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| ID | Type | Description | Link |
|---|---|---|---|
| AG030141-01 A1 | Other Grant/Funding Number | National Institute on Aging (NIA) |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The purpose of this study is to compare two different methods of treating pain after a hip fracture.
This project examines the efficacy and effects of 2 regional anesthesia techniques, femoral nerve blocks (FNB) and fascia iliaca blocks (FIB), on the treatment of peri-operative acute hip (femoral neck, intertrochanteric) fracture pain. Patients age 60 years and over presenting to two New York City emergency departments with hip fracture will be randomized to receive the intervention or usual care. The intervention includes single injection FNB in the ED followed by insertion of a continuous FIB catheter within 24 hours of the single injection FNB plus "as needed" non-opioid/opioid analgesia. Usual care patients will receive conventional therapy with regularly scheduled intravenous or oral opioids plus "as needed" non/opioids/opioids. We will examine the impact of the intervention on patients' self reported pain intensity; systemic opioid requirements; post-operative function; incidence of delirium, treatment related side effects; and hospital length of stay and participation in physical therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Femoral Nerve Block | Experimental | Intervention patients will have a continuous fascia iliaca blocks placed by a regional anesthesiologist 24 hours after the initial single injection femoral nerve block or at the time of surgery. |
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| No Intervention | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Femoral Nerve Block | Procedure | Patients assigned to the intervention group will have a femoral nerve block administered by the attending emergency department physician. Twenty-four hours after the femoral nerve block or at the time of surgery, an anesthesiologist will insert a continuous fascia iliaca block. Both procedures (femoral nerve block and fascia iliaca blocks) are standard anesthetic techniques that are used in orthopedic procedures but their efficacy as compared to standard opioid therapy has not been evaluated in controlled clinical trials in hip fracture. The medications that will be used in each procedure are as follows: 1) femoral nerve block: 0.5% bupivacaine with 1:300,000 epinephrine; 2) fascia iliaca block: 0.2% ropivacaine will be infused at 5ml/hr. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain; 11-point Numeric Rating Scale | three times daily for pain for the duration of hospital stay (average stay is 4 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Delirium; Confusion Assessment Method (CAM). | three times daily for pain for the duration of hospital stay (average stay is 4 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| R. Sean Morrison, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Knox Todd, MD, MPH | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel | New York | New York | 10003 | United States | ||
| Icahn School of Medicine at Mount Sinai |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33238043 | Derived | Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3. |
| Label | URL |
|---|---|
| National Palliative Care Research Center | View source |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D006620 | Hip Fractures |
| D005264 | Femoral Fractures |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050723 | Fractures, Bone |
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|
| New York |
| New York |
| 10029 |
| United States |
| Maimonides Medical Center | New York | New York | 11219 | United States |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |