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Effective non-opioid analgesics are of particular interest in ambulatory surgery, as providers may be able to reduce pain while avoiding perioperative opioids that can delay same day discharge. The value of maintaining an efficient flow of patients from the perioperative area to discharge is an important metric for same day surgery centers, and an improvement in efficiency with IV acetaminophen could potentially offset the increased cost of the medication while providing a more pleasant surgical experience for patients. The goal of this study is to compare the efficacy of intraoperative IV administration vs. preoperative oral administration of acetaminophen on postoperative opioid utilization, patient-reported pain scores, opioid-related adverse effects, and time to recovery and discharge from the post-anesthesia care unit (PACU) after ambulatory lumbar discectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: IV acetaminophen and PO placebo | Active Comparator | Group 1 will receive 1000 mg of IV acetaminophen approximately 30 minutes prior to skin closure and will receive oral placebo in the holding area prior to surgery |
|
| Group 2: PO acetaminophen | Active Comparator | Group 2 will receive 1000 mg of PO acetaminophen in the holding area and will not receive an IV placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug | 1000 mg of oral acetaminophen preoperatively administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative opioid usage | Postoperative opioid usage over the first 24 hours will be reported in IV morphine equivalents | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of recovery | assessed using the Quality of Recovery 15 scale, with a range of 0-150 (0 is the worst score and 150 is the best possible recovery) | 1 day |
| Number of patients who report nausea or vomiting |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rothman Orthopaedic Institute | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38499358 | Derived | Schwenk ES, Ferd P, Torjman MC, Li CJ, Charlton AR, Yan VZ, McCurdy MA, Kepler CK, Schroeder GD, Fleischman AN, Issa T. Intravenous versus oral acetaminophen for pain and quality of recovery after ambulatory spine surgery: a randomized controlled trial. Reg Anesth Pain Med. 2025 Jun 10;50(6):483-488. doi: 10.1136/rapm-2024-105386. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Only those performing postoperative assessments and the participants will be blinded.
this will be a count of the number of patients who report nausea or vomiting in recovery room
| 1 day |
| Mean pain score | (0-10 numerical rating scale where 0=no pain and 10=worst pain imaginable) - this will be the mean pain rating upon entering pacu and at least 1 other time point in each study group | 1 day |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |