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

The Effects of Fascia Iliaca Compartment Block on 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.

Study Overview

• Status: Completed
• Conditions: Hip Fractures
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Croatia
  • Zagreb, Croatia, 10 000
    • Clinical Hospital "Sveti Duh"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: B (FICB); Participants receiving fascia iliaca compartment block (FICB)	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; Drug: 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
Sham Comparator: A (PLACEBO); Participants receiving sham injection matching fascia iliaca compartment block (FICB)	Drug: paracetamol 1 gram IV; paracetamol 1 gram IV every six hours, 4 times in 24 hours; Drug: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: General Hospital Sveti Duh
• Investigators: Principal Investigator: Anđela Simić, Clinical Hospital "Sveti Duh"

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2021
• Primary Completion (Actual): May 26, 2022
• Study Completion (Actual): May 27, 2022

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: April 7, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Pain Management; Hip Fractures
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Antipyretics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Acetaminophen; Tramadol; Levobupivacaine; Analgesics
• Other Study ID Numbers: 0121812

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All IPD will be shared on demand, via Principal Investigator e-mail. There is a prior signed consent of all participants.
• IPD Sharing Time Frame: 6 months after the study publication, unlimited
• IPD Sharing Access Criteria: The de-identified IPD will be available for research purposes by contacting the first author via e-mail.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No