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In the current opioid crisis, the use of opioids as the main pain management method is recognized as a consistent risk factor for chronic opioid use and the development of Opioid Use Disorder (OUD), as well as related complications like overdose fatalities among surgical patients. The most recent data suggests that 3.1%-10.5% of surgical patients are at risk of developing OUD. On average, there are over 40 million major surgeries that require post-op pain management, taking place in the United States each year. This puts over 1 million American surgical patients at risk for opioid dependency and misuse.
This is a prospective randomized controlled intervention study that will examine the physical and emotional outcomes of surgical patients who receive intraoperative Opioid-Free Anesthesia (OFA) supplemented with Non-Opioid Analgesia (NOAs), and how this relates to surgical patients who receive intraoperative Opioid-Based Anesthesia (OBA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid-free anesthesia (OFA) Group | Experimental | Subjects enrolled in this arm will receive IV-acetaminophen, IV-lidocaine, dexmedetomidine, and ketamine prior to intubation. |
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| Opioid-based anesthesia (OBA) Group | Active Comparator | Subjects enrolled in this arm will receive IV-acetaminophen, IV-lidocaine, and fentanyl prior to intubation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opioid-free anesthesia | Drug | Each patient will be pre-oxygenated receive IV-acetaminophen (1 g), and IV-lidocaine (60 - 100 mg). and dexmedetomidine (12-20 mcg IV) and ketamine (25-50 mcg) prior to intubation. Induction of anesthesia will be achieved with IV-propofol (1 - 2 mg/kg; 150 - 200 mg). Patient air ways will be secured with an intratracheal tube or LMA. Anesthesia will be maintained by either propofol (100 - 150 mcg/kg/hour; TIVA), or sevoflurane (0.5-1 MAC). During surgery, dexmedetomidine and ketamine will be administered as needed. Anesthesia will be maintained by either propofol (100 - 150 mcg/kg/hour; TIVA), or sevoflurane (0.5-1 MAC). |
| Measure | Description | Time Frame |
|---|---|---|
| PACU Opioid Medication Administered | Medications will be extracted from the electronic medical records. Opioid-based medications will be reported as mean(SD). | Postoperative Day 5 |
| PACU Non-Opioid Medication Administered | Medications will be extracted from the electronic medical records.Non-opioid-based medications will be reported as mean(SD). | Postoperative Day 5 |
| PACU NRS Pain Score at Rest | Numerical Rating Scale (NRS) Pain Scores will be self reported on a scale of 0-10, 0 being no pain at all, 10 being worst pain imaginable. Pain scores at rest will be averaged and reported as mean(SD). | Postoperative Day 5 |
| PACU NRS Pain Score with Movement | Numerical Rating Scale (NRS) Pain Scores will be self reported on a scale of 0-10, 0 being no pain at all, 10 being worst pain imaginable. Pain scores with movement will be averaged and reported as mean(SD). | Postoperative Day 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacques Chelly, MD, PhD, MBA | University of Pittsburgh, UPMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Shadyside Hospital | Pittsburgh | Pennsylvania | 15232 | United States |
De-identified information collected throughout the study will be included in a study database. No patient identifiers will be included in the database and there will be a confidential (access limited to investigators only) code or link between the database and other information about the participant. De-identified data may be shared with additional internal or external data warehouses/investigators and the NIH.
Data may be shared with authorized representatives of the study sponsor and federal regulatory agencies for purposes of monitoring the conduct of this study.
If data is to be shared with other external organizations in the future, the IRB will be modified accordingly, and an appropriate Date Use Agreement will be secured.
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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This is a prospective RCT aiming to examine the effectiveness of OFA on the reduction of postoperative acute and chronic pain and opioid use among 700 adult TKA patients.
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| Opioid-based anesthesia | Drug | Each patient will be pre-oxygenated receive IV-acetaminophen (1 g), and IV-lidocaine (60 - 100 mg). and fentanyl 50-100 mcg IV prior to intubation. Induction of anesthesia will be achieved with IV-propofol (1 - 2 mg/kg; 150 - 200 mg). Patient air ways will be secured with an intratracheal tube or LMA. Anesthesia will be maintained by either propofol (100 - 150 mcg/kg/hour; TIVA), or sevoflurane (0.5-1 MAC). During surgery, each patient in the opioid group will receive IV-fentanyl (50 - 100 mcg) as needed. |
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