St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
NCT Number: NCT02351700
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.
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Notify Me18 year–79 year
All sexes
Interventional
Phase 4
Phoenix, Arizona, 85013, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
IV Caldolor (IV ibuprofen) intraoperatively and postoperatively
Other names: IV ibuprofen, Opioid Sparing group
IV Placebo intraoperatively and postoperatively
Other names: Standard treatment group
Time frame: mean pain score over 48 hours
Comparison of pain scores between two arms using Visual Analog Scale (VAS) for Pain. Units of measure are 0=No Pain, 1=Annoying, 2=Mild Pain, 3=Troublesome, 4=Nagging Pain, Uncomfortable, 5=Distressing, 6=Miserable, 7=Horrible, 8=Intense, Dreadful, 9=Unbearable, 10=Worst Possible Pain. Higher values represent a worse outcome. There are no subscales.
Time frame: until discharge from hospital, an expected stay of 2 days
Rescue narcotic in both groups will be recorded and compared using a standard equianalgesic oral morphine equivalent (OME) calculation
Time frame: until discharge from hospital, an expected stay of 2 days
Epistaxis, potentially related to IV ibuprofen, will be compared between two groups
Time frame: until discharge from hospital, an expected stay of 2 days
Total hospital costs for patients in IV ibuprofen arm compared to IV placebo arm
Time frame: until discharge from hospital, an expected stay of 2 days
patients with one or more bowel movement(s) in the first 48 hours after surgery
Time frame: until discharge from hospital, an expected stay of 2 days
Length of hospital stay from time of surgery to time of discharge.
Time frame: until discharge from hospital, an expected stay of 2 days
Use of antiemetics in first 48 hours after surgery
St. Joseph's Hospital and Medical Center, Phoenix
Other
Randomized, Double-Blind, Placebo-Controlled Trial Comparing Opioid-Sparing and Opioid-Containing Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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