An interventional study of acetominophen and Acetaminophen in Post-operative Pain, sponsored by Scripps Health. Completed at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-22.
Sponsored by Scripps Health · Not applicable, Interventional, and Treatment
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:
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
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
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's enrollment of 75 is close to the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Scripps Health is the lead sponsor of 48 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1000 mg acetominophen oral
Drug: acetominophen · Drug: Acetaminophen
1000 mg acetominophen intravenous
Drug: acetominophen · Drug: Acetaminophen
INTRAVENOUS
Also known as: Ofirmev
ORAL
Also known as: Tylenol
Pain - VAS
Pain level 2 hours post treatment
Time frame: 2 hours
Pain - VAS
Pain level 4 hours post treatment
Time frame: 4 hours
Pain - VAS
Pain level 24 hours post treatment
Time frame: 24 hours
Ran from Feb 2016 to primary completion in Feb 2018, 24 months.
Of 2,089 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 24 months is above that.
Counting every sponsor, half of 2,102 studies reached it within 11 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Acetaminophen
Scripps Health