Optimization of Analgesia for Hip Fracture Patients

Hip Fractures Clinical Trial

Official title:

Optimization of Analgesia for Hip Fracture: Femoral and Obturator Articular Branch Block vs. Fascia Iliaca Block. A Double-blind, Randomized- Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03609645
• Other study ID #: 17-6067
• Status: Recruiting
• Phase: N/A
• Start date: February 19, 2019
• Est. completion date: January 2020

Study information

• Verified date: July 2018
• Source: University Health Network, Toronto
• Contact: Rongyu Jin
• Phone: 4166035800
• Email: rongyu.jin[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

The anterior hip joint is innervated by articular branches from the femoral nerve (FN), the obturator nerve (ON) and the accessory obturator nerve (AON). The posterior and inferior parts of the hip joint capsule are innervated by the sacral plexus via a) the sciatic nerve, b) the sciatic branch to the quadratus femoris muscle and c) the superior gluteal nerves. Gerhardt et al showed that nociceptive fibers are predominantly present in the anterior and superolateral parts of the joint capsule, suggesting that the femoral and obturator nerves should be the most important nerves to target for hip analgesia.

The 3-in-1 block and FIB are currently used to provide hip analgesia. However, recent MRI imaging studies have shown that proximal local anesthetic spread was not consistent following a 3-in-1 block and did not consistently cover the obturator nerve. Similar findings were reported for the FIB.

A recent study on the innervation of the anterior hip revealed the relevant landmarks for the articular branches of the FN, AON and ON. This study found that high branches of femoral nerve, which were given off superior to the inguinal ligament, play a greater role in the anterior hip innervation than previously reported. These high articular branches of the FN and AON are consistently found between anterior inferior iliac spine (AIIS) and iliopubic eminence (IPE). With the help of ultrasound imaging, these landmarks can be identifiable and it is possible to target them directly in order to provide hip analgesia.

These recent data suggests that blocking these branches as they course deep to the iliopsoas muscle should result in superior hip joint analgesia compared to a FIB since the local anesthetic spread from a FIB is neither proximal nor deep enough to cover these articular branches consistently. Real-time ultrasound can help identify these proximal FN and AON branches using the anterior inferior iliac spine and the iliopubic eminence as landmarks.

The overall aim of this study is to determine in a prospective, randomized, double blind manner, the analgesic profile associated with two different regional anesthetic techniques: (1) FIB and (2) Femoral articular branches (FAB) block.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

Procedure:
• 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)

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rest 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.	30, 60, 120 and 180 minutes post-block
Secondary	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.	30, 120 and 180 minutes post-block
Secondary	Cumulative systemic opioid consumption	oral morphine mg equivalents	1 hour, 3 hours and 24 hours after the block procedure
Secondary	Requirement "rescue" intravenous patient controlled analgesia (IV PCA)	If oral pain medication and block is not enough patient can get IV PCA.We will be recording requirement of IV PCA anytime in the first 24 hours after the block procedure.	within first 24 hours after the block procedure