Fascia Iliaca Compartment Block for Pain Management in Hip Fracture Patients

NCT04837924 | Completed Phase 4

• 1 other identifier: 0121812
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Fractures

Keywords

Hip Fractures; Pain Management

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Pain Intensity

  Immediately prior and 30, 120, 240 minutes and 24 hours

Study Arms (2)

B (FICB)

EXPERIMENTAL

Participants receiving fascia iliaca compartment block (FICB)

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

A (PLACEBO)

SHAM COMPARATOR

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

Drug: paracetamol 1 gram IV; Drug: Rescue analgesic tramadol 100 mg IV if needed; Procedure: Sham injection

Interventions

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.

B (FICB)

paracetamol 1 gram IV DRUG

paracetamol 1 gram IV every six hours, 4 times in 24 hours

A (PLACEBO); B (FICB)

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

A (PLACEBO); B (FICB)

Sham injection PROCEDURE

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

A (PLACEBO)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• General Hospital Sveti Duh: lead

Study Sites (1)

Clinical Hospital "Sveti Duh"

Zagreb, 10 000, Croatia

Location

MeSH Terms

Conditions

Hip Fractures; Agnosia

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

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

Study Officials

• Anđela Simić

  Clinical Hospital "Sveti Duh"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded by sham procedure (disinfection, sting with blunt needle, (without piercing the skin), in the groin area, same place where actual FICB is given and covered with same gauze/patch). It will not be revealed to care providers and outcome measurement associate in which group participant is. After the data collection statistical analyst will not know is A group experimental or control.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 80 participants, stratified randomization will be used, men/women, age 65-75 years/older then 75 years, The American Society of Anesthesiologists physical status classification, (ASA status) I-II/ ASA III and IV, and type of hip fracture intra/extracapsular

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: April 8, 2021
• Study Start: April 21, 2021
• Primary Completion: May 26, 2022
• Study Completion: May 27, 2022
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months after the study publication, unlimited
• Access Criteria: The de-identified IPD will be available for research purposes by contacting the first author via e-mail.

Locations

CR (1)