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Continuous Fascia Iliaca Block for Acute Hip Fractures

Primary Purpose

Hip Fractures, Neuromuscular Blockade, Respiratory Morbidity

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Continuous fascia iliaca block
Ropivacaine
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures focused on measuring hip fracture, fascia iliaca block, continuous fascia iliaca block, neuromuscular blockade

Eligibility Criteria

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

Inclusion Criteria:

  • Adults age greater than or equal to 65 years old with acute hip fracture

Exclusion Criteria:

  • ASA greater than or equal to 4
  • Open fractures
  • Other concomitant injuries that may interfere with positioning or pain scores
  • Local anesthetic allergy
  • Delirium at the time of consent
  • Pre-existing cognitive impairment
  • Infection at the site of injection for cFIB
  • Previous surgery in femoral triangle
  • Warfarin or Anti-Xa inhibitor use
  • Long-term opioid use
  • Intraoperative complications

Sites / Locations

  • Royal University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Treatment

Continuous fascia iliaca block

Arm Description

Patients in this group will receive standard treatment orders which include a combination of opioids, NSAIDs, acetaminophen, and other adjuncts for analgesia.

The cFIB group will receive an ultrasound guided cFIB and standard treatment orders as backup in the event of block failure. The cFIB group will receive an initial bolus of 40 cc of 0.25% Ropivacaine followed by an infusion of 8 cc/hr until the time of surgery. Immediately pre-operatively, the anesthesiologist performing the case will bolus the catheter 40 cc of 0.25% ropivacaine and discontinue the catheter.

Outcomes

Primary Outcome Measures

Respiratory complications
Use of supplemental oxygen, need for positive pressure ventilation, decreased oxygen saturations, radiographic evidence of atelectasis or pneumonia

Secondary Outcome Measures

Pain score
Subjective pain score on 1-10 visual analog scale in supine, semi-recumbent, upright positions, and with active movement
Opioid side effects
Incidence of nausea, vomiting, pruritus, constipation, and urinary retention will be recorded
30 day mortality
Status, living or deceased, at 30 days post op
Delirium
CAM-ICU scoring system will be used daily to measure delirium
Post op length of stay
Will be measured as number of days in hospital from date of admission until ready for discharge

Full Information

First Posted
April 27, 2018
Last Updated
May 19, 2019
Sponsor
University of Saskatchewan
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1. Study Identification

Unique Protocol Identification Number
NCT03588689
Brief Title
Continuous Fascia Iliaca Block for Acute Hip Fractures
Official Title
Continuous Fascia Iliaca Block for Acute Hip Fractures: a Randomized Controlled Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
May 7, 2018 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Hip fractures are a major cause of morbidity and mortality in the elderly with over 30,000 hip fractures occuring in Canada annually and over 1300 in Saskatchewan. The estimated cost associated with hip fractures is over $600 million nationally and 28 million dollars in Saskatchewan. Hip fractures cause a great deal of pain and immobility and are mainly treated with surgical fixation. In the perioperative period, hip fracture patients are treated mainly with opioids and other adjuncts such as NSAIDS and acetaminophen. Opioid consumption in the elderly population can predispose to delirium and respiratory complications such as atelectasis, respiratory depression, and pneumonia. Fascia iliaca blocks have been shown to be an effective mode of analgesia for patients with hip fractures, but are underutilized for varying reasons including culture of practice, expertise with performing the block, and having a dedicated service to do so. This study aims to compare the efficacy of fascia iliaca blocks to standard treatment (opioids) in the management of pain in hip fracture patients with a particular focus on outcomes such as the incidence of delirium, respiratory complications, and length of stay in hospital. Our idea is that if we can reduce the amount of opioids these patients receive then they will have improved pain control, fewer respiratory complications, earlier time to mobilizing, and shorter hospital stays. As far as we are aware this relation has not been well studied.
Detailed Description
This study is a prospective randomized controlled non-blinded pilot study. Recruitment and Randomization: fifty adult patients with hip fractures for surgical fixation presenting to Royal University Hospital (RUH), Saskatoon, Saskatchewan, will be recruited. The exclusion criteria are: American Society of Anesthesiologists (ASA) score >3 Other injuries that interfere with block positioning and assessment of pain Local anesthetic allergy Open fracture Moderate to severe pre-operative delirium (interfering with consent and assessment) Sepsis at site of injection Anticoagulation with warfarin or anti-Xa inhibitors Age less than 65 years Patients will be randomized into one of two research arms: Continuous Fascia Iliaca block (cFIB) vs standard treatment (opioids). It is important to note here is that patients receiving cFIBs will have standard treatment orders available in the event of block failure, and opioid consumption will be monitored. Methods: Patients with hip fractures presenting to RUH will be approached by a member of the study team for consent to participate in the study. After consent is obtained patients will be randomised to either arm of the study group. The cFIB group will receive an ultrasound guided cFIB and standard treatment orders as backup in the event of block failure. The standard treatment group will receive only standard treatment orders which include a combination of opioids, NSAIDS, acetaminophen, and other adjuncts for analgesia. The CFIB group will receive an initial bolus of 40 cc of 0.125% Ropivacaine followed by an infusion of 10 cc/hr of 0.2% ropivacaine until the time of surgery. Immediately pre-operatively, the anesthesiologist performing the case will bolus the catheter with 40 cc of 0.125% ropivacaine and discontinue the catheter. Data collection: Demographic and epidemiologic data will be collected for both groups at the time of recruitment. Patients will be followed from the time of enrollment until the time of discharge from hospital. A member of the study team will visit daily and assess the patients for delirium using the Confusion Assessment Method (CAM)-ICU tool, which is a validated delirium assessment tool. Pain scores will be obtained after block insertion and twice a day until surgical fixation takes place. Pain scores will be assessed in the supine, semi recumbent, and upright position, and with active movement. Opioid consumption will be recorded as morphine equivalents for the entire length of hospital stay. The incidence of side effects of opioids will be recorded including : Nausea, vomiting, pruritis, constipation, and urinary retention. The length of time from surgery until ready to discharge will be recorded. It is difficult to directly measure respiratory complications. As a surrogate for respiratory complications the following data will be collected: Oxygen requirements pre and post operatively Pre and post operative need for positive pressure ventilation (CPAP, BiPAP) Radiographic evidence of atelectasis or pneumonia Trends in oxygen saturation as measured by pulse oximetry Data collection is projected to be completed by July 1st 2018 Data analysis: Parametric data will be reported as a mean +/- standard deviation, along with confidence intervals. Means will be used to estimate effect size and these values will then be used in power calculations and sample size estimation for future studies. In addition, the unpaired t-test will be used to test for significant difference between groups. The incidence of adverse events will be recorded and presented with descriptive statistics. Data analysis is projected to be completed by October 2018 Significance: Fascia Iliaca blocks have already been shown to improve pain in hip fracture patents. Our theory is that if we can effectively manage pain with cFIBs we can reduce the amount of opioids patients receive in the perioperative period. This could lead to reduced complications from opioids, improved patient positioning, improved patient mobility, and earlier time to discharge which would have a great impact on patient experience and cost of care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Neuromuscular Blockade, Respiratory Morbidity, Delirium, Fascia Iliaca Block, Pain
Keywords
hip fracture, fascia iliaca block, continuous fascia iliaca block, neuromuscular blockade

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
This study is a prospective randomized controlled non-blinded pilot study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Treatment
Arm Type
No Intervention
Arm Description
Patients in this group will receive standard treatment orders which include a combination of opioids, NSAIDs, acetaminophen, and other adjuncts for analgesia.
Arm Title
Continuous fascia iliaca block
Arm Type
Experimental
Arm Description
The cFIB group will receive an ultrasound guided cFIB and standard treatment orders as backup in the event of block failure. The cFIB group will receive an initial bolus of 40 cc of 0.25% Ropivacaine followed by an infusion of 8 cc/hr until the time of surgery. Immediately pre-operatively, the anesthesiologist performing the case will bolus the catheter 40 cc of 0.25% ropivacaine and discontinue the catheter.
Intervention Type
Procedure
Intervention Name(s)
Continuous fascia iliaca block
Intervention Description
Regional nerve block performed under ultrasound guidance. A catheter will be left in place to allow ongoing infusion of local anesthetic.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Ropivacaine local anesthetic will be used for the fascia iliaca block
Primary Outcome Measure Information:
Title
Respiratory complications
Description
Use of supplemental oxygen, need for positive pressure ventilation, decreased oxygen saturations, radiographic evidence of atelectasis or pneumonia
Time Frame
During hospital stay, up to 1 month
Secondary Outcome Measure Information:
Title
Pain score
Description
Subjective pain score on 1-10 visual analog scale in supine, semi-recumbent, upright positions, and with active movement
Time Frame
During hospital stay, up to 1 month
Title
Opioid side effects
Description
Incidence of nausea, vomiting, pruritus, constipation, and urinary retention will be recorded
Time Frame
During hospital stay, up to 1 month
Title
30 day mortality
Description
Status, living or deceased, at 30 days post op
Time Frame
Will be collected from hospital record, at up to 3 months after enrolment.
Title
Delirium
Description
CAM-ICU scoring system will be used daily to measure delirium
Time Frame
During hospital stay, up to 1 month
Title
Post op length of stay
Description
Will be measured as number of days in hospital from date of admission until ready for discharge
Time Frame
During hospital stay, up to 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults age greater than or equal to 65 years old with acute hip fracture Exclusion Criteria: ASA greater than or equal to 4 Open fractures Other concomitant injuries that may interfere with positioning or pain scores Local anesthetic allergy Delirium at the time of consent Pre-existing cognitive impairment Infection at the site of injection for cFIB Previous surgery in femoral triangle Warfarin or Anti-Xa inhibitor use Long-term opioid use Intraoperative complications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Brownbridge, MD
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Churao Yang, MD
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We will not be sharing individual participant data.
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

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Continuous Fascia Iliaca Block for Acute Hip Fractures

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