Recruiting

Analgesia

Sponsor:

University Health Network, Toronto

Code:

NCT03609645

Conditions

Hip Fractures

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Fascia iliaca block

Femoral articular branches block(FAB)

Study Details

Brief summary:

Hip Fracture is a common orthopedic emergency in elderly people, which causes moderate to severe pain. Until now, different methods of pain treatment have been used, including pain-killer medication, which given in to the vein, and a nerve block.. A nerve block is the defined as injection of a freezing/numbing medication (local anesthetic) around the nerve area in order to stop pain.

Painkiller medications by themselves are not enough to stop pain, especially the pain that start with movement.

At the Toronto Western hospital, patients with hip fracture will generally receive a fascia iliac block (FIB) within 24 hours of hospital admission as a standard of care.

Fascia iliaca block is a nerve block done by injecting local anestheticat the level of the groin. This done to provide pain relief and is done either in the emergency room or in the inpatient area.

Studies have shown that nerves supplying other areas in the hip may be blocked to relive hip pain fracture.

Additional to this method, there is a newer type of nerve block, called the femoral articular branch block (FAB) that aim to block the nerves supplying the hip joint.

This new block has been described based on better understanding of the anatomy of the nerves that control hip pain. This block consists on an injection in the groin at a similar location as the Fascia iliaca block except that the needle has to go slightly deeper (by a few centimeters) to reach a better target.

Based on the current understanding on anatomy it is possible that this new technique may provide better pain control than a Fascia Iliaca Block.

The purpose of the study is to investigate the degree of pain relief achieved by the two different nerve block techniques: 1) Fascia iliaca block (FIB) and 2) Femoral and AON articular branches block (FAB).

Conditions

Hip Fractures

Study ID

NCT03609645

Start date

Feb 19, 2019

Status verified date

Jul, 2018

Completion date

Jan, 2020

Anticipated

Primary completion date

Sep, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ASA Physical Status I-III
  • 60 years old or older
  • BMI 18-40
  • Scheduled for hip fracture surgical fixation

Exclusion Criteria:

  • Bilateral hip fracture
  • Lack of mental ability to provide informed consent
  • Pre-existing neuropathic pain or sensory disorders of the surgical limb
  • Contraindication to regional anesthesia (Intolerance to the study drugs, bleeding diathesis, coagulopathy, malignancy or infection at the site of the block)
  • Chronic opioid use defined as >30 mg of daily oral morphine equivalents

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Fascia iliaca block (FIB)

Group will receive Fascia iliaca block (FIB) with local anesthetic and femoral articular branch block (FAB) with normal saline (Placebo).

experimental: Femoral articular branches block(FAB)

Group will receive Fascia iliaca block (FIB) with normal saline (Placebo) and Femoral AON articular branch block (FAB) with local anesthetic.

Interventions

Fascia iliaca block

FIB Placebo Block: 20mL of Normal Saline Active drug: 20mL of 0.25% Bupivacaine with epinephrine (1:400, 000)

FAB block Placebo Block: 20mL of Normal Saline Active Drug: 20mL of 0.25% Bupivacaine with epinephrine (1:400,000)

Femoral articular branches block(FAB)

FIB Placebo Block: 20mL of Normal Saline Active drug: 20mL of 0.25% Bupivacaine with epinephrine (1:400, 000)

FAB block Placebo Block: 20mL of Normal Saline Active Drug: 20mL of 0.25% Bupivacaine with epinephrine (1:400,000)

Primary outcome measure

  • Dynamic pain score [ Time Frame: 60 minutes after the block procedure ]

Central Contacts and Locations

Central contacts

Locations

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Zhi-bin Wang

9052323369

More Information

Sponsor

University Health Network, Toronto

Last update posted

Mar 19, 2019

Last verified

Jul, 2018

Keywords

  • Fascia Iliaca Block
  • Femoral and Obturator Articular Branch Block

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2019-03-19.