Fascia Iliaca Compartment Block for Pain Management in Hip Fracture Patients

NCT ID: NCT04837924

Last Updated: 2022-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-21
• Study Completion Date: 2022-05-27

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.

Conditions

Hip Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

B (FICB)

Participants receiving fascia iliaca compartment block (FICB)

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

paracetamol 1 gram IV

Intervention Type: DRUG

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

Rescue analgesic tramadol 100 mg IV if needed

Intervention Type: 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)

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

Group Type: SHAM_COMPARATOR

paracetamol 1 gram IV

Intervention Type: DRUG

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

Rescue analgesic tramadol 100 mg IV if needed

Intervention Type: DRUG

Rescue analgesic, if needed, tramadol 100 mg in 100 ml saline (0,9% Sodium chloride) IV, up to 4 times in 24 hours

Sham injection

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

paracetamol 1 gram IV

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

Intervention Type: 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

Intervention Type: DRUG

Sham injection

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General Hospital Sveti Duh

OTHER

Sponsor Role: lead

Responsible Party

Andela Simic

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anđela Simić

Role: PRINCIPAL_INVESTIGATOR

Clinical Hospital "Sveti Duh"

Locations

Clinical Hospital "Sveti Duh"

Zagreb, , Croatia

Countries

Croatia

Other Identifiers

0121812

Identifier Type: -

Identifier Source: org_study_id