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Local Multimodal Injection Versus Regional Anesthesia in Controlling Pain for Treating Rotational Ankle Fractures

Primary Purpose

Ankle Fractures

Status
Enrolling by invitation
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Regional anesthesia group
Local multimodal analgesia group
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Fractures focused on measuring rotational ankle fractures, regional anesthesia, local multimodal injection, pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • isolated rotational ankle fracture
  • operative intervention needed
  • English or Spanish speaking
  • provide informed consent
  • able to communicate with the research team via email or phone

Exclusion Criteria:

  • sustain concomitant head injury
  • additional lower extremity fracture(s)
  • open fracture
  • prior drug dependency
  • allergies to any of the ingredients in the local injection or peripheral nerve block
  • any history of stroke
  • major neurological deficit

Sites / Locations

  • University of Utah Orthopaedic Center
  • University of Utah Orthopedics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Regional anesthesia group

Local multimodal analgesia group

Arm Description

Standard single-shot anesthesia consists of bupivacaine 0.25% with epinephrine 1:400,000.

Local multimodal analgesia composition will include 5mg of morphine, 500 mg of epinephrine, 15mg of ketorolac, and 20mg of bupivacaine.

Outcomes

Primary Outcome Measures

Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)

Secondary Outcome Measures

Full Information

First Posted
July 19, 2021
Last Updated
March 13, 2023
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT05019638
Brief Title
Local Multimodal Injection Versus Regional Anesthesia in Controlling Pain for Treating Rotational Ankle Fractures
Official Title
Evaluating the Effectiveness of Local Multimodal Injection in Controlling Pain, Limiting Complications, and Reducing Cost as Compared to Regional Anesthesia for Treating Rotational Ankle Fractures.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 15, 2021 (Actual)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators plan to evaluate the efficacy in reducing post-operative pain between local multimodal analgesia as compared to regional anesthesia in rotational ankle fractures.
Detailed Description
Pain control is a chief domain in patient-centered care and may play a key role in outcome-driven reimbursement as a focus on payment strategies shifts in this direction. The Center for Medicaid and Medicare Services has developed the Total Performance Score for Hospitals, which is factored into the reimbursement for provided services. Pain Management is one of the main contributors to the score. Moreover, pain control has been shown to improve patient satisfaction, which is of increasing importance in medicine today. The United States is in the midst of an opioid epidemic where we consume 80% of the world's narcotics with only 5% of the world's population. Prescription opioids may play a major role in up to 40% of opioid overdose deaths. Orthopedic surgeons are the top prescribing surgical specialists and the fourth-largest overall prescriber of narcotic medication, representing 7.7% of total opioid prescriptions. Given the magnitude and implications of the opioid epidemic, orthopedic surgeons have been tasked with delivering adequate pain control while avoiding excessive narcotic prescriptions that can lead to opioid addiction and opioid-related deaths. Regional anesthesia has been extensively studied for operatively managed rotational ankle fractures. Foot and ankle surgery patients receiving regional anesthesia have been reported to have lower pain scores and less narcotic usage for up to 8 weeks post-operatively. In a prospective cohort study of ankle fracture patients, Investigators have demonstrated improved pain management in patients who received single-shot regional anesthesia as compared to control patients. In a blinded, prospective, randomized controlled trial, it was reported lower pain scores and longer analgesia in patients receiving peripheral nerve block as compared to control patients. Local multimodal analgesia has been used extensively in the setting of total knee arthroplasty. Numerous studies have investigated the effect of these injections and shown a decrease in perioperative pain and the use of perioperative narcotics. A team of investigators looked at multimodal analgesia injections in femur fractures of all kinds. They found that in patients receiving the injection, their pain was decreased over the first postoperative day along with consuming fewer narcotics over the same time frame. Unfortunately, the randomization in this study resulted in an unequal distribution of injuries that may have biased the results. It was noted, "further investigations are required to establish the efficacy of this multimodal protocol for the individual surgical procedures considered." Several aspects of the proposed study are innovative and the results of which will provide evidence for significant change. The proposed studies focuses on one of the most common skeletal injuries treated with surgical intervention by orthopaedic surgeons. These investigators are thus focusing on an area with widespread implications where a small change in practice could result in extensive change through the system. The overarching goal for this investigation is to optimize postoperative pain control delivery while limiting narcotic medication consumption. There are currently no studies that compare the effectiveness and cost between local multimodal analgesia and regional anesthesia as it relates to rotational ankle fractures. Despite extensive use in arthroplasty, local multimodal analgesia has limited usage in the setting of fracture or acute injury. This represents a significant area of innovation and growth in the realm of orthopaedic traumatology. Given the commonplace nature of ankle fractures and the ability to perform regional anesthesia given the lack of compartment syndrome risk, these injuries represent the ideal candidate to explore a new mode of postoperative analgesia. Additionally, incorporating an anti-inflammatory medication into the local multimodal injection cocktail is novel. While a stigma associated with anti-inflammatory medications and impaired bone healing exist, single usage should be relatively low risk while providing significant local pain relief. The ability of local multimodal analgesia to provide similar pain control as regional anesthesia would expand the possibility of using local multimodal analgesia in locations that do not have an appropriately trained anesthesiologist for regional anesthesia. It may also improve the workflow and open the possibility of investigation as it relates to other common fractures. The hypothesis is that ankle fracture patients with post-operative local multimodal analgesia will have similar Visual Analog Scale (VAS) pain scores as patients with post-operative regional anesthesia at 24 hours post-surgery. Secondary analyses will compare VAS pain scores at 1, 2, 4, and 8 hours post-operatively in addition to post-operative narcotic usage between the two groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Fractures
Keywords
rotational ankle fractures, regional anesthesia, local multimodal injection, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Regional anesthesia group
Arm Type
Active Comparator
Arm Description
Standard single-shot anesthesia consists of bupivacaine 0.25% with epinephrine 1:400,000.
Arm Title
Local multimodal analgesia group
Arm Type
Experimental
Arm Description
Local multimodal analgesia composition will include 5mg of morphine, 500 mg of epinephrine, 15mg of ketorolac, and 20mg of bupivacaine.
Intervention Type
Drug
Intervention Name(s)
Regional anesthesia group
Other Intervention Name(s)
Marcaine (bupivacaine), Adrenalin (epinephrine)
Intervention Description
bupivacaine 0.25% with epinephrine 1:400,000.
Intervention Type
Drug
Intervention Name(s)
Local multimodal analgesia group
Other Intervention Name(s)
MS Contin, Astramorph, Depodur, Duramorph, Infumorph, Kadian, MorphaBond, Arymo ER (morphine), Adrenalin (epinephrine), Toradol (ketorolac), Marcaine (bupivacaine)
Intervention Description
5mg of morphine, 500 mg of epinephrine, 15mg of ketorolac, and 20mg of bupivacaine.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS) pain
Description
VAS pain score (0 no pain - 10 severe pain)
Time Frame
Pre-operative
Title
Visual Analog Scale (VAS) pain
Description
VAS pain score (0 no pain - 10 severe pain)
Time Frame
1-hour post-operative
Title
Visual Analog Scale (VAS) pain
Description
VAS pain score (0 no pain - 10 severe pain)
Time Frame
2-hour post -operative
Title
Visual Analog Scale (VAS) pain
Description
VAS pain score (0 no pain - 10 severe pain)
Time Frame
4-hour post-operative
Title
Visual Analog Scale (VAS) pain
Description
VAS pain score (0 no pain - 10 severe pain)
Time Frame
8-hour post-operative
Title
Visual Analog Scale (VAS) pain
Description
VAS pain score (0 no pain - 10 severe pain)
Time Frame
24-hour post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: isolated rotational ankle fracture operative intervention needed English or Spanish speaking provide informed consent able to communicate with the research team via email or phone Exclusion Criteria: sustain concomitant head injury additional lower extremity fracture(s) open fracture prior drug dependency allergies to any of the ingredients in the local injection or peripheral nerve block any history of stroke major neurological deficit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin Haller, MD
Organizational Affiliation
University of Utah Orthopaedics
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah Orthopaedic Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
University of Utah Orthopedics
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Local Multimodal Injection Versus Regional Anesthesia in Controlling Pain for Treating Rotational Ankle Fractures

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