Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors
Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors
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.
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  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

 -  Pregnancy

 -  Incarcerated patients