Opioid Use Clinical Trial
Official title:
Prospective Non-Randomized Interventional Pilot Study of the Effects of Early Administration of Ultrasound Guided Regional Anesthesia for Long Bone Fractures on Long Term Patient Opioid Usage
Administration of ultrasound guided peripheral nerve blocks is a procedural skill set that falls within the scope of Emergency Medicine practice. Extrapolating evidence from Anesthesia and Orthopedic literature (which shows decreased post-operative opioid use by surgical patients who receive regional anesthesia as part of their pre and perioperative pain management strategy) the investigators believe that early administration of regional anesthesia for long bone fractures by providers in the ED may have an as of yet unidentified positive impact on long term opioid use. If this is indeed found to be the case, early administration of regional anesthesia for extremity fractures would represent an area of focus for ED providers in the national effort by the medical community to combat opioid abuse.
The investigators will perform a small prospective non-randomized interventional pilot study
to assess feasibility of a future full scale RCT to test the hypotheses. Interventional study
subjects will be compared to controls enrolled simultaneously during the study period who
meet the inclusion criteria and do not have documentation of one of the exclusion criteria.
The investigators will enroll subjects 2 controls to 1 intervention to ensure the ability to
select controls as similar to the intervention population as possible. The study is powered
for an alpha of 0.9 and an effect size (standardized difference) of 0.2. The total subjects
needed to enroll is 36 with 18 subjects in each arm of the study. However, in an attempt to
obtain controls as closely matched to our intervention group as possible 36 controls will be
enrolled.
A. Subject Selection
Intervention subjects will be enrolled as a convenience sample when physicians participating
in the study are available in the ED. Controls will be enrolled when no study participating
physicians are available in the ED. Potential subjects will be selected for enrollment by
research team members directly from the trauma bay or from the tracking board when they are
identified as having a qualifying fracture. They will be screened for exclusion and inclusion
criteria by the research assistants. The goal will be to enroll patients within 2 hours of
arrival in the ED.
Inclusion Criteria:
- patients 18 years of age or older
- presentation to the emergency department with isolated fractures of the hip or proximal
femur, mid or distal humerus, radius, or ulna
- poly-trauma patients with one of the previously listed fractures who do not meet
exclusion criteria
Exclusion Criteria:
- Allergy to upivacaine/ropivicaine or other amide anesthetics
- evidence of compartment syndrome on exam by physician
- infection over injection site
- previously documented opioid abuse or dependence in the last year as documented in the
EMR or self-reported by the patient
- current documented opioid prescription in the EMR
- patient is intubated or unable to provide consent
- poly-trauma patients with abdominal, thoracic or neurologic injury requiring operative
intervention at the time of presentation to the ED
3a. Consent: If the patient qualifies for study inclusion a research assistant will
obtain patient written consent to: receive a nerve block placed by a trained physician
participating in the study, allow for access of their medical record for purposes of
data collection for the study and collect patient contact information for follow up
communication related to the study after discharge. The patient will be informed that
should they complete all the follow up information as part of this study they will
receive a monetary incentive for participation in person at their final follow up, 30
days after the nerve block.
After patients are consented either a supraclavicular brachial plexus block or fascia iliaca
nerve block (determined by site of injury) will be performed by an ultrasound trained faculty
member, ultrasound fellow or resident who has undergone specific training to perform the
blocks included in this study. The research team will be given a list of physicians qualified
to perform the selected blocks for this study.
B. Interventions
Prior to administering a nerve block to an enrolled patient a complete neurovascular exam
will be performed and documented on a paper form that will be kept in the patient's chart for
review by orthopedic surgery and/or trauma surgery if needed while the patient is admitted.
Any questionable exam findings will be discussed in conjunction with orthopedic surgery
and/or trauma surgery prior to block administration.
1. b. Supraclavicular block Investigators will follow the techniques outlined by Gamo et al
and NYSORA (New York School of Regional Anesthesia) for placement of supraclavicular
blocks [9,21]. Patients will be placed in the supine position on a stretcher, with their
arms by their sides and head rotated to the side opposite to that of their injury, at an
angle of 45° from the midline. There will be continuous cardiac and pulse oximetry
monitoring throughout the procedure. Towels may be placed under the shoulder on the side
of the injection to improve neck exposure for block placement. The neck will be prepped
with Chlorhexidine antiseptic and sterile technique will be utilized during block
placement. Blocks will be performed under ultrasound guidance using a high frequency
linear probe on a Zonare machine with a sterile probe cover. The ultrasound probe will
be positioned behind the clavicle in the supraclavicular fossa and pointed
inferior-medially. The subclavian artery will be identified in the short axis by its
rounded shape and pulsatility. The brachial plexus in this location will be identified
by its proximity to the subclavian artery as it typically lies superficial and
posterior-lateral to this vessel. Once the plexus is identified a clip of the plexus
will be saved and uploaded to QPath for documentation. A local skin wheal of 0.5%
bupivacaine will be made with a 27-guage needle 2 cm lateral to the US probe at the site
of entry for the nerve block. An 'in-plane' technique will be used for visualizing the
needle for block placement. A 20 or 22-gauge non-cutting needle will be introduced from
lateral to medial and placed in-line with and parallel to the probe. The needle will
inserted deep between the subclavian artery and the first rib, inferior to the brachial
plexus; subsequently, 2 ml to 3 ml of 0.5% Bupivacaine will be injected very carefully
to avoid accidental intravascular injection. The needle will be redirected from deep to
intermediate and superficial levels in order to allow maximum spread of local anesthetic
around the nerve bundle. By the end of the procedure, a total of 20 ml to 25 ml of 0.5%
bupivacaine local anesthetic will be injected. A second clip will be saved on the Zonare
and uploaded to QPath after completing the block to demonstrate the area of anesthetic
introduced. Following block application patient will receive care for their injury as
determined by their EM physician while in the ED and/or their admitting physician if
admitted to the hospital.
2. b. Fascia Iliaca block Investigators will follow the techniques outlined by Beaudoin et
al and NYSORA for placement of Fascia Iliaca blocks [13, 22]. There will be continuous
cardiac and pulse oximetry monitoring throughout the procedure. Patient will be
positioned supine on a stretcher in slight trendelenberg. Blocks will be performed under
ultrasound guidance using a high frequency linear probe on a Zonare machine with a
sterile probe cover. The inguinal region on the corresponding side of injury will be
prepped with Chlorhexidine antiseptic and sterile technique will be utilized during
block placement. The US probe will be placed 1 cm distal to the inguinal ligament on the
side of the injured lower extremity to identify the femoral vessels and the nerve in
cross section. The nerve will be identified as an isolated hyperechoic structure
approximately 1 cm lateral to the pulsatile femoral artery. A clip of the identified
nerve will be saved and uploaded to QPath for documentation. A local skin wheal of 0.5%
bupivacaine will be made with a 27-guage needle 2 cm lateral to the US probe at the site
of entry for the nerve block. At the skin wheal site, a 20 or 22-gauge noncutting spinal
needle will be introduced at a 45° angle in-plane to the US probe and 20-25 mL of 0.5%
bupivacaine will injected along the nerve sheath. The needle will be directly visualized
throughout the procedure to ensure there is no vascular puncture and that spread of 0.5%
Bupivacaine is administered in the correct fascial plane. A second clip will be saved on
the Zonare and uploaded to QPath after completing the block to demonstrate the area of
anesthetic introduced. Following block application patient will receive care for their
injury as determined by their EM physician while in the ED and/or their admitting
physician if admitted to the hospital.
3. b. Procedure Risks The possible risks associated with placement of nerve blocks while
low in incidence, include possible risk of injury to vascular or nerve structures or
accidental intravascular deposition of anesthetic [8,9,13,21,22]. Additional risk with
the supraclavicular block includes a slight chance for pneumothorax. By placing these
nerve blocks with ultrasound guidance it significantly reduces the risk of the
aforementioned complications as the needle tip location is constantly visualized on
screen [8,21,22]. This including decreasing the risk for pneumothorax with the
supraclavicular block as the lung pleura and needle tip can be continuously visualized
by ultrasound and thus help avoid accidental puncture [8,9,21]. Additionally,
investigators will utilize non-cutting spinal needles for this study as this measure has
been noted in previous nerve block studies to reduce the risk of accidental venous or
arterial puncture and lessens the chance of injury to the epineurium of nerve bundles
[9,13,21,22]. There is always the risk of allergy to bupivacaine though this is rare.
Investigators will attempt to avoid allergic reactions by patients undergoing blocks by
screening for allergy to amide anesthetics (the family of drugs that Bupivacaine belongs
to) at time of enrollment.
C. Subject Follow Up
1. c. First 24hrs All study patients will have a reported pain score assessed using a
validated pain score tool (VAS) by the research team once prior to leaving the ED. A
research assistant will obtain a patient reported pain score at 24hrs after block
application. While patient is admitted their utilized opioid pain medications will be
tracked in the EMR and their daily MME usage will be calculated and recorded. The
investigators will evaluate patient opioid usage by calculating Morphine Milligram
Equivalents using CMS guidelines for conversion.
2. c. Follow up at 1 week At 7 days after block placement patients will be contacted by
phone by the research team or in person if they are still hospitalized. Assistants will
ask patients to report a pain score for their injury, any new injuries requiring opioid
pain medication since discharge, and current opioid usage via prescribed narcotics or
illicit drug use. The patient will be asked to report a pill count of their current
opioid prescription (if any). Pharmacy reported prescriptions will be pulled for each
patient at 7 days after initial block placement using the "External Rx History" tab
under power orders in the EMR. The investigators will evaluate patient opioid usage by
calculating Morphine Milligram Equivalents using CMS guidelines for conversion. At that
time subjects who received a nerve will also be asked questions regarding their
satisfaction with their pain control and care after receiving the nerve blocks. Subjects
who did not receive a nerve block will be asked the same questions about satisfaction
with pain control and will be asked about satisfaction with their care. All subjects
will be asked if they have scheduled any doctor's appointments or presented to an urgent
care or emergency department for the sole purpose of obtaining care for pain control for
their injury.
3. c. Final follow up at 30 days At 30 days after block placement patients will be
contacted by phone for a final survey by the research team. If subjects are still
hospitalized they will be assessed by a research assistant in the hospital. Assistants
will ask patients to report a pain score for their injury, any new injuries requiring
opioid pain medication since discharge, and current opioid usage via prescribed
narcotics or illicit drug use. The patient will be asked to report a pill count of their
current opioid prescription (if any). Pharmacy reported prescriptions will be pulled for
each patient at 30 days after initial block placement using the "External Rx History"
tab under power orders in the EMR. Investigators will evaluate patient opioid usage by
calculating Morphine Milligram Equivalents using CMS guidelines for conversion. At that
time subjects who received a nerve will also be asked questions regarding their
satisfaction with their pain control and care after receiving the nerve blocks. Subjects
who did not receive a nerve block will be asked the same questions about satisfaction
with pain control and will be asked about satisfaction with their care. All subjects
will be asked if they have scheduled any doctor's appointments or presented to an urgent
care or emergency department for the sole purpose of obtaining care for pain control for
their injury. At the time of this final follow up participating patients will receive an
incentive gift card for participation. Transportation to this final follow up visit will
be arranged and paid for by the research department.
D. Data Collection and Interpretation
Data on each subject will be collected by research assistants and stored in a secure,
de-identified REDCap database/spreadsheet. Data points collected will include: age, sex,
fracture type, history of opioid abuse or opioid prescription, history if IV drug use, type
of nerve block administered, and location of block placement. At follow up points data will
be collected on patient reported pain scores using the VAS scoring system. Self reported
opioid use, pill counts and reported healthcare visits for pain from initial injury will be
recorded and stored. Data will be collected at follow ups on patient satisfaction using
surveys that have Likert scaled questions. Data will be collected directly from the EMR at
previously outlined points documenting each subjects opioid prescriptions and opioid use.
A statistician from the Wayne State Research Department will be utilized for data
interpretation after collection of data from subjects.
E. Study Timeline
This pilot study will be conducted over a span of 12 months. The initial 6 weeks will be
utilized providing study training to the participating research assistants. This time will
also be spent providing block training, skills assessments and teaching to participating
physicians. The following 8 months will be spent enrolling subjects and collecting data. The
remaining 2 months and 2 weeks will be used for data interpretation and creation of a
manuscript for submission detailing findings from this study.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04095624 -
Does Preoperative Pain Medication Management Influence Surgical Outcomes in Spinal Fusion
|
N/A | |
Completed |
NCT04484610 -
Appropriate Opioid Quantities for Acute Pain - Pharmacist Study
|
Phase 4 | |
Recruiting |
NCT04598074 -
Opioid Package Prototype (OPP)
|
N/A | |
Recruiting |
NCT06033599 -
Motivational Interviewing and Mindfulness-Oriented Recovery Enhancement
|
Phase 3 | |
Recruiting |
NCT06032559 -
Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment
|
Phase 3 | |
Completed |
NCT05845177 -
Persistent Pain After Hip Replacement
|
||
Completed |
NCT03268551 -
MEMO-Medical Marijuana and Opioids Study
|
||
Completed |
NCT03570320 -
Does Altering Narcotic Prescription Methods Affect Opioid Distribution Following Select Upper Extremity Surgeries?
|
N/A | |
Completed |
NCT04526236 -
Influence of Aging on Perioperative Methadone Dosing
|
Phase 4 | |
Completed |
NCT05593341 -
Opioid Education in Total Knee Arthroplasty
|
N/A | |
Recruiting |
NCT05877157 -
Pain AND Opioids After Surgery
|
||
Recruiting |
NCT06055205 -
A Pain and Coordination Plan for Reduced Opioid Use After Accidental Injuries
|
N/A | |
Recruiting |
NCT03675386 -
Reducing Opioid Use for Chronic Pain Patients Following Surgery
|
N/A | |
Suspended |
NCT05001789 -
Cognitive Functioning in Opioid Use Disorder
|
N/A | |
Completed |
NCT04296396 -
Opioid Prescription After Cesarean Trial
|
Phase 3 | |
Not yet recruiting |
NCT04868552 -
Naloxone Education in Total Joint Patients
|
N/A | |
Completed |
NCT03540030 -
Opioid-Free Shoulder Arthroplasty
|
Phase 4 | |
Terminated |
NCT06217380 -
Feasibility and Acceptability of Oxygen Saturation Monitoring Using Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program
|
N/A | |
Recruiting |
NCT05976646 -
Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion
|
Phase 1/Phase 2 | |
Completed |
NCT03472521 -
Prevention of Persistent Opioid Use in Mothers
|
Phase 4 |