium Occurrence
- ACRONYMDEPTHip Study (Delirium in Elderly Patients with Trauma of the Hip)
- hypothesisA continuous Fascia Iliaca Compartment Block (FICB) initiated in the Emergency Department and continued throughout the complete hospital admission employing catheter technique will decrease the incidence of delirium in elderly patients with hip fractures compared to traditional care with systemic opioids.
- Healt Condition(s) or Problem(s) studiedHip fractures, Nerve block, Anesthesia, Analgesia, Older adults
- Inclusion criteria1. Adult patients aged ≥ 55 years
2. A radiographically confirmed hip fracture
- Exclusion criteria1. Multiple injuries (polytrauma patients)
2. Previous adverse reaction or known allergy to local anaesthetics or opioids or paracetamol
3. Skin infection in proximity of injection site
4. Delirious state at presentation in the ED
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2016
- planned closingdate1-aug-2018
- Target number of participants340
- InterventionsPatients are randomized on a 1:1 ratio to one of the following:

1. Continuous FICB with bupivacaine
With ultrasound guidance, a FICB will be administered and a catheter left in the compartment underneath the iliac fascia. This catheter will remain in place until two days after surgery. Initial pain treatment in the Emergency Department will be with 40 mL bupivacaine 0.25%. Thereafter, until removal of the catheter, pain is treated by titrating bupivacaine 0.125% with a daily maximum of 400 mg.

2. Traditional care with systemic analgesia.
Traditional care (usual care) will be on the discretion of the treating physician or hospital protocols and will comprise of systemic opioids such as fentanyl or morphine. Usually, these opioids are combined with several other drugs, such as: paracetamol, NSAIDs (diclofenac or ibuprofen or naproxen) or dipyrone. (Inter)national guidelines advice morphine as first line agent in elderly patients with hip fractures, as longer acting analgesics are usually required.
- Primary outcomeOccurrence of delirium
- Secondary outcome- Duration and severity of delirium
- Pain and need for additional analgesia
- Hospital characteristics (Length of stay, ICU admission and ICU length of stay, hospital re-admission rate, occurrence of complications of hip surgery and medical complications, all cause in-hospital-mortality and mortality after hospital discharge)
- Functional status (15-item modified Katz Index of Activities of Daily Living; Oxford Hip Score; Generic HRQol (Euroqol - EQ-5D-5L); Cognitive function (Mini Mental State Examination))
- Economic evaluation
- TimepointsThree phases:
Phase 1: pain management in the Emergency Department until admission in the hospital
Phase 2: hospital admission; divided in pre-preoperative and post-operative phase)
Phase 3: after hospital discharge until three months after discharge
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publicationsn/a
- Brief summaryBACKGROUND Hip fractures occur frequently and are usually very painful. Pain itself is an indicator for increased risk of complications. A complication is delirium, occurring in up to 25% of all elderly patients with hip fractures. For a large proportion, triggers for development of delirium reaches back to the preoperative phase, where polypharmacy (including opioid use) and inadequately treated pain are major risk factors. Delirium is associated with negative health consequences, increased hospital stay, falls, higher mortality, decreased physical and cognitive function, re-hospitalization, increased risk of dementia and increased societal costs. Therefore, pain should be optimally treated as soon as possible, however the elderly patient poses a challenge in good pain treatment, because of physiological age-related changes, different drug effects, distribution, metabolism and elimination. Opioids frequently lead to respiratory depression, hypotension, nausea/vomiting and sedation in this vulnerable patient group. As a consequence, these drugs are often under dosed and pain treated insufficiently. Besides, drugs as opioids and NSAIDs have been associated with an increased delirium risk. A nerve block could alleviate these clinical issues. An example of a nerve block frequently utilized in the Emergency Department (ED) is a Fascia Iliaca Compartment Block (FICB), in which local anesthetics are injected underneath the pelvic iliac fascia in order to block femoral, obturator and lateral cutaneous nerves to provide anesthesia of hip, thigh and knee. Case-series and historically controlled cohort studies show a single-shot FICB is a rapid, safe and easy procedure providing excellent analgesia, decreased opioid need and little risk of complications. Delirium as outcome was reported in one RCT; a decreased delirium incidence after using repetitive, blind, single-shot FICBs (not in the acute setting) with pethidine (deliriogenic properties) as comparison. In order to prevent the need for repetitive insertions, leaving a catheter would create a route in order to provide continuous analgesia with local anesthetics. Two case series describe this continuous FICB in hip fractures and reported good pain control and decreased length of hospital stay without any infectious complications. No comparison studies have been done with a continuous FICB.

The objective of the current study is to investigate whether the use of a continuous FICB, started early (in the ED) and continued throughout the complete clinical course of a hip fracture, will decrease occurrence of delirium in elderly patients with hip fractures.

METHODS This study is designed as a prospective, open, multi-center, randomized interventional trial. Patients will be allocated to continuous FICB or care as usual (according to national guidelines) in a 1:1 ratio and followed up until three months after hospital discharge.

SAMPLE SIZE AND DATA ANALYSIS The primary outcome (occurence of delirium) is expected to be distributed normally. Although evidence to prevent delirium is scarce, an absolute reduction of 13% incidence has been reported previously after an intervention. The estimated delirium incidence according to literature is 25%. The hypothesis is that by using a continuous FICB administered very early in the clinical course in the ED, the incidence can be decreased from 25 to 12%. We will test superiority of the FICB versus usual care with the Chi Square Test. We will use a significance level of 0.05 and 80% power to detect a clinically relevant between group difference of 13% decrease in incidence. For this analysis, each group will have 154 patients. When accounting for 10% loss to follow-up after three months, a total study population of 340 will be needed. The primary analysis will be based on the intention to treat principle. Per protocol analysis will be performed to check robustness of results. Baseline characteristics will be presented using descriptive statistics. Ordinal data will be analysed using Chi Square Test or Fisher exact test. Continuous data will be assessed by a Student's t-test if normally distributed or Mann Whitney U test if otherwise. Missing data will be corrected by multiple imputation. An economic evaluation will be performed focusing on possible gained benefits of pain management with a continuous FICB compared to care as usual and the related health care costs. The economic evaluation will be performed from a societal perspective with a time horizon of three months and capturing the value of all resources utilized. The economic evaluation will be set up as a Cost-Effectiveness Analysis (CEA). Besides a CEA, a Budget Impact Analysis (BIA) will be performed according to the ISPOR Task Force principles.
- Main changes (audit trail)
- RECORD9-feb-2016 - 23-mei-2016

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