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Optimization of Analgesia for Hip Fracture Patients

Primary Purpose

Hip Fractures

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Fascia iliaca block
Femoral articular branches block(FAB)
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hip Fractures focused on measuring Fascia Iliaca Block, Femoral and Obturator Articular Branch Block

Eligibility Criteria

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

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

Sites / Locations

  • Toronto Western HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Fascia iliaca block (FIB)

Femoral articular branches block(FAB)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Cumulative systemic opioid consumption
oral morphine mg equivalents
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.

Full Information

First Posted
July 25, 2018
Last Updated
March 15, 2019
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT03609645
Brief Title
Optimization of Analgesia for Hip Fracture Patients
Official Title
Optimization of Analgesia for Hip Fracture: Femoral and Obturator Articular Branch Block vs. Fascia Iliaca Block. A Double-blind, Randomized- Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 19, 2019 (Actual)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
Keywords
Fascia Iliaca Block, Femoral and Obturator Articular Branch Block

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a double-blinded randomized prospective study involving patients with hip fracture who are undergoing surgical fixation.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fascia iliaca block (FIB)
Arm Type
Active Comparator
Arm Description
Group will receive Fascia iliaca block (FIB) with local anesthetic and femoral articular branch block (FAB) with normal saline (Placebo).
Arm Title
Femoral articular branches block(FAB)
Arm Type
Experimental
Arm Description
Group will receive Fascia iliaca block (FIB) with normal saline (Placebo) and Femoral AON articular branch block (FAB) with local anesthetic.
Intervention Type
Procedure
Intervention Name(s)
Fascia iliaca block
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
Femoral articular branches block(FAB)
Intervention Description
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 Information:
Title
Dynamic pain score
Description
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.
Time Frame
60 minutes after the block procedure
Secondary Outcome Measure Information:
Title
Rest pain score
Description
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.
Time Frame
30, 60, 120 and 180 minutes post-block
Title
Dynamic pain score
Description
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.
Time Frame
30, 120 and 180 minutes post-block
Title
Cumulative systemic opioid consumption
Description
oral morphine mg equivalents
Time Frame
1 hour, 3 hours and 24 hours after the block procedure
Title
Requirement "rescue" intravenous patient controlled analgesia (IV PCA)
Description
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.
Time Frame
within first 24 hours after the block procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rongyu Jin
Phone
4166035800
Ext
2016
Email
rongyu.jin@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Peng, MD
Organizational Affiliation
University Health Network-Toronto Western Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhi-bin Wang
Phone
9052323369

12. IPD Sharing Statement

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Optimization of Analgesia for Hip Fracture Patients

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