Clinical trial NCT00749489: Improving Pain and Function in Hip Fracture
Official title: Improving Pain and Function in Hip Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Hip Fractures
Keywords: Pain
Hip Fractures
Femoral Fractures
Analgesics
Opioid
Nerve Block
Geriatric
Nerve Stimulation
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2008-09-09
Enrollment: 164
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two different methods of treating pain after a hip fracture.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* All adult patients 60 years of age and over that present to the MSMC ED from 8:00 to 20:00 with a radiographically confirmed hip fracture (femoral neck, intertrochanteric, or peri-capsular) will be screened for study eligibility.

Exclusion Criteria:

* History of advanced dementia
* Presence of multiple trauma, pathological fractures, bilateral hip fractures, or previous fracture or surgery at the currently fractured site
* Patients transferred from another hospital
* Patients with cirrhosis or liver failure.
* The investigators exclude patients with advanced dementia because the investigators will require patients to self-report their pain intensity.
* The investigators exclude these categories of hip fracture because they represent patients with atypical or often problematic clinical circumstances.
* The investigators exclude patients under age 60 because our focus is on treatment of pain in older adults. Younger adults (less than age 60) typically present with fractures of different cause (severe and multiple trauma), are less sensitive to the side effects and complications of opioid therapy, are less likely to have delayed or prolonged functional recovery, and are less sensitive to the adverse and sometimes permanent effects of prolonged bed rest (i.e., from pain) on function.
* The investigators exclude patients with hepatic dysfunction because the intervention protocol includes administration of acetaminophen which can provoke liver failure in patients with advanced liver disease.

Primary outcomes:
measure: Pain; 11-point Numeric Rating Scale
timeFrame: three times daily for pain for the duration of hospital stay (average stay is 4 days)
Secondary outcomes:
measure: Delirium; Confusion Assessment Method (CAM).
timeFrame: three times daily for pain for the duration of hospital stay (average stay is 4 days)
Other outcomes:
Locations:
city: New York
country: United States
facility: Beth Israel
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Maimonides Medical Center
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: R. Sean Morrison, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: M.D. Anderson Cancer Center
name: Knox Todd, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.