Hip FracturesNCT04478552
Analgesic Effect of Fascia Iliaca Compartment Block in Geriatric Patients With Hip Fracture
A study testing Fascia iliaca compartment block in people with Hip Fractures, run by United Christian Hospital at 1 site in Hong Kong.
Trial summary
As population in Hong Kong is aging, incidence of geriatrics hip fractures rises. Operative treatment for selective patients offers pain control, early mobilization and reduction in medical morbidities and mortalities. 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
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2019to 14 Oct 2021
- Phase
- Interventional
- 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
- Age 65 or above
- Patients admitted Orthopaedic and Traumatology ward in United Christian Hospital
- Radiographically confirmed unilateral fracture hip
- Patient requiring pre-operative analgesia
- Mentally competent
- Informed consent signed
Who cannot join
- Age less than 65
- Presence of more than one fracture
- Patient refusal to participating in this study
- Known true allergy or previous anaphylactic reaction to local anaesthetic
- Previous femoral-bypass surgery, or near a graft site.
- Previous surgery over the injection site
Show all 10Show fewer
- Inflammation, infection, or hernia over the injection site
- INR >1.4
- Platelet count <100x 10^9/L
- Patient on heparin / fondaparinux / rivaroxaban / dabigatran / ticlopidine / clopidogrel / prasugrel / cilostazol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial on Analgesic Effect of Pre-operative Fascia Iliaca Compartment Block in Geriatric Patients With Hip Fracture
As population in Hong Kong is aging, incidence of geriatrics hip fractures rises. Operative treatment for selective patients offers pain control, early mobilization and reduction in medical morbidities and mortalities. Research has shown that the pain from hip fracture left untreated may have significant physical and psychological effects on the patient, precipitating delirium, especially in elderly patients with hip fractures, and may delay operative management and may complicate hospital stay. Studies report that the pain management for limb fractures in the elderly is hugely sub-optimal with some suggesting that only 2% receive adequate analgesia. Adequate analgesia before definitive treatment of hip fracture may improve mobilization and cognitive performance. As a part of multi-modal pain management, Fascia iliaca compartment block is being increasingly popular as a simple, safe and effective regional technique for patients with hip fractures and proximal femoral shaft fractures, providing consistent analgesic effect for hip fracture patients, irrespective of the performing doctor's experience. This study aims to provide high level local evidence of the effect and efficacy of the fascia iliaca compartment block in preoperative pain control for patients with hip fracture admitted to Orthopaedic and Traumatology ward in United Christian Hospital.
Read the detailed description
This study is a randomized control, single blinded trial. It tests the hypothesis that fascia iliaca compartment block using local anaesthetic agent for pre-operative analgesia in patients with hip fracture, compared to that using normal saline as control, leads to a better pain control and fewer doses of systemic analgesics required. All patients admitted to United Christian Hospital Orthopaedic and Traumatology ward for hip fracture with radiological diagnosis will be seen by on-call resident. Principal investigator and other investigators will be notified of the admission within 1 working day. Subjects will be recruited according to inclusion and exclusion criteria as mentioned in the below section. Subjects will be recruited only if an informed consent for this study has been signed. Only patients with hip fracture pending emergency operation will be recruited. 2 enclosed envelopes will be prepared, in which one indicates "intervention", and one indicates "control". Subjects will randomly choose any of the envelopes without knowing the intervention/control group assignment. To maintain true randomization, the 2 envelopes will be kept in good condition, preventing identification of the underlying assignment from the outer appearance. Investigators, knowing the group assignment, will then prepare an injection kit set for Fascia iliaca compartment block which includes vials of levobupivacaine, normal saline, syringes, 22G/21G needle, simple dressing set and skin antiseptic solution. For the intervention group, fascia iliaca compartment block with 30ml/40ml 0.25% levobupivacaine, depending on body weight (30ml for body weight less than 50kg, 40ml for body weight more than 50kg), will be performed by investigators under landmark approach. For the control group, same volume of normal saline, instead of levobupivacaine, will injected using the same technique, so that single blinding can be achieved. Subjects' vital signs will be observed for every 10 minutes for 30 minutes after injection.
- Conditions
- Hip Fractures
- Being tested
- Fascia iliaca compartment block, Placebo injection
- Keywords
- hip fracture, orthogeriatrics, fascia iliaca compartment block
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascia iliaca compartment blockProcedure or surgery
It involves injecting local anaesthetic agent (levobupivacaine) into the fascia iliaca compartment of the patient, infiltrating three major nerves that supply the medial, anterior and lateral thigh, namely the femoral and lateral femoral cutaneous nerves. This procedure can be done with anatomical landmark approach or under image guidance.
Placebo injectionProcedure or surgery
same volume of normal saline, instead of levobupivacaine, will injected using the same technique.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Procedure: Fascia iliaca compartment block |
| Control group | Placebo comparator | Not described Receives: Procedure: Placebo injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain in terms of Numeric Rating Scale
Numeric Rating Scale (0-10) whereas 0 is the least pain and 10 is the worst pain
Measured: on admission, just before fascia iliaca compartment block, 1 hour after injection, 12 hour after injection, 24 hour after injection, and 48 hour after injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start1 Jun 2019
- Primary completion14 Sep 2021
- Study completion14 Oct 2021
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wan Tze Kit, United Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478552
- Sponsor's protocol ID
- SPv1
- Status last verified
- May 2023
- First submitted
- 25 Mar 2020
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on Analgesic Effect of Pre-operative Fascia Iliaca Compartment Block in Geriatric Patients With Hip Fracture
- ClinicalTrials.gov ID
- NCT04478552
- Acronym / sponsor ID
- SPv1
- Conditions
- Hip Fractures
- Keywords
- hip fracture, orthogeriatrics, fascia iliaca compartment block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- United Christian HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 14 Sep 2021 (actual)
- Study completion
- 14 Oct 2021 (actual)
- First posted
- 20 Jul 2020 (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.
As population in Hong Kong is aging, incidence of geriatrics hip fractures rises. Operative treatment for selective patients offers pain control, early mobilization and reduction in medical morbidities and mortalities. Research has shown that the pain from hip fracture left untreated may have significant physical and psychological effects on the patient, precipitating delirium, especially in elderly patients with hip fractures, and may delay operative management and may complicate hospital stay. Studies report that the pain management for limb fractures in the elderly is hugely sub-optimal with some suggesting that only 2% receive adequate analgesia. Adequate analgesia before definitive treatment of hip fracture may improve mobilization and cognitive performance. As a part of multi-modal pain management, Fascia iliaca compartment block is being increasingly popular as a simple, safe and effective regional technique for patients with hip fractures and proximal femoral shaft fractures, providing consistent analgesic effect for hip fracture patients, irrespective of the performing doctor's experience. This study aims to provide high level local evidence of the effect and efficacy of the fascia iliaca compartment block in preoperative pain control for patients with hip fracture admitted to Orthopaedic and Traumatology ward in United Christian Hospital.
Detailed description
This study is a randomized control, single blinded trial. It tests the hypothesis that fascia iliaca compartment block using local anaesthetic agent for pre-operative analgesia in patients with hip fracture, compared to that using normal saline as control, leads to a better pain control and fewer doses of systemic analgesics required. All patients admitted to United Christian Hospital Orthopaedic and Traumatology ward for hip fracture with radiological diagnosis will be seen by on-call resident. Principal investigator and other investigators will be notified of the admission within 1 working day. Subjects will be recruited according to inclusion and exclusion criteria as mentioned in the below section. Subjects will be recruited only if an informed consent for this study has been signed. Only patients with hip fracture pending emergency operation will be recruited. 2 enclosed envelopes will be prepared, in which one indicates "intervention", and one indicates "control". Subjects will randomly choose any of the envelopes without knowing the intervention/control group assignment. To maintain true randomization, the 2 envelopes will be kept in good condition, preventing identification of the underlying assignment from the outer appearance. Investigators, knowing the group assignment, will then prepare an injection kit set for Fascia iliaca compartment block which includes vials of levobupivacaine, normal saline, syringes, 22G/21G needle, simple dressing set and skin antiseptic solution. For the intervention group, fascia iliaca compartment block with 30ml/40ml 0.25% levobupivacaine, depending on body weight (30ml for body weight less than 50kg, 40ml for body weight more than 50kg), will be performed by investigators under landmark approach. For the control group, same volume of normal saline, instead of levobupivacaine, will injected using the same technique, so that single blinding can be achieved. Subjects' vital signs will be observed for every 10 minutes for 30 minutes after injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Fascia iliaca compartment block |
| Control group | Placebo comparator | Procedure: Placebo injection |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age 65 or above
- Patients admitted Orthopaedic and Traumatology ward in United Christian Hospital
- Radiographically confirmed unilateral fracture hip
- Patient requiring pre-operative analgesia
- Mentally competent
Key exclusion criteria (10 listed)
- Age less than 65
- Presence of more than one fracture
- Patient refusal to participating in this study
- Known true allergy or previous anaphylactic reaction to local anaesthetic
- Previous femoral-bypass surgery, or near a graft site.
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 blockIt involves injecting local anaesthetic agent (levobupivacaine) into the fascia iliaca compartment of the patient, infiltrating three major nerves that supply the medial, anterior and lateral thigh, namely the femoral and lateral femoral cutaneous nerves. This procedure can be done with anatomical landmark approach or under image guidance. | Procedure or surgery | Intervention group |
| Placebo injectionsame volume of normal saline, instead of levobupivacaine, will injected using the same technique. | Procedure or surgery | Control group |
Primary outcome
Change in pain in terms of Numeric Rating Scale
Time frame: on admission, just before fascia iliaca compartment block, 1 hour after injection, 12 hour after injection, 24 hour after injection, and 48 hour after injection.
Numeric Rating Scale (0-10) whereas 0 is the least pain and 10 is the worst pain
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 23 May 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fascia iliaca compartment block in people with Hip Fractures, run by United Christian Hospital at 1 site in Hong Kong.
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 6 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 23 May 2023. 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 Hong Kong. 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.
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?
Change in pain in terms of Numeric Rating Scale (time frame: on admission, just before fascia iliaca compartment block, 1 hour after injection, 12 hour after injection, 24 hour after injection, and 48 hour after injection.). 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 23 May 2023.