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Improving Pain and Function in Hip Fracture

Primary Purpose

Pain, Hip Fractures

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Femoral Nerve Block

About this trial

This is an interventional treatment trial for Pain focused on measuring Pain, Hip Fractures, Femoral Fractures, Analgesics, Opioid, Nerve Block, Geriatric, Nerve Stimulation

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Beth Israel
Icahn School of Medicine at Mount Sinai
Maimonides Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Femoral Nerve Block

No Intervention

Arm Description

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.

No intervention

Outcomes

Primary Outcome Measures

Pain; 11-point Numeric Rating Scale

Secondary Outcome Measures

Delirium; Confusion Assessment Method (CAM).

Full Information

NCT ID

NCT00749489

First Posted

September 8, 2008

Last Updated

June 24, 2014

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT00749489

Brief Title

Improving Pain and Function in Hip Fracture

Official Title

Improving Pain and Function in Hip Fracture

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Hip Fractures

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

164 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Femoral Nerve Block

Arm Type

Experimental

Arm Description

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.

Arm Title

No Intervention

Arm Type

No Intervention

Arm Description

No intervention

Intervention Type

Procedure

Intervention Name(s)

Femoral Nerve Block

Intervention Description

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.

Primary Outcome Measure Information:

Title

Pain; 11-point Numeric Rating Scale

Time Frame

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

Secondary Outcome Measure Information:

Title

Delirium; Confusion Assessment Method (CAM).

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

R. Sean Morrison, MD

Organizational Affiliation

Icahn School of Medicine at Mount Sinai

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Knox Todd, MD, MPH

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beth Israel

City

New York

State/Province

New York

ZIP/Postal Code

10003

Country

United States

Facility Name

Icahn School of Medicine at Mount Sinai

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Maimonides Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

11219

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

33238043

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.

Results Reference

derived

Links:

URL

http://www.npcrc.org

Description

National Palliative Care Research Center

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Improving Pain and Function in Hip Fracture

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