Clinical trial NCT02351700: Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors
Official title: Randomized, Double-Blind, Placebo-Controlled Trial Comparing Opioid-Sparing and Opioid-Containing Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pituitary Tumor
Pain
Lead sponsor: St. Joseph's Hospital and Medical Center, Phoenix
Sponsor class: OTHER
First posted: 2015-01-30
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of Mean Pain Scores Between Two Arms (Measured Every 4 Hours Over 48 Hour)
timeFrame: mean pain score over 48 hours
Secondary outcomes:
measure: Breakthrough Narcotic Requirement
timeFrame: until discharge from hospital, an expected stay of 2 days
measure: Other Adverse Events
timeFrame: until discharge from hospital, an expected stay of 2 days
Other outcomes:
measure: Total Cost of Hospital Charges Compared Between Two Arms
timeFrame: until discharge from hospital, an expected stay of 2 days
measure: The Number of Participants Who Have a Bowel Movement During Hospitalization in Both Groups
timeFrame: until discharge from hospital, an expected stay of 2 days
measure: Length of Stay in Hospital Compared Between Two Arms
timeFrame: until discharge from hospital, an expected stay of 2 days
measure: Total Number of Doses of Any Anti-emetic Required Post-operatively in Both Groups
timeFrame: until discharge from hospital, an expected stay of 2 days
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
Study officials:
affiliation: Barrow Neurosurgical Associates physician with SJHMC privileges
name: Andrew S Little, MD
role: PRINCIPAL_INVESTIGATOR
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citation: Shepherd DM, Jahnke H, White WL, Little AS. Randomized, double-blinded, placebo-controlled trial comparing two multimodal opioid-minimizing pain management regimens following transsphenoidal surgery. J Neurosurg. 2018 Feb;128(2):444-451. doi: 10.3171/2016.10.JNS161355. Epub 2017 Mar 3.