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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B (FICB) | Experimental | Participants receiving fascia iliaca compartment block (FICB) |
|
| A (PLACEBO) | Sham Comparator | Participants receiving sham injection matching fascia iliaca compartment block (FICB) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fascia iliaca compartment block, (FICB) (levobupivacaine hydrochloride 0,25% 40 ml) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Stress Response 1 | cortisol plasma level | Change from baseline cortisol plasma level at 24 hours |
| Stress Response 2 | copeptin plasma level | Change from baseline copeptin plasma level at 24 hours |
| Acute confusional state/Delirium | 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 | Change from baseline Abbreviated Mental Test Score at 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | 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" | Immediately prior and 30, 120, 240 minutes and 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anđela Simić | Clinical Hospital "Sveti Duh" | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Hospital "Sveti Duh" | Zagreb | 10 000 | Croatia |
All IPD will be shared on demand, via Principal Investigator e-mail. There is a prior signed consent of all participants.
6 months after the study publication, unlimited
The de-identified IPD will be available for research purposes by contacting the first author via e-mail.
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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
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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.
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| paracetamol 1 gram IV | Drug | paracetamol 1 gram IV every six hours, 4 times in 24 hours |
|
| Rescue analgesic tramadol 100 mg IV if needed | Drug | Rescue analgesic, if needed, tramadol 100 mg in 100 ml saline (0,9% Sodium chloride) IV, up to 4 times in 24 hours |
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| Sham injection | Procedure | Sting with blunt needle, (without piercing the skin), same site as fascia iliaca compartment block |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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