Fascia Iliaca Compartment Block for Pain Management in Hip Fracture Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effects of Fascia Iliaca Compartment Block on Hip Fracture Patients

Conditions
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Hip Fractures

Intervention / Treatment
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* Procedure: fascia iliaca compartment block, (FICB) (levobupivacaine hydrochloride 0,25% 40 ml)
* Drug: paracetamol 1 gram IV
* Drug: Rescue analgesic tramadol 100 mg IV if needed
* Procedure: Sham injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B (FICB)<br>Participants receiving fascia iliaca compartment block (FICB) | Procedure: fascia iliaca compartment block, (FICB) (levobupivacaine hydrochloride 0,25% 40 ml)<br>* 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.<br>Drug: paracetamol 1 gram IV<br>* paracetamol 1 gram IV every six hours, 4 times in 24 hours<br>Drug: Rescue analgesic tramadol 100 mg IV if needed<br>* Rescue analgesic, if needed, tramadol 100 mg in 100 ml saline (0,9% Sodium chloride) IV, up to 4 times in 24 hours<br>|
| Sham Comparator: A (PLACEBO)<br>Participants receiving sham injection matching fascia iliaca compartment block (FICB) | Drug: paracetamol 1 gram IV<br>* paracetamol 1 gram IV every six hours, 4 times in 24 hours<br>Drug: Rescue analgesic tramadol 100 mg IV if needed<br>* Rescue analgesic, if needed, tramadol 100 mg in 100 ml saline (0,9% Sodium chloride) IV, up to 4 times in 24 hours<br>Procedure: Sham injection<br>* Sting with blunt needle, (without piercing the skin), same site as fascia iliaca compartment block<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip Fractures, Pain Management