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This study will enroll females who are ages 18 and older undergoing a laparoscopic or robotic, partial or full hysterectomy. Participants will be randomized to receive IV n-acetylcysteine or placebo during the first 60 minutes of their procedure. At various time points after the procedure patients will be asked to report their pain scores, and any pain medication taken.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV Placebo | Placebo Comparator | Patients will receive: Placebo 0 mg/kg (placebo: 0.45% NaCl or D5W) through an IV that will run for 60 minutes at the start of the procedure. |
|
| IV N-acetylcysteine | Active Comparator | Patients will receive: N-acetylcysteine (NAC) 150 mg/kg (Max dose 15,000 mg) through an IV that will run for 60 minutes at the start of the procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV N-acetylcysteine | Drug | N-acetylcysteine (NAC) 150 mg/kg (Max dose 15,000 mg) through an IV that will run for 60 minutes at the start of the procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption 0-72 hours post-study medication | 72-hour post-medication opioid consumption. | 0-72 hours after study medication |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores | Using a Visual Analog Scale from 0-100, patients will report pain scores from 0-72 hours post-medication. A lower pain score means a better outcome. | Study medication start to 72 hours post-study medication |
| Measure | Description | Time Frame |
|---|---|---|
| intraoperative opioid consumption | Total morphine milligram equivalents administered during the procedure | during the procedure (up to 12 hours) |
| postoperative anesthesia care unit (PACU) opioid consumption |
Inclusion
Exclusion
Female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haley Nitchie, MHA | Contact | 843-792-1869 | nitchie@musc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sylvia Wilson, M.D. | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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|
| IV Placebo | Drug | Placebo 0 mg/kg (placebo: 0.45% NaCl or D5W) through an IV that will run for 60 minutes at the start of the procedure. |
|
|
Total morphine milligram equivalents administered in the PACU
| PACU Arrival until PACU Discharge up to 52 weeks |
| non-opioid analgesic administration | Total other pain medication administered during the procedure and in PACU | Anesthesia start until PACU discharge up to 52 weeks |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |