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To compare the safety and effectiveness of two pain control pathways following routine orthopaedic surgical procedures (single level or two-level ACDF/ACDA, 1st CMC arthroplasty, Hallux Valgus/Rigidus corrections, diagnostic knee arthroscopies, total hip arthroplasty, and total shoulder arthroplasty / reverse total shoulder arthroplasty). The control group will undergo surgery with an opioid-based pain protocol and the intervention group will undergo surgery with a multimodal, opioid-free protocol.
Patients will have data collected with respect to pain scores, overall comfort level, overall satisfaction with the surgical experience and recovery, constipation, falls, and overall satisfaction with pain control, in addition to procedure-specific outcome scores and patient-specific metrics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid | Active Comparator | The opioid-based arm utilizes traditional, standard-of-care treatment for each applicable surgery. The medications (including dosage and frequency) used in this arm vary depending on the surgery being performed; however, tend to include medications in the opioid family such as Hydromorphone, Hydrocodone, Tramadol, or Oxycodone. |
|
| Opioid-Free | Active Comparator | The opioid-free arm utilizes medications that do not belong to the opioid family of medications. All medications used are FDA-approved and no experimental medications are being used. The medications (including dosage and frequency) used in this arm vary depending on the surgery being performed; however, tend to include medications such as Gabapentin, Tylenol, Meloxicam, Bupivacaine, or Ketorolac. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opioids | Drug | narcotic pain medicine |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain at 24 hours postop | Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pain at 6 hours postop | Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score | 6 hours |
| Pain at 12 hours postop | Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score |
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Inclusion Criteria
1. Patient is scheduled to undergo one of the following procedures:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Nady M Hamid, MD | OrthoCarolina Research Institute, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OrthoCarolina, P.A. | Charlotte | North Carolina | 28207 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33485328 | Derived | Shing EZ, Leas D, Michalek C, Wally MK, Hamid N. Study protocol: randomized controlled trial of opioid-free vs. traditional perioperative analgesia in elective orthopedic surgery. BMC Musculoskelet Disord. 2021 Jan 23;22(1):104. doi: 10.1186/s12891-021-03972-9. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000701 | Analgesics, Opioid |
| D008722 | Methods |
| D018712 | Analgesics, Non-Narcotic |
| ID | Term |
|---|---|
| D009294 | Narcotics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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Parallel Assignment
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| Opioid-Free |
| Drug |
non narcotoc pain medication |
|
|
| 12 hours |
| Pain at 2 weeks postop | Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score | 2 weeks |
| Pain at 6 weeks postop | Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score | 6 weeks |
| Pain at 1 year postop | Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score | 1 year |
| General Health | Veterans Rand-12 | 1 year |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020164 | Chemical Actions and Uses |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D008919 | Investigative Techniques |