Fascia Iliaca Compartment Block for Pain Management in Hip Fracture

Status Completed

Clinical Trial Summary

BLOCKPAIN is a randomized controlled study, 80 participants. The participants will be hip fracture patients in Emergency Medicine Department in Clinical Hospital "Sveti Duh", Zagreb, Croatia. Upon patient arrival inclusion and exclusion criteria will be established. After signing the informed consent form participant will be randomized in one of two study groups. One study group is fascia iliaca compartment block (FICB), the other is placebo. All participants will be given paracetamol 1 gram IV as standard care. If needed, rescue analgesic will be tramadol 100 mg in 100 ml saline IV. The time frame is 24 hours after the FICB or placebo procedure.

Clinical Trial 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 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04837924
Study type	Interventional
Source	General Hospital Sveti Duh
Contact
Status	Completed
Phase	Phase 4
Start date	April 21, 2021
Completion date	May 27, 2022

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Fascia Iliaca Compartment Block for Pain Management in Hip Fracture Patients — BLOCKPAIN

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms