Fascia Iliaca Compartment Block for Pain Management in Hip Fracture Patients

Phase 4

Completed

• Conditions: Hip Fractures
• Interventions: 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

• Registration Number: NCT04837924
• Lead Sponsor: General Hospital Sveti Duh

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.

Study Timeline

• Study First Submitted: 2021-03-24
• Study First Submitted QC: 2021-04-07
• Study First Posted: 2021-04-08
• Study Start: 2021-04-21
• Primary Completion: 2022-05-26
• Study Completion: 2022-05-27
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B (FICB)	fascia iliaca compartment block, (FICB) (levobupivacaine hydrochloride 0,25% 40 ml)	Participants receiving fascia iliaca compartment block (FICB)
B (FICB)	Rescue analgesic tramadol 100 mg IV if needed	Participants receiving fascia iliaca compartment block (FICB)
A (PLACEBO)	Rescue analgesic tramadol 100 mg IV if needed	Participants receiving sham injection matching fascia iliaca compartment block (FICB)
A (PLACEBO)	Sham injection	Participants receiving sham injection matching fascia iliaca compartment block (FICB)
B (FICB)	paracetamol 1 gram IV	Participants receiving fascia iliaca compartment block (FICB)
A (PLACEBO)	paracetamol 1 gram IV	Participants receiving sham injection matching fascia iliaca compartment block (FICB)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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"

Trial Locations

Locations (1)

Clinical Hospital "Sveti Duh"; 🇭🇷 Zagreb, Croatia