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NCT Number: NCT02351700

Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IV Caldolor

Drug

IV Caldolor (IV ibuprofen) intraoperatively and postoperatively

Other names: IV ibuprofen, Opioid Sparing group

IV Placebo

Drug

IV Placebo intraoperatively and postoperatively

Other names: Standard treatment group

Primary outcomes

  1. Comparison of Mean Pain Scores Between Two Arms (Measured Every 4 Hours Over 48 Hour)

    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.

Secondary outcomes

  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. 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

Other outcomes

  1. Total Cost of Hospital Charges Compared Between Two Arms

    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

  2. The Number of Participants Who Have a Bowel Movement During Hospitalization in Both Groups

    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

  3. Length of Stay in Hospital Compared Between Two Arms

    Time frame: until discharge from hospital, an expected stay of 2 days

    Length of hospital stay from time of surgery to time of discharge.

  4. Total Number of Doses of Any Anti-emetic Required Post-operatively in Both Groups

    Time frame: until discharge from hospital, an expected stay of 2 days

    Use of antiemetics in first 48 hours after surgery

Sponsors and collaborators

Lead sponsor

St. Joseph's Hospital and Medical Center, Phoenix

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 30, 2015
Registry last updated
Oct 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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