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Completed

NCT Number: NCT04837924

Fascia Iliaca Compartment Block for Pain Management in Hip Fracture Patients

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.

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Key information

Conditions

Hip Fractures Agnosia Femoral Fractures Fractures, Bone Hip Injuries Leg Injuries Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Wounds and Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinical Hospital "Sveti Duh"

Zagreb, 10 000, Croatia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Sham injection

Procedure

Sting with blunt needle, (without piercing the skin), same site as fascia iliaca compartment block

Primary outcomes

  1. Stress Response 1

    Time frame: Change from baseline cortisol plasma level at 24 hours

    cortisol plasma level

  2. Stress Response 2

    Time frame: Change from baseline copeptin plasma level at 24 hours

    copeptin plasma level

  3. Acute confusional state/Delirium

    Time frame: 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 outcomes

  1. Pain Intensity

    Time frame: 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"

Sponsors and collaborators

Lead sponsor

General Hospital Sveti Duh

Other

Registry information

Official study title

The Effects of Fascia Iliaca Compartment Block on Hip Fracture Patients

Acronym: BLOCKPAIN

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 8, 2021
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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