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

General Hospital Sveti Duh

Status and phase: Completed; Phase 4

Conditions: Hip Fractures

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04837924

0121812

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

B (FICB)

Experimental group

Description:

Participants receiving fascia iliaca compartment block (FICB)

Treatment:

Drug: Rescue analgesic tramadol 100 mg IV if needed

Procedure: fascia iliaca compartment block, (FICB) (levobupivacaine hydrochloride 0,25% 40 ml)

Drug: paracetamol 1 gram IV

A (PLACEBO)

Sham Comparator group

Description:

Participants receiving sham injection matching fascia iliaca compartment block (FICB)

Treatment:

Drug: Rescue analgesic tramadol 100 mg IV if needed

Procedure: Sham injection

Drug: paracetamol 1 gram IV