Fascia Iliaca Compartment Block for Pain Management in Hip Fracture Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hip Fractures
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 80 participants, stratified randomization will be used, men/women, age 65-75 years/older then 75 years, The American Society of Anesthesiologists physical status classification, (ASA status) I-II/ ASA III and IV, and type of hip fracture intra/extracapsularMasking: Triple (Participant, Care Provider, Outcomes Assessor)Masking Description: Participants will be blinded by sham procedure (disinfection, sting with blunt needle, (without piercing the skin), in the groin area, same place where actual FICB is given and covered with same gauze/patch). It will not be revealed to care providers and outcome measurement associate in which group participant is. After the data collection statistical analyst will not know is A group experimental or control.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 65 years and 125 years
- Gender
- Both males and females
Description
Hip fractures in older patients are a major public health problem. For acute pain management, nonopioid analgesics are often not sufficient enough, and opioids have many adverse events. For this reasons fascia iliaca compartment block could be the treatment of choice. The objective of this study is ...
Hip fractures in older patients are a major public health problem. For acute pain management, nonopioid analgesics are often not sufficient enough, and opioids have many adverse events. For this reasons fascia iliaca compartment block could be the treatment of choice. The objective of this study is to evaluate the efficacy of the fascia iliaca compartment block for pain management in the emergency department, especially the effect on stress response and the effect on the acute confusional state. The investigators intend to conduct a randomized clinical trial in hip fracture patients years 65 and older presenting in the emergency department. In addition to standard analgesia with parenteral paracetamol, the first group of patients will receive fascia iliaca compartment block and the second group placebo. The investigators will monitor the effect of treatment protocol on laboratory parameters of stress response copeptin and cortisol, frequency and severity of acute confusional state, pain intensity and the need for additional opioid analgesics. Data obtained from this research could significantly improve the standard and quality of analgesia in the older patients with hip fracture. Regional anesthesia can diminish or prevent the development of stress response and cognitive impairment and these are the factors that complicate recovery of this fragile group of patients.
Tracking Information
- NCT #
- NCT04837924
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: An?ela Simi? Clinical Hospital "Sveti Duh"
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