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Analgesic drug study that will compare pain outcomes of opioid analgesia and opioid-free analgesia in post-operative orthopedic patients.
This will be a single center randomized trial. The study will be conducted using block randomization, with two six-month blocks of patient enrollment. The first block will consist of patients undergoing treatment of the above-mentioned fractures with normal standard of care pain management protocol (pre-, intra-, and postoperatively). The second block will consist of patients undergoing treatment the same fractures with opioid-free pain management protocol (pre-, intra-, and postoperatively). Block selection will be determined based on the date of the surgery. However, patients initially assigned to the opioid-free protocol that have CKD/laboratory evidence of poor renal function (ie, elevated BUN/Creatinine) or laboratory evidence of liver function issues (ie, cirrhosis, hypoalbuminemia, elevated liver transaminases, elevated GGT) will crossover to the opioid group as NSAID use and acetaminophen use, respectively, are contraindicated. The use of block randomization will preclude the need for the study coordinator to perform any sort of individual randomization or sealed envelope use for treatment assignment. For subjects who meet eligibility criteria, study informed consent will be obtained at the same time as surgical consent. Patients in the standard of care study block will undergo KUMC's normal pain management strategy. Patients in the opioid-free study block will receive the same pain-management drugs as the opioid group aside from receiving opioids; all other medical care will be standard in this group. Postoperative weightbearing, immobilization, perioperative antibiotics, drain usage, and discharge criteria will be determined by institutional protocols and will remain the same for each block. All patients will be started on postoperative chemical anticoagulation prophylaxis as determined by their fracture pattern and medical comorbidities. Patients will be clinically monitored for signs of venous thromboembolism and appropriate diagnostic screening will be utilized as necessary. Wound complications will be monitored by the treating surgeon and managed as necessary. The study team also plans to record patient specific factors including age, sex, BMI, smoking status, comorbidities, and operative time. These variables will be analyzed independently to detect any correlation with the two pain management protocols.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid pain treatment (Block 1) | No Intervention | Standard of care pain treatment regimen that involves the use of opioids. Discretion of the medical care team and surgeon will be used for specific opioid pain treatment prescription (quantity, frequency) based on standard of care procedures. All forms of treatment are allowed for the standard of care group which may include but are not limited to blocks, opioids, patient-controlled analgesia, NSAIDs, acetaminophen, muscle relaxing agents, sedation medications, and neuropathic pain medications. | |
| Opioid-Free pain treatment (Block 2) | Experimental | Pain treatment regiment without the use of opioids. All other pain medication may be used under the discretion of the medical care team and surgeon. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opioid-free pain treatment | Other | Pain treatment includes any medications up to the medical team's discretion aside from opioids. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Rating Scale (NRS) Pain Scores | Patients will be asked how much pain they are experiencing on a 1-10 scale after their surgery. Lower scores mean better outcomes and less pain, higher scores mean worse outcomes. | From post surgery up until 6 months post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications | Data will be collected on the presence or absence of various complications due to surgery that include: acute kidney injury, subsequent reoperation, amputation, compartment syndrome, surgical site infection, wound dehiscence, nonunion, or venous thromboembolism. | From post surgery up until 6 months post surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Archie Heddings, MD | Contact | 913-588-6164 | aheddings@kumc.edu | |
| Dave Turkowitch, BS | Contact | dturkowitch@kumc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 66103 | United States |
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The study will be conducted using block randomization, with two six-month blocks of patient enrollment. Block selection will be determined based on the date of the surgery.
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| Medication usage (timing) |
The duration of which analgesia is used to treat post-surgical pain will be measured |
| From post surgery up until 6 months post surgery |
| Medication usage (quantity) | The dosage of analgesia used to treat post-surgical pain will be measured | From post surgery up until 6 months post surgery |
| ID | Term |
|---|---|
| D005265 | Femoral Neck Fractures |
| D006620 | Hip Fractures |
| D000092524 | Femoral Fractures, Distal |
| D000092462 | Patella Fracture |
| D064386 | Ankle Fractures |
| D000092483 | Humeral Fractures, Distal |
| D000092470 | Olecranon Fracture |
| D000092467 | Radial Head and Neck Fractures |
| D000092503 | Wrist Fractures |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
| D000092443 | Knee Fractures |
| D016512 | Ankle Injuries |
| D000092482 | Elbow Fractures |
| D000092464 | Elbow Injuries |
| D001134 | Arm Injuries |
| D006810 | Humeral Fractures |
| D014458 | Ulna Fractures |
| D005543 | Forearm Injuries |
| D011885 | Radius Fractures |
| D014954 | Wrist Injuries |
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