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Hypothesis: Postoperative pain will be equivalent in patients receiving preemptive oral acetaminophen as compared to patients receiving preemptive intravenous acetaminophen following minimally invasive benign gynecologic surgery.
Primary outcome:
• Difference in postoperative pain comparing preemptive use of PO versus IV acetaminophen
o Mean Visual analog Scale (VAS) scores will be compared between the intervention group (PO acetaminophen) and the control group (IV acetaminophen).
Secondary outcomes:
Difference in postoperative analgesic use between groups
o Narcotics, NSAIDs
Difference in postoperative N/V between groups
o Patient rated measure - none, mild, moderate, severe
Cost comparison between drugs
Hypothesis: Postoperative pain will be equivalent in patients receiving preemptive oral acetaminophen as compared to patients receiving preemptive intravenous acetaminophen following minimally invasive benign gynecologic surgery.
Importance/significance: Adequate control of postoperative pain is important for patient satisfaction, adequate healing, and optimizing length of stay. The idea of preemptive analgesia (giving an analgesic prior to first skin incision to prevent sensitization of nerve pathways from the trauma of surgery) has been shown in many studies to improve postoperative pain. Intravenous acetaminophen has been found to be an effective agent when given preemptively, and many surgeons have adopted this practice. Unfortunately, the IV formulation of acetaminophen, unlike the oral formulation, is expensive as it is a relatively new drug. There are other oral analgesics (i.e. Celebrex) that have been found to be efficacious for postoperative pain control when given preemptively. There are no studies in gynecologic surgery, however, comparing the effectiveness of PO acetaminophen with IV acetaminophen. Given that PO acetaminophen is significantly cheaper than the IV formulation, this could result in cost savings for hospital systems while maintaining adequate patient comfort and satisfaction.
Primary outcome:
Secondary outcomes:
Methods:
Patients scheduled to undergo minimally invasive benign gynecologic surgery will be randomized to one of two groups:
Group 1: acetaminophen 1 gram PO 30min before surgery, then saline placebo IV after anesthesia induction but before skin incision
Group 2: receives placebo pill PO 30min before surgery, then acetaminophen 1 gram IV after anesthesia induction but before skin incision
Primary outcome: After surgery, postoperative pain measured at various time points by blinded investigator
2 hours postop, 4 hours postop, 24 hours postop
Secondary outcomes:
Demographics to collect:
Age, parity, BMI, procedure indication, pathology including uterine weight, procedure length
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Acetominophen Arm | Experimental | 1000 mg acetominophen oral |
|
| Intravenous | Active Comparator | 1000 mg acetominophen intravenous |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acetominophen | Drug | INTRAVENOUS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain - VAS | Pain level 2 hours post treatment | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pain - VAS | Pain level 4 hours post treatment | 4 hours |
| Pain - VAS | Pain level 24 hours post treatment | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Kahn, MD | Scripps | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Clinic | San Diego | California | 92130 | United States | ||
| Scripps Clininc Dept of Ob/Gyn |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31764741 | Derived | Lombardi TM, Kahn BS, Tsai LJ, Waalen JM, Wachi N. Preemptive Oral Compared With Intravenous Acetaminophen for Postoperative Pain After Robotic-Assisted Laparoscopic Hysterectomy: A Randomized Controlled Trial. Obstet Gynecol. 2019 Dec;134(6):1293-1297. doi: 10.1097/AOG.0000000000003578. |
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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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| Acetaminophen | Drug | ORAL |
|
|
| San Diego |
| California |
| 92130 |
| United States |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |