Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors

NCT ID: NCT02351700

Last Updated: 2021-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-01
• Study Completion Date: 2016-04-01

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.

Conditions

Pituitary Tumor; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

IV Caldolor (ibuprofen)

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.

Group Type: ACTIVE_COMPARATOR

IV Caldolor

Intervention Type: DRUG

IV Caldolor (IV ibuprofen) intraoperatively and postoperatively

standard treatment group

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.

Group Type: PLACEBO_COMPARATOR

IV Placebo

Intervention Type: DRUG

IV Placebo intraoperatively and postoperatively

Interventions

IV Caldolor

IV Caldolor (IV ibuprofen) intraoperatively and postoperatively

Intervention Type: DRUG

IV Placebo

IV Placebo intraoperatively and postoperatively

Intervention Type: DRUG

Other Intervention Names

IV ibuprofen; Opioid Sparing group; Standard treatment group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Joseph's Hospital and Medical Center, Phoenix

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew S Little, MD

Role: PRINCIPAL_INVESTIGATOR

Barrow Neurosurgical Associates physician with SJHMC privileges

Locations

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Reference Type: RESULT

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

14BN090

Identifier Type: -

Identifier Source: org_study_id