Clinical Trial: Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized, Double-Blind, Placebo-Controlled Trial Comparing Opioid-Sparing and Opioid-Containing Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors

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 Summary: 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.
Sponsor: St. Joseph's Hospital and Medical Center, Phoenix

Current Primary Outcome: 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 ]

Visual Analog Scale for Pain


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Breakthrough narcotic requirement [ 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
  • 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 ]
    Epistaxis, potentially related to IV ibuprofen, will be compared between two groups
  • 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 ]


Original Secondary Outcome: Same as current

Information By: St. Joseph's Hospital and Medical Center, Phoenix

Dates:
Date Received: January 14, 2015
Date Started: February 1, 2015
Date Completion:
Last Updated: April 12, 2017
Last Verified: April 2017