Overview

This trial is active, not recruiting.

Conditions pituitary tumor, pain
Treatments iv caldolor (iv ibuprofen), iv ibuprofen placebo
Phase phase 4
Sponsor St. Joseph's Hospital and Medical Center, Phoenix
Start date February 2015
End date December 2016
Trial size 62 participants
Trial identifier NCT02351700, 14BN090

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose supportive care
Arm
(Active Comparator)
Intravenous (IV) Caldolor (ibuprofen) (800mg every 8 hours) initiated during surgery and oral acetaminophen 1000mg every 6 hours initiated post-operatively and continued for the duration of the hospital stay (an expected average stay of 2 days) or 48 hours, whichever comes first. Breakthrough pain will be treated with rescue narcotics (IV morphine 2-4mg every 2 hours and oral oxycodone 5-15mg every 4 hours immediately post-operatively through discharge, an expected average stay of 2 days). Hydromorphone (IV 0.5-2mg every 2 hours and oral 2-4mg every 4 hours) will be used in patients with morphine or oxycodone allergy or intolerance.
iv caldolor (iv ibuprofen) Caldolor
Compare addition of IV Caldolor (IV ibuprofen) intraoperatively and postoperatively against IV ibuprofen placebo added intraoperatively and postoperatively.
(Placebo Comparator)
IV Caldolor placebo will be initiated during surgery and oral acetaminophen 1000mg every 6 hours will be initiated post-operatively and continued for the duration of the hospital stay (an expected average stay of 2 days) or 48 hours, whichever comes first. Breakthrough pain will be treated with rescue narcotics (IV morphine 2-4mg every 2 hours and oral oxycodone 5-15mg every 4 hours immediately post-operatively through discharge, an expected average stay of 2 days). Hydromorphone (IV 0.5-2mg every 2 hours and oral 2-4mg every 4 hours) will be used in patients with morphine or oxycodone allergy or intolerance.
iv ibuprofen placebo Caldolor placebo
Compare addition of IV ibuprofen placebo intraoperatively and postoperatively against IV Caldolor (IV ibuprofen) added intraoperatively and postoperatively.

Primary Outcomes

Measure
Comparison of pain scores between two arms
time frame: 4 hour intervals for 48 hours or until discharge from hospital (an expected stay of 2 days), whichever comes first

Secondary Outcomes

Measure
Breakthrough narcotic requirement
time frame: until discharge from hospital, an expected stay of 2 days
Total number of doses and type of any anti-emetic required post-operatively in both groups
time frame: until discharge from hospital, an expected stay of 2 days
The number of patients who do not have a bowel movement during hospitalization in both groups
time frame: until discharge from hospital, an expected stay of 2 days
The number of patients in both groups with opioid-associated adverse events, such as respiratory depression or sedation, using Pasero Opioid-Induced Sedation Scale (POSS)
time frame: until discharge from hospital, an expected stay of 2 days
Total cost of hospital charges compared between two arms
time frame: until discharge from hospital, an expected stay of 2 days
Other adverse events
time frame: until discharge from hospital, an expected stay of 2 days
Cost of pharmacy charges compared between two arms
time frame: until discharge from hospital, an expected stay of 2 days
Length of stay in hospital compared between two arms
time frame: until discharge from hospital, an expected stay of 2 days

Eligibility Criteria

Male or female participants from 18 years up to 79 years old.

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

Additional Information

Official title Randomized, Double-Blind, Placebo-Controlled Trial Comparing Opioid-Sparing and Opioid-Containing Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors
Principal investigator Andrew S Little, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by St. Joseph's Hospital and Medical Center, Phoenix.