Fascia Iliaca Compartment Block for Pain Management in Hip Fracture Patients

Hip Fractures Clinical Trial

— BLOCKPAIN  

Official title:

The Effects of Fascia Iliaca Compartment Block on Hip Fracture Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04837924
• Other study ID #: 0121812
• Status: Completed
• Phase: Phase 4
• Start date: April 21, 2021
• Est. completion date: May 27, 2022

Study information

• Verified date: August 2022
• Source: General Hospital Sveti Duh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 27, 2022
• Est. primary completion date: May 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

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

Drug:
• paracetamol 1 gram IV
paracetamol 1 gram IV every six hours, 4 times in 24 hours
• Rescue analgesic tramadol 100 mg IV if needed
Rescue analgesic, if needed, tramadol 100 mg in 100 ml saline (0,9% Sodium chloride) IV, up to 4 times in 24 hours

Procedure:
• Sham injection
Sting with blunt needle, (without piercing the skin), same site as fascia iliaca compartment block

Locations

Country	Name	City	State
Croatia	Clinical Hospital "Sveti Duh"	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital Sveti Duh

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stress Response 1	cortisol plasma level	Change from baseline cortisol plasma level at 24 hours
Primary	Stress Response 2	copeptin plasma level	Change from baseline copeptin plasma level at 24 hours
Primary	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	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