Optimization of Analgesia for Hip Fracture Patients

NCT03609645 | Unknown

• 1 other identifier: 17-6067
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Fascia Iliaca Block; Femoral and Obturator Articular Branch Block

Outcome Measures

Primary Outcomes (1)

• Dynamic pain score

  Pain scores will be assessed with an 11-point verbal numeric rating scale (NSR) where 0 is "no pain" and 10 is "the worst pain imaginable" and dynamic pain will be assessed with 15 degrees straight leg raise. The 15 degrees straight leg raise is a safe and standardized test to evaluate dynamic pain in hip fracture patients and has been used in a previous study.

  60 minutes after the block procedure

Secondary Outcomes (4)

• Rest pain score

  30, 60, 120 and 180 minutes post-block

• Dynamic pain score

  30, 120 and 180 minutes post-block

• Cumulative systemic opioid consumption

  1 hour, 3 hours and 24 hours after the block procedure

• Requirement "rescue" intravenous patient controlled analgesia (IV PCA)

  within first 24 hours after the block procedure

Study Arms (2)

Fascia iliaca block (FIB)

ACTIVE COMPARATOR

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

Procedure: Fascia iliaca block

Femoral articular branches block(FAB)

EXPERIMENTAL

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

Procedure: Femoral articular branches block(FAB)

Interventions

Fascia iliaca block PROCEDURE

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)

Fascia iliaca block (FIB)

Femoral articular branches block(FAB) PROCEDURE

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)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Philip Peng, MD

  University Health Network-Toronto Western Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rongyu Jin

CONTACT

4166035800; rongyu.jin@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: An unblinded study personnel not directly involved in patient care will prepare all study drugs. The anesthesiologist, patient, surgeon and the investigator collecting outcome data will be unaware of study group allocation.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a double-blinded randomized prospective study involving patients with hip fracture who are undergoing surgical fixation.

Study Record Dates

• First Submitted: July 25, 2018
• First Posted: August 1, 2018
• Study Start: February 19, 2019
• Primary Completion: September 1, 2019
• Study Completion: January 1, 2020
• Last Updated: March 19, 2019

Record last verified: 2018-07

Locations

CA (1)