A randomized, double-blind, placebo-controlled intervention trial involving 100 treated
subjects undergoing endonasal trans-sphenoidal (ENTS) resection of pituitary lesion.
Subjects will be randomized into two groups: 50 treated in the opioid-sparing arm and 50
treated in the standard post-operative medication arm.
Post-operative pain control is a common concern patients have when they consider undergoing
a surgical procedure. Although effective for treating acute pain, opioid analgesics are also
associated with dose-dependent adverse effects, including constipation, nausea and vomiting,
altered mental status, and respiratory depression, all of which have been shown to increase
patient length of stay. The use of non-opioid analgesics with different mechanisms of
actions for acute pain control via a multi-modal approach is efficacious in reducing opioid
consumption, decreasing the incidence of adverse effects, improving patient satisfaction and
recovery time, and decreasing hospital costs.Certain minimally invasive procedures may
afford many patients the opportunity to achieve adequate post-operative pain control with
minimal to no requirement of opioid analgesics, thereby sparing the patient known adverse
effects that can increase length of stay and costs. The ENTS approach for resection of
pituitary tumors is the standard surgical procedure for these lesions, and is associated
with pain that is more easily managed post-operatively, making it an ideal procedure for an
opioid-sparing post-operative pain regimen. Anecdotally, the investigators note that in the
investigator's post-operative pituitary patient population that post-operative pain can
frequently be adequately managed with scheduled non-opioid analgesics, often without
requiring breakthrough opioid doses. Another safe and effective non-opioid analgesic that is
widely used in multi-modal pain management for moderate pain is IV Caldolor (ibuprofen).
After literature review, the investigators were unable to find a study that had attempted to
use an opioid-sparing analgesic regimen for post-operative pain control following ENTS
approach for resection of pituitary tumors.
- Adult patient undergoing ENTS surgery for resection of pituitary tumor.
- Adults >18 years and <80 years of age.
- English speaking and literate or able to understand the use of a pain scale.
- Body Mass Index >19 and <40 kg/m2
- Renal failure (acute or chronic) or creatinine >2.0
- Allergy or intolerance to acetaminophen, ibuprofen, or opioids
- Pre-operative opioid tolerance, dependence, or abuse
- Anaphylaxis to opioids
- History of peptic ulcer disease or recent gastrointestinal bleed requiring surgery
- Cirrhosis, hepatitis, liver transplant, or liver function studies out of normal
range, defined as aspartate aminotransferase (AST)/alanine aminotransferase
(ALT)/bilirubin> 3x upper limit of normal range
- Subject unwilling or unable to sign informed consent for the study
- Incarcerated patients