Postop Pain Control in Hip Fracture Surgery: Fascia Iliaca Compartment Block Versus Fracture Block

July 12, 2023 updated by: Montefiore Medical Center

Postoperative Pain Control in Extracapsular Hip Fracture Patients: Fascia Iliaca Compartment Block Versus Fracture Block

The investigators propose to investigate the effect of intraoperative FICB and intrafragmentary fracture blockade on postoperative pain and opiate consumption using a randomized controlled trial study design. There will be three treatment groups: (1) fascia iliaca compartment blockade administered after surgical fixation using the loss of resistance technique with 30cc 0.25% marcaine (2) intrafragmentary fracture block using fluoroscopy guidance after surgical fixation with 30cc 0.25% marcaine and (3) placebo group, with no intervention.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The incidence of fragility hip fractures in elderly patients is increasing steadily in the United States and worldwide, and the mortality, morbidity and economic impact of this injury is staggering. The injury itself can result in severe pain, both preoperatively and throughout the perioperative course. These patients are also at increased risk for delirium. They are by definition elderly, and often have multiple comorbidities in addition to underlying cognitive dysfunction. Current studies estimate that the incidence of delirium after a hip fracture approaches 30%, and there is a well-established though not completely understood interaction between opioid use in elderly patients and delirium. Pain and delirium are not only poor outcomes in themselves, but they can also interfere with the rehabilitation necessary for a successful outcome after hip fracture surgery. For this reason, the topic of multimodal pain management in hip fracture patients has gained considerable traction.

One popular "opioid-sparing" strategy in these patients is regional pain blockades, administered by an anesthesia block team or by emergency room physicians. Due to the neuroanatomy of the hip region, which has sensory innervations from the sciatic, femoral, and obturator nerve, with lesser contributions from the nerve to quadratus femoris and superior gluteal nerve, effective regional blockade of the hip joint with existing methods can be a challenge. One commonly employed and researched block is the fascia iliaca compartment block (FICB), a regional block administered under ultrasound guidance or anatomical landmarks that targets the femoral nerve, the lateral femoral cutaneous nerve, and to a lesser extent, the obturator nerve. Various studies of FICB and the closely related femoral nerve block have demonstrated benefits in pain control, ease of positioning, and reduction in opiate use, and systematic reviews have concluded that the fascia iliaca compartment block is a useful and safe method to enhance preoperative pain control in hip fracture patients. However, prior research has focused on the preoperative period, with blocks placed by an anesthesia team or emergency room physicians shortly after presentation and diagnosis of a hip fracture. Additionally, no distinction is made between intracapsular or extracapsular hip fractures, except in scattered post-hoc analyses. Our project aims to investigate the efficacy of a FICB administered intraoperatively by the operating surgeon on extracapsular hip fracture patients. In addition, the investigators propose investigating intrafragmentary blockade at the fracture site itself. Fracture hematoma blocks are used extensively in orthopedics, and have demonstrated pain control equivalent to conscious sedation for the manipulation of ankle and distal radius fractures.

Study Design

The investigators propose to investigate the effect of intraoperative FICB and intrafragmentary fracture blockade on postoperative pain and opiate consumption using a randomized controlled trial study design. There will be three treatment groups: (1) fascia iliaca compartment blockade administered after surgical fixation using the loss of resistance technique with 30cc 0.25% marcaine (2) intrafragmentary fracture block using fluoroscopy guidance after surgical fixation with 30cc 0.25% marcaine and (3) placebo group, with no intervention

Randomization will occur at time of enrollment using unmarked envelopes. After consent, patients will be assigned a study ID that will be transcribed on the opaque envelope. The envelope will be unsealed in the operating room at time of surgery to determine the planned intervention, and it's contents will not be made available to the study personnel gathering postoperative pain data. The envelopes and randomization assignments will be kept in a locked, secured location. The only study personnel who will be unblinded are the operating surgeon and residents and physican assistants assisting in the operating room. Study personnel who participate in the case will not collect postoperative pain data.

The investigators will monitor various safety outcomes, including perioperative cardiac or respiratory events, mortality, and escalation of care (i.e. SICU transfer). Each adverse event will be analyzed by the senior operating surgeons to determine if the study intervention could have had a role in the event.

Our outcome measurements are pain visual analogue scores and narcotic use postoperatively. Calculations of narcotic use will be standardized to IV morphine equivalents. The associated primary and secondary hypotheses are as follows:

  • Primary: There is a statistically significant difference in pain visual analogue scale (VAS) between extracapsular hip fracture patients treated intraoperatively with fascia iliaca block, fracture block, or conventional analgesia in the first 24 hours postoperatively.
  • Secondary: There is a statistically significant difference in opioid consumption (measured in IV morphine equivalents / time) between extracapsular hip fracture patients treated intraoperatively with fascia iliaca block, fracture block, or conventional analgesia in the first 24 hours postoperatively.

Study Population

Our study population will be focused on elderly patients with low energy extracapsular (intertrochonteric, subtrochanteric) hip fractures. Inclusion criteria will include age 60 years or older, low energy mechanism (i.e. mechanical or syncopal fall from ground level), and extracapsular location as defined on AP and lateral radiographs of the hip. Exclusion criteria includes polytrauma patients with multiple injuries, high energy mechanisms (i.e. pedestrian struck, motor vehicle collision, fall from height), inability for the patient to consent for themselves, pathologic fracture types (secondary to tumor or atypical fractures due to bisphosphonate use), and intolerance or allergies to opioids or local anethestics.

Sample size projections target a sample of 105 patients, 35 in each group. This is based on calculation of 80% power to detect a 10mm difference in the VAS score using means and standard deviations from previous publications with measurements of pain scores in hip fracture patients. Since the duration of followup is limited to the immediate postoperative period, the investigators do not anticipate a significant drop out or loss-to-follow up rate.

Recruitment

Recruitment will occur in the emergency department by study personnel. After diagnosis of an extracapsular hip fracture is made, the exclusion and inclusion criteria will be reviewed, and eligible patients will be approached for voluntary participation in the research study.

Informed Consent

Study personnel will obtain consent in the emergency room or shortly after admission to the floor. Please find attached the planned consent form.

Risks

The proposed intervention, marcaine for regional blockade, has been studied extensively, and has been demonstrated to be safe. The risk of intravascular introduction of lidocaine is possible, but exceedingly rare. Per standarad procedure, the investigators will plan to aspirate the syringe before injection to confirm extravascular targeting. Another known risk of regional blockade is muscle weakness in the immediate postoperative period due to blockade of motor nerves. If not appropriately managed, this could create a risk of falling. Patients are routinely assessed by physical therapy for strength and muscle control before attempting ambulation postoperatively, and this will continue to be the practice. Furthermore, postoperative hip fracture patients, if they do ambulate post operative day 0, are closely assisted by physical therapists, reducing the risk of fall.

Data Analysis

Differences between study groups in regards to their baseline characteristics and outcomes will be assessed using two-sided Fisher's exact tests, chi-square tests for categorical variables, and independent samples student T-tests for continuous variables. The investigators will plan to undertake a multivariable analyses as well.

Data Quality and Management

The investigators plan to use a REDCap database for data collection and monitoring. Patient specific data will be entered by study personnel into the REDCap database after completion of the patient's intervention and postoperative followup. This will avoid disrupting the blinding of study personnel gathering postoperative pain data. Postoperative narcotic use will be gathered from a chart review of ordered and administered medications.

Study Type

Interventional

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10461
        • Jacobi Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age 60 years or older
  • low energy mechanism (i.e. mechanical or syncopal fall from ground level)
  • extracapsular location as defined on AP and lateral radiographs of the hip

Exclusion Criteria:

  • polytrauma patients with multiple injuries, high energy mechanisms (i.e. pedestrian struck, motor vehicle collision, fall from height)
  • inability for the patient to consent for themselves
  • pathologic fracture types (secondary to tumor or atypical fractures due to bisphosphonate use)
  • intolerance or allergies to opioids or local anesthetics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo group, with no regional nerve blockade administered.
Procedure: Cephalomedullary nailing of extracapsular hip fracture
All patients will undergo cephalomedullary nailing of their extracapsular hip fractures. Both short and long nails will be used based on fracture morphology.
Device: cephalomedullary nail
Implants to be used will be variable, but include Stryker Gamma, Synthes Trochanteric Fixation Nail, Smith and Nephew Intertan.
Experimental: Fracture block
Patients will have an intrafragmentary fracture block using fluoroscopy guidance after surgical fixation with 30cc 0.25% marcaine
Procedure: Cephalomedullary nailing of extracapsular hip fracture
All patients will undergo cephalomedullary nailing of their extracapsular hip fractures. Both short and long nails will be used based on fracture morphology.
Device: cephalomedullary nail
Implants to be used will be variable, but include Stryker Gamma, Synthes Trochanteric Fixation Nail, Smith and Nephew Intertan.
Drug: Regional Anesthetics
Marcaine 0.25% will be administered for the two experimental arms, as described in above protocol.
Other Names:
  • Local anesthetics
Experimental: Fascia iliaca block
Fascia iliaca compartment blockade administered after surgical fixation using the loss of resistance technique with 30cc 0.25% marcaine
Procedure: Cephalomedullary nailing of extracapsular hip fracture
All patients will undergo cephalomedullary nailing of their extracapsular hip fractures. Both short and long nails will be used based on fracture morphology.
Device: cephalomedullary nail
Implants to be used will be variable, but include Stryker Gamma, Synthes Trochanteric Fixation Nail, Smith and Nephew Intertan.
Drug: Regional Anesthetics
Marcaine 0.25% will be administered for the two experimental arms, as described in above protocol.
Other Names:
  • Local anesthetics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain visual analog scores
Time Frame: 24 hours
The pain visual analog scale will be used to record pain scores from 0 (no pain) to 10 (worst pain imaginable).
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid usage
Time Frame: 24 hours
The amount of opioid pain medications used in the 24-hour postoperative period will be converted to morphine equivalents as published by the Center for Medicare and Medicaid Services and summed.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Collaborators

Jacobi Medical Center

Investigators

  • Principal Investigator: Milan Sen, Jacobi Medical Center; Albert Einstein College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2021

Primary Completion (Actual)

March 17, 2023

Study Completion (Actual)

March 17, 2023

Study Registration Dates

First Submitted

April 3, 2020

First Submitted That Met QC Criteria

April 3, 2020

First Posted (Actual)

April 6, 2020

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-10737

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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