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Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors

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ClinicalTrials.gov Identifier: NCT02351700
Recruitment Status : Completed
First Posted : January 30, 2015
Last Update Posted : April 14, 2017
Sponsor:
Information provided by (Responsible Party):
St. Joseph's Hospital and Medical Center, Phoenix

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.

Condition or disease Intervention/treatment Phase
Pituitary Tumor Pain Drug: IV Caldolor (IV Ibuprofen) Drug: IV Ibuprofen placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Randomized, Double-Blind, Placebo-Controlled Trial Comparing Opioid-Sparing and Opioid-Containing Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors
Actual Study Start Date : February 1, 2015
Actual Primary Completion Date : March 1, 2016
Actual Study Completion Date : April 1, 2016


Arm Intervention/treatment
Active Comparator: opioid-sparing group
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.
Drug: IV Caldolor (IV Ibuprofen)
Compare addition of IV Caldolor (IV ibuprofen) intraoperatively and postoperatively against IV ibuprofen placebo added intraoperatively and postoperatively.
Other Name: Caldolor

Placebo Comparator: standard treatment group
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.
Drug: IV Ibuprofen placebo
Compare addition of IV ibuprofen placebo intraoperatively and postoperatively against IV Caldolor (IV ibuprofen) added intraoperatively and postoperatively.
Other Name: Caldolor placebo




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. Total cost of hospital charges compared between two arms [ Time Frame: until discharge from hospital, an expected stay of 2 days ]
  6. 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

  7. Cost of pharmacy charges compared between two arms [ Time Frame: until discharge from hospital, an expected stay of 2 days ]
  8. Length of stay in hospital compared between two arms [ Time Frame: until discharge from hospital, an expected stay of 2 days ]


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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02351700


Locations
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United States, Arizona
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
Sponsors and Collaborators
St. Joseph's Hospital and Medical Center, Phoenix
Investigators
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Principal Investigator: Andrew S Little, MD Barrow Neurosurgical Associates physician with SJHMC privileges

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier: NCT02351700     History of Changes
Other Study ID Numbers: 14BN090
First Posted: January 30, 2015    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
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Pituitary Diseases
Pituitary Neoplasms
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action