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The goal of this study is to compare the analgesic effect of a blind fascia iliaca compartment block to an ultrasound-guided femoral nerve block in patients that present to the emergency department with hip fractures.
Hip fractures often present to the emergency department and elderly, already fragile, patients are overrepresented. The pain associated with a hip fracture can be severe and have deleterious effects on the patient. Many studies, and a Cochrane review, have shown that a peripheral nerve block provides good pain relief and has many benefits compared to traditional pain relief, such as intravenous morphine. There is less consensus regarding which kind of nerve block, and which technique, is best to use. Many studies compared different kinds of nerve blocks to traditional methods, or more recently compared different kinds of ultrasound-guided techniques to each other.
This study proposes to compare the widely used technique of a blind fascia iliaca compartment block (FICB) to an ultrasound-guided femoral nerve block (FNB) that is currently being rolled out locally as an alternative. During the implementation period of this new clinical routine, it will be possible to compare the efficacy of FICB and FNB in reducing participant-reported pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fascia Iliaca Compartment Block (FICB) | Participants with a radiologically verified hip fracture receiving a FICB using a blind technique guided by anatomical landmarks. |
| |
| Femoral Nerve Block (FNB) | Participants with a radiologically verified hip fracture receiving a FNB using ultrasound guidance for direct nerve visualisation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fascia Iliaca Compartment Block | Procedure | Blind technique. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change from Baseline in Pain Scores on the Numeric Rating Scale (0 to 10, where 10 is Maximum Pain) at 30 minutes after Administration of Block, at Rest and During Active Hip Flexion | Change in reported pain score should be at least one whole unit on the numeric rating scale. | Measured 30 minutes after administered nerve block. |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of Failed Blocks | Defined by a failure to reduce reported pain 30 minutes after administered block by at least one whole unit on the numeric rating scale | Through study completion, an average of 1 year |
| Rate of Complications |
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Inclusion Criteria:
Exclusion Criteria:
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All adult patients in the emergency department with a radiologically verified hip fracture eligible for a peripheral nerve block according to local guidelines
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Leckström, MBBS | Contact | +46704555507 | daniel.leckstrom@regionostergotland.se | |
| Sofia Freland, PhD, MD | Contact | +46705868671 | sofia.freland@regionostergotland.se |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Wilhelms, PhD, MD | University Hospital, Linköping | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akutmottagningen US Östergötland | Recruiting | Linköping | Östergötland County | 58185 | Sweden |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 26, 2022 | Apr 26, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000077212 | Ropivacaine |
| D000779 | Anesthetics, Local |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D000813 | Anilides |
| D000577 | Amides |
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| Femoral Nerve Block | Procedure | Ultrasound guided. |
|
|
| Ropivacaine | Drug | Ropivacaine dosed according to local guidelines. |
|
|
Comparing the rate of any reported complication between cohorts
| Through study completion, an average of 1 year |
| D007869 |
| Leg Injuries |
| D009930 |
| Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |