Hip Fractures
Conditions
Keywords
Hip Fractures, Pain Management
Brief 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.
Detailed 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.
Interventions
PROCEDUREfascia iliaca compartment block, (FICB) (levobupivacaine hydrochloride 0,25% 40 ml)
Land mark technique will be used to perform FICB on the side of the hip fracture. The injection site is one centimetre caudal from the junction between medial 2/3 and lateral 1/3 in the imaginary line between anterior superior iliac spine and ipsilateral pubic tubercle. The goal is to administer local anesthetic in the fascia iliaca compartment.
DRUGparacetamol 1 gram IV
paracetamol 1 gram IV every six hours, 4 times in 24 hours
DRUGRescue analgesic tramadol 100 mg IV if needed
Rescue analgesic, if needed, tramadol 100 mg in 100 ml saline (0,9% Sodium chloride) IV, up to 4 times in 24 hours
PROCEDURESham injection
Sting with blunt needle, (without piercing the skin), same site as fascia iliaca compartment block
Sponsors
General Hospital Sveti Duh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, 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.
Intervention 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/extracapsular
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* hip fracture after minor trauma/simple falls, confirmed by imaging technique (X-ray or CT scan or MRI) * signed informed consent form (after a verbal explanation and written information sheet)
Exclusion criteria
* pathological fracture * head injury * body mass bellow 50 kg * cognitive impairment (Abbreviated Mental Test Score less then 6 points) * oral anticoagulant drugs * prior drug allergy (paracetamol, tramadol, local anesthetics) * prior peripheral artery bypass surgery (on the same side as hip fracture) * skin or soft tissue infection in the groin area (on the same side as hip fracture) * simultaneously bilateral hip fracture * opioid analgesics prior to hospital arrival
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stress Response 1 | Change from baseline cortisol plasma level at 24 hours | cortisol plasma level |
| Stress Response 2 | Change from baseline copeptin plasma level at 24 hours | copeptin plasma level |
| Acute confusional state/Delirium | Change from baseline Abbreviated Mental Test Score at 24 hours | Abbreviated Mental Test Score (AMTS) - 10 point scale, from 0 to 10, 10 is the best possible result, 2 and more point drop from baseline indicating delirium |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | Immediately prior and 30, 120, 240 minutes and 24 hours | Pain intensity at rest and pain intensity at movement, Numerical Rating Scale (NRS), from 0 to 10, 0 meaning no pain and 10 the worst pain ever possible |
Countries
Croatia
Outcome results
None listed