Role of Multimodal Analgesia in Decreasing Perioperative Pain in Tibial Plateau Fractures
Primary Purpose
Tibial Plateau Fractures
Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Saline injection
Multimodal injections
Sponsored by
About this trial
This is an interventional treatment trial for Tibial Plateau Fractures focused on measuring Tibial Plateau Fractures, Periarticular Multimodal Analgesia, Perioperative Pain
Eligibility Criteria
Inclusion Criteria:
- Patients who present with isolated tibial plateau fractures treated by the investigators
- English or Spanish speaking
Exclusion Criteria:
- Poly trauma injuries
- Any allergies to the medication used in the injections
- Significant head trauma (loss of consciousness, Glasgow Coma Scale (GCS)<15, brain bleed) that interferes with the ability to provide informed consent.
- Non-English or Non-Spanish Speaking
Sites / Locations
- University of Utah Orthopaedic Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Saline injection
Multimodal injections
Arm Description
Saline
Superficial multimodal analgesia composition includes 5mg morphine, 500 micrograms epinephrine, and 4ml normal saline. Deep medial multimodal analgesia composition includes 2.5mg morphine, 40 micrograms clonidine, 15mg ketorolac, and 4ml normal saline.
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)
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05037812
Brief Title
Role of Multimodal Analgesia in Decreasing Perioperative Pain in Tibial Plateau Fractures
Official Title
Determining the Role of Periarticular Multimodal Analgesia in Decreasing Perioperative Pain in Tibial Plateau Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 25, 2019 (Actual)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
March 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 goal of the proposed research study is to determine the effectiveness of periarticular multimodal analgesia in the setting of tibial plateau fractures. Effectiveness of the multimodal analgesia is defined as lower pain scores.
Detailed Description
Pain control in the setting of orthopaedic trauma has always been imperative for patient comfort and to enhance functional recovery. However, the current opioid epidemic makes effective pain control even more critical. Furthermore, the Center of Medicare and Medicaid Services have developed tools for rating physician care, of which, pain control is considered a contributing part. The operative management of tibial plateau fractures requires adequate pain control to allow for early motion of the joint. Recently, multimodal pain therapy has been proposed as way to accomplish effective postoperative pain relief. This is difficult for this injury as any form of regional analgesia such as nerve blocks are not possible due to the possibility of compartment syndrome. The goal of the proposed research study is to determine the effectiveness of periarticular multimodal analgesia in the setting of tibial plateau fractures. Effectiveness of the multimodal analgesia is defined as lower pain scores and decreased narcotic intake in the perioperative setting.
The expected outcomes of the study are based on the extensive total knee arthroplasty literature that shows decreased pain and narcotic usage in the peri-operative period with peri-articular multimodal analgesia injections. Furthermore, a recent study by other investigators showed decreased pain and narcotic usage in the first post-operative day following femur fractures of any kind. These data display the promise for the use of peri-articular multimodal analgesia in the setting of tibial plateau fractures.
With the rise of patient-centered care and outcome driven reimbursement, pain control is one of the main factors in both these domains. 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.
While some lower extremity fractures can be managed with a nerve block, tibial plateau fractures have a significant risk of developing compartment syndrome that preclude these patients from receiving a nerve block as it does not allow clinical monitoring. As such, the remaining options are to control pain with IV and oral narcotics.
There is no data on the effectiveness of peri-articular multimodal analgesia for tibial plateau fractures. The majority of evidence behind these injections in reducing peri-operative pain and decreasing narcotic use comes from the total knee arthroplasty literature. Numerous studies have investigated the effect of these injections and shown a decrease in perioperative pain and use of perioperative narcotics.
Investigators have looked at multimodal analgesia injections in femur fractures of all kinds. The investigators 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 these studies resulted in an unequal distribution of injuries that may have biased the results. The investigators noted, "further investigations are required to establish the efficacy of this multimodal protocol for the individual surgical procedures considered". Five patients with tibial plateau fractures have experimentally been treated with a local multimodal analgesia at the applying institution. All five have had a subjectively decreased amount of pain with no evidence of peroneal nerve palsy, compartment syndrome, or infection. If the proposed study finds similar results in decreasing pain and narcotic use, not only would patients have an overall better experience, but this would also help in decreasing narcotic related adverse events in the hospital.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibial Plateau Fractures
Keywords
Tibial Plateau Fractures, Periarticular Multimodal Analgesia, Perioperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Saline injection
Arm Type
Placebo Comparator
Arm Description
Saline
Arm Title
Multimodal injections
Arm Type
Experimental
Arm Description
Superficial multimodal analgesia composition includes 5mg morphine, 500 micrograms epinephrine, and 4ml normal saline.
Deep medial multimodal analgesia composition includes 2.5mg morphine, 40 micrograms clonidine, 15mg ketorolac, and 4ml normal saline.
Intervention Type
Drug
Intervention Name(s)
Saline injection
Other Intervention Name(s)
0.9%NaCl (sodium chloride) H2O (saline)
Intervention Description
Saline
Intervention Type
Drug
Intervention Name(s)
Multimodal injections
Other Intervention Name(s)
Morphine sulfate (MS) Contin, Astramorph, Depodur, Duramorph, Infumorph, Kadian, MorphaBond, Arymo ER (morphine), Adrenalin (epinephrine), Catapres, Kapvay (clonidine), Toradol (ketorolac), 0.9%NaCl (sodium chloride) H2O (saline)
Intervention Description
5mg morphine, 500 micrograms epinephrine, and 4ml normal saline (superficial injection).
2.5mg morphine, 40 micrograms clonidine, 15mg ketorolac, and 4ml normal saline (deep injection).
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
4-hours post-operative
Title
Visual Analog Scale (VAS) pain
Description
VAS pain score (0 no pain - 10 severe pain)
Time Frame
8-hours post-operative
Title
Visual Analog Scale (VAS) pain
Description
VAS pain score (0 no pain - 10 severe pain)
Time Frame
12-hours post-operative
Title
Visual Analog Scale (VAS) pain
Description
VAS pain score (0 no pain - 10 severe pain)
Time Frame
16-hours post-operative
Title
Visual Analog Scale (VAS) pain
Description
VAS pain score (0 no pain - 10 severe pain)
Time Frame
20-hours post-operative
Title
Visual Analog Scale (VAS) pain
Description
VAS pain score (0 no pain - 10 severe pain)
Time Frame
24-hours post-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who present with isolated tibial plateau fractures treated by the investigators
English or Spanish speaking
Exclusion Criteria:
Poly trauma injuries
Any allergies to the medication used in the injections
Significant head trauma (loss of consciousness, Glasgow Coma Scale (GCS)<15, brain bleed) that interferes with the ability to provide informed consent.
Non-English or Non-Spanish Speaking
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
12. IPD Sharing Statement
Plan to Share IPD
No
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Role of Multimodal Analgesia in Decreasing Perioperative Pain in Tibial Plateau Fractures
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