A 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
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 239
- 试验地点
- 5
- 主要终点
- occurrence of delirium
研究概览
简要总结
A broken hip occurs frequently in elderly patients and is often very painful. Side effects of inadequately treated pain as well as the traditional drugs (administered through intravenous catheter) used to treat pain are, among others, a confusional state, called delirium. When pain medication is administered locally, only around the hip joint, pain might be treated more effectively and these side effects could be prevented. This is called a nerve block.
The current study evaluates the use of a continuous nerve block throughout the complete hospital admission with a catheter around the hip joint versus the use of traditionally used pain medication administered though an intravenous catheter in elderly patients with a broken hip. Half of all patients will receive the nerve block while in the emergency department and the other half will receive pain medication through the intravenous access.
详细描述
BACKGROUND Hip fractures occur frequently and are usually very painful. Pain itself is an indicator for increased risk of complications. A significant 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 (with increased intrinsic risk of developing delirium) 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 (occurrence 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%. Superiority of the FICB versus usual care will be tested using the Chi Square Test. In order to detect a clinically relevant between-group-difference of 13% decrease in incidence, a significance level of 0.05 and 80% power will be used. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients aged ≥ 55 years with
- •a radiographically confirmed hip fracture
排除标准
- •multiple injuries (polytrauma patients)
- •previous adverse reaction or known allergy to local anaesthetics or opioids or paracetamol
- •skin infection in proximity of injection site
- •delirious state at presentation in the ED
研究组 & 干预措施
Continuous FICB with local anesthetics
With ultrasound guidance, a Fascia Iliaca Compartment Block 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% or equipotent dosages of levobupivacaine or ropivacaine. Thereafter, until removal of the catheter, pain is treated by titrating local anesthetics according to pain scores.
干预措施: Bupivacaine (Drug)
Continuous FICB with local anesthetics
With ultrasound guidance, a Fascia Iliaca Compartment Block 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% or equipotent dosages of levobupivacaine or ropivacaine. Thereafter, until removal of the catheter, pain is treated by titrating local anesthetics according to pain scores.
干预措施: Levobupivacaine (Drug)
Continuous FICB with local anesthetics
With ultrasound guidance, a Fascia Iliaca Compartment Block 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% or equipotent dosages of levobupivacaine or ropivacaine. Thereafter, until removal of the catheter, pain is treated by titrating local anesthetics according to pain scores.
干预措施: Ropivacaine (Drug)
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.
干预措施: Acetaminophen (Drug)
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.
干预措施: Diclofenac (Drug)
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.
干预措施: Ibuprofen (Drug)
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.
干预措施: Naproxen (Drug)
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.
干预措施: Dipyrone (Drug)
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.
干预措施: Fentanyl (Drug)
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.
干预措施: Morphine (Drug)
结局指标
主要结局
occurrence of delirium
时间窗: three months
Diagnosis will be based on DSM-IV criteria. During hospital admission screening is actively. After discharge, information is gathered by contacting patients and family members, general practitioners or nursing facilities
次要结局
- patient satisfaction(from hospital admission until 48 hours after surgery)
- length of hospital stay(from hospital admission until discharge; an average of 9 days)
- ICU admission(from hospital admission until discharge; an average of 9 days)
- ICU length of stay(from hospital admission until discharge; an average of 9 days)
- hospital re-admission rate(three months)
- medical complications(three months)
- surgical complications(three months)
- mortality(three months)
- activities of daily living(three months)
- generic quality of life(three months)
- Oxford hip score(three months)
- cognitive function with Mini Mental State Examination(three months)
- cost effectiveness analysis(three months)
- duration of delirium(three months)
- severity of delirium(three months)
- NRS pain scores(from hospital admission until 48 hours after surgery)
- need for additional analgesia(hospital admission until 48 hours after surgery)
研究者
Milan Ridderikhof
MD PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)