Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Joseph's Hospital and Medical Center, Phoenix
• Treatments: Ibuprofen

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