Improving Pain and Function in Hip Fracture

NCT00749489 | Completed Phase 3 DMC

• 2 other identifiers: GCO 06-0721AG030141-01 A1
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Pain; Hip Fractures

Keywords

Pain; Hip Fractures; Femoral Fractures; Analgesics; Opioid; Nerve Block; Geriatric; Nerve Stimulation

Outcome Measures

Primary Outcomes (1)

• Pain; 11-point Numeric Rating Scale

  three times daily for pain for the duration of hospital stay (average stay is 4 days)

Secondary Outcomes (1)

• Delirium; Confusion Assessment Method (CAM).

  three times daily for pain for the duration of hospital stay (average stay is 4 days)

Study Arms (2)

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.

Procedure: Femoral Nerve Block

No Intervention

NO INTERVENTION

No intervention

Interventions

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.

Femoral Nerve Block

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute on Aging (NIA): collaborator

Study Sites (3)

Beth Israel

New York, New York, 10003, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Maimonides Medical Center

New York, New York, 11219, United States

Location

Related Publications (1)

• 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.

  PMID: 33238043 DERIVED

Related Links

• National Palliative Care Research Center

MeSH Terms

Conditions

Pain; Hip Fractures; Femoral Fractures

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• R. Sean Morrison, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Knox Todd, MD, MPH

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2008
• First Posted: September 9, 2008
• Study Start: November 1, 2008
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 25, 2014

Record last verified: 2014-06

Locations

US (3)