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NCT02351700 · REGISTRY CONDITION SEARCH

Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE4
Status at capture
COMPLETED
Registry last update
2021-10-21

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

Breakthrough Narcotic Requirement

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outcome · POSTED

Other Adverse Events

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outcome · NOT POSTED

Total Cost of Hospital Charges Compared Between Two Arms

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outcome · POSTED

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

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outcome · POSTED

Length of Stay in Hospital Compared Between Two Arms

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outcome · POSTED

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

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility 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
healthy Volunteers
false
maximum Age
79 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Drug: IV Caldolor
    label
    IV Caldolor (ibuprofen)
    type
    ACTIVE_COMPARATOR
  2. description
    IV 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.
    intervention Names
    1. Drug: IV Placebo
    label
    standard treatment group
    type
    PLACEBO_COMPARATOR
interventions
  1. arm Group Labels
    1. IV Caldolor (ibuprofen)
    description
    IV Caldolor (IV ibuprofen) intraoperatively and postoperatively
    name
    IV Caldolor
    other Names
    1. IV ibuprofen
    2. Opioid Sparing group
    type
    DRUG
  2. arm Group Labels
    1. standard treatment group
    description
    IV Placebo intraoperatively and postoperatively
    name
    IV Placebo
    other Names
    1. Standard treatment group
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
DOUBLE
who Masked
  1. PARTICIPANT
  2. INVESTIGATOR
primary Purpose
SUPPORTIVE_CARE
Enrollment
count
62
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. description
    Total hospital costs for patients in IV ibuprofen arm compared to IV placebo arm
    measure
    Total Cost of Hospital Charges Compared Between Two Arms
    time Frame
    until discharge from hospital, an expected stay of 2 days
  2. description
    patients with one or more bowel movement(s) in the first 48 hours after surgery
    measure
    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
  3. description
    Length of hospital stay from time of surgery to time of discharge.
    measure
    Length of Stay in Hospital Compared Between Two Arms
    time Frame
    until discharge from hospital, an expected stay of 2 days
  4. description
    Use of antiemetics in first 48 hours after surgery
    measure
    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
primary Outcomes
  1. description
    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.
    measure
    Comparison of Mean Pain Scores Between Two Arms (Measured Every 4 Hours Over 48 Hour)
    time Frame
    mean pain score over 48 hours
secondary Outcomes
  1. description
    Rescue narcotic in both groups will be recorded and compared using a standard equianalgesic oral morphine equivalent (OME) calculation
    measure
    Breakthrough Narcotic Requirement
    time Frame
    until discharge from hospital, an expected stay of 2 days
  2. description
    Epistaxis, potentially related to IV ibuprofen, will be compared between two groups
    measure
    Other Adverse Events
    time Frame
    until discharge from hospital, an expected stay of 2 days
Full study description
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 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.
Source references
references
  1. citation
    Pizzi LT, Toner R, Foley K, Thomson E, Chow W, Kim M, Couto J, Royo M, Viscusi E. Relationship between potential opioid-related adverse effects and hospital length of stay in patients receiving opioids after orthopedic surgery. Pharmacotherapy. 2012 Jun;32(6):502-14. doi: 10.1002/j.1875-9114.2012.01101.x. Epub 2012 May 8.
    pmid
    22570188
    type
    BACKGROUND
  2. citation
    Husted H. Fast-track hip and knee arthroplasty: clinical and organizational aspects. Acta Orthop Suppl. 2012 Oct;83(346):1-39. doi: 10.3109/17453674.2012.700593.
    pmid
    23205862
    type
    BACKGROUND
  3. citation
    Costantini R, Affaitati G, Fabrizio A, Giamberardino MA. Controlling pain in the post-operative setting. Int J Clin Pharmacol Ther. 2011 Feb;49(2):116-27. doi: 10.5414/cp201401.
    pmid
    21255528
    type
    BACKGROUND
  4. citation
    Badie B, Nguyen P, Preston JK. Endoscopic-guided direct endonasal approach for pituitary surgery. Surg Neurol. 2000 Feb;53(2):168-72; discussion 172-3. doi: 10.1016/s0090-3019(99)00195-0.
    pmid
    10713196
    type
    BACKGROUND
  5. citation
    Dahl V, Dybvik T, Steen T, Aune AK, Rosenlund EK, Raeder JC. Ibuprofen vs. acetaminophen vs. ibuprofen and acetaminophen after arthroscopically assisted anterior cruciate ligament reconstruction. Eur J Anaesthesiol. 2004 Jun;21(6):471-5. doi: 10.1017/s026502150400609x.
    pmid
    15248627
    type
    BACKGROUND
  6. citation
    Southworth S, Peters J, Rock A, Pavliv L. A multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen 400 and 800 mg every 6 hours in the management of postoperative pain. Clin Ther. 2009 Sep;31(9):1922-35. doi: 10.1016/j.clinthera.2009.08.026.
    pmid
    19843482
    type
    BACKGROUND
  7. citation
    Singla N, Rock A, Pavliv L. A multi-center, randomized, double-blind placebo-controlled trial of intravenous-ibuprofen (IV-ibuprofen) for treatment of pain in post-operative orthopedic adult patients. Pain Med. 2010 Aug;11(8):1284-93. doi: 10.1111/j.1526-4637.2010.00896.x. Epub 2010 Jun 30.
    pmid
    20609131
    type
    BACKGROUND
  8. citation
    Kroll PB, Meadows L, Rock A, Pavliv L. A multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen (i.v.-ibuprofen) in the management of postoperative pain following abdominal hysterectomy. Pain Pract. 2011 Jan-Feb;11(1):23-32. doi: 10.1111/j.1533-2500.2010.00402.x.
    pmid
    20642488
    type
    BACKGROUND
  9. citation
    Chung KC, Barlev A, Braun AH, Qian Y, Zagari M. Assessing analgesic use in patients with advanced cancer: development of a new scale--the Analgesic Quantification Algorithm. Pain Med. 2014 Feb;15(2):225-32. doi: 10.1111/pme.12299. Epub 2014 Jan 8.
    pmid
    24400921
    type
    BACKGROUND
  10. citation
    Shepherd DM, Jahnke H, White WL, Little AS. Randomized, double-blinded, placebo-controlled trial comparing two multimodal opioid-minimizing pain management regimens following transsphenoidal surgery. J Neurosurg. 2018 Feb;128(2):444-451. doi: 10.3171/2016.10.JNS161355. Epub 2017 Mar 3.
    pmid
    28298041
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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      query disease state id
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    Preserved source evidence · Not medical advice