Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain, Brain Cancer |
| Therapuetic Areas: | Musculoskeletal, Oncology |
| Healthy: | No |
| Age Range: | 18 - 79 |
| Updated: | 10/14/2017 |
| Start Date: | February 1, 2015 |
| End Date: | April 1, 2016 |
Randomized, Double-Blind, Placebo-Controlled Trial Comparing Opioid-Sparing and Opioid-Containing 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.
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.
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.
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.
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
We found this trial at
1
site
350 W Thomas Rd
Phoenix, Arizona 85013
Phoenix, Arizona 85013
(602) 406-3000
Phone: 602-406-6976
St. Joseph's Hospital and Medical Center St. Joseph's is a nationally recognized center for quality...
Click here to add this to my saved trials
