Continuous Fascia Iliaca Block for Acute Hip Fractures

NCT03588689 | Completed Phase 4

• 1 other identifier: Bio 17-267
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Fractures; Neuromuscular Blockade; Respiratory Morbidity; Delirium; Fascia Iliaca Block; Pain

Keywords

hip fracture; fascia iliaca block; continuous fascia iliaca block; neuromuscular blockade

Outcome Measures

Primary Outcomes (1)

• Respiratory complications

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

  During hospital stay, up to 1 month

Secondary Outcomes (5)

• Pain score

  During hospital stay, up to 1 month

• Opioid side effects

  During hospital stay, up to 1 month

• 30 day mortality

  Will be collected from hospital record, at up to 3 months after enrolment.

• Delirium

  During hospital stay, up to 1 month

• Post op length of stay

  During hospital stay, up to 1 month

Study Arms (2)

Standard Treatment

NO INTERVENTION

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

Continuous fascia iliaca block

EXPERIMENTAL

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.

Procedure: Continuous fascia iliaca block; Drug: Ropivacaine

Interventions

Continuous fascia iliaca block PROCEDURE

Regional nerve block performed under ultrasound guidance. A catheter will be left in place to allow ongoing infusion of local anesthetic.

Continuous fascia iliaca block

Ropivacaine DRUG

Ropivacaine local anesthetic will be used for the fascia iliaca block

Continuous fascia iliaca block

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

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

MeSH Terms

Conditions

Hip Fractures; Delirium; Pain

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Brian Brownbridge, MD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

• Churao Yang, MD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Model Details: This study is a prospective randomized controlled non-blinded pilot study.

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: July 17, 2018
• Study Start: May 7, 2018
• Primary Completion: March 31, 2019
• Study Completion: May 1, 2019
• Last Updated: May 21, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)