Hip FracturesPhase 4BLOCKPAINNCT04837924
Fascia Iliaca Compartment Block for Pain Management in Hip Fracture Patients
A Phase 4 study testing fascia iliaca compartment block, (FICB) (levobupivacaine hydrochloride 0,25% 40 ml), paracetamol 1 gram IV and Rescue analgesic tramadol 100 mg IV if needed in people with Hip Fractures, run by General Hospital Sveti Duh at 1 site in Croatia.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- fascia iliaca compartment block, (FICB) (levobupivacaine hydrochloride 0,25% 40 ml), paracetamol 1 gram IV and Rescue analgesic tramadol 100 mg IV if needed
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteCroatia
- Study dates
- 21 Apr 2021to 27 May 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- fascia iliaca compartment block, (FICB) (levobupivacaine hydrochloride 0,25% 40 ml), paracetamol 1 gram IV, Rescue analgesic tramadol 100 mg IV if needed, Sham injection
- Keywords
- Hip Fractures, Pain Management
- Medical subject headings
- Hip Fractures, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fascia iliaca compartment block, (FICB) (levobupivacaine hydrochloride 0,25% 40 ml)Procedure or surgery
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 IVDrug
paracetamol 1 gram IV every six hours, 4 times in 24 hours
Rescue analgesic tramadol 100 mg IV if neededDrug
Rescue analgesic, if needed, tramadol 100 mg in 100 ml saline (0,9% Sodium chloride) IV, up to 4 times in 24 hours
Sham injectionProcedure or surgery
Sting with blunt needle, (without piercing the skin), same site as fascia iliaca compartment block
| Study group | Role | What they receive |
|---|---|---|
| B (FICB) | Experimental | Participants receiving fascia iliaca compartment block (FICB) Receives: 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) Receives: Drug: paracetamol 1 gram IV; Drug: Rescue analgesic tramadol 100 mg IV if needed; Procedure: Sham injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress Response 1
cortisol plasma level
Measured: Change from baseline cortisol plasma level at 24 hours
Stress Response 2
copeptin plasma level
Measured: 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
Measured: Change from baseline Abbreviated Mental Test Score at 24 hours
Secondary outcomes (1)
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"
Measured: Immediately prior and 30, 120, 240 minutes and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start21 Apr 2021
- Primary completion26 May 2022
- Study completion27 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital Sveti Duh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andela Simic, General Hospital Sveti Duh
- Investigators
- Anđela Simić, Principal investigator, Clinical Hospital "Sveti Duh"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837924
- Sponsor's protocol ID
- 0121812
- Acronym
- BLOCKPAIN
- Status last verified
- Aug 2022
- First submitted
- 24 Mar 2021
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD will be shared on demand, via Principal Investigator e-mail. There is a prior signed consent of all participants.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Fascia Iliaca Compartment Block on Hip Fracture Patients
- ClinicalTrials.gov ID
- NCT04837924
- Acronym / sponsor ID
- BLOCKPAIN / 0121812
- Conditions
- Hip Fractures
- Keywords
- Hip Fractures, Pain Management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- General Hospital Sveti DuhUniversity, hospital or other
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 26 May 2022 (actual)
- Study completion
- 27 May 2022 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| B (FICB) | Experimental | 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 neededParticipants receiving fascia iliaca compartment block (FICB) |
| A (PLACEBO) | Sham comparator | Drug: paracetamol 1 gram IV, Drug: Rescue analgesic tramadol 100 mg IV if needed, Procedure: Sham injectionParticipants receiving sham injection matching fascia iliaca compartment block (FICB) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (10 listed)
- pathological fracture
- head injury
- body mass bellow 50 kg
- cognitive impairment (Abbreviated Mental Test Score less then 6 points)
- oral anticoagulant drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | B (FICB) |
| paracetamol 1 gram IVparacetamol 1 gram IV every six hours, 4 times in 24 hours | Drug | A (PLACEBO), B (FICB) |
| Rescue analgesic tramadol 100 mg IV if neededRescue analgesic, if needed, tramadol 100 mg in 100 ml saline (0,9% Sodium chloride) IV, up to 4 times in 24 hours | Drug | A (PLACEBO), B (FICB) |
| Sham injectionSting with blunt needle, (without piercing the skin), same site as fascia iliaca compartment block | Procedure or surgery | A (PLACEBO) |
Primary outcome
Stress Response 1
Time frame: Change from baseline cortisol plasma level at 24 hours
cortisol plasma level
Stress Response 2
Time frame: Change from baseline copeptin plasma level at 24 hours
copeptin plasma level
Acute confusional state/Delirium
Time frame: 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
1 secondary outcome
Pain Intensity
Time frame: Immediately prior and 30, 120, 240 minutes and 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Individual participant dataSharing planned: Yes. All IPD will be shared on demand, via Principal Investigator e-mail. There is a prior signed consent of all participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anđela Simić principal investigator
Clinical Hospital "Sveti Duh"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fascia iliaca compartment block, (FICB) (levobupivacaine hydrochloride 0,25% 40 ml), paracetamol 1 gram IV and Rescue analgesic tramadol 100 mg IV if needed in people with Hip Fractures, run by General Hospital Sveti Duh at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress Response 1 (time frame: Change from baseline cortisol plasma level at 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.