- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04149964
Postoperative Pain Control in Septum and Sinus Surgery
Postoperative Pain Control in Septum and Sinus Surgery: A Novel Approach.
Study Overview
Status
Conditions
Detailed Description
Pain control in the postoperative period following septum and/or sinus surgery is controversial, as there is no consensus statement regarding current guidelines to direct clinical practice. Recent legislation limits opioid prescription length to 5 days only, which brings into question whether legislation will affect prescribing practices of physicians and whether or not giving patients an alternative to opiates will be a more efficacious route.
Current prescribing practices for septum and sinus surgery of the Otolaryngology private practice group includes as-needed acetaminophen 325 mg and as-needed acetaminophen/hydrocodone 7.5 mg/325 mg. If it can be demonstrated that use of 650 mg acetaminophen in scheduled doses of every 6 hours can decrease postoperative opiate use in the first week without significantly increase in patient pain, this may be deployed as an effective strategy of pain control as the use of opiates has come under scrutiny and attempts are being made to decrease or limit the use of these medications in the medical setting.
This study would look to demonstrate that scheduled doses of acetaminophen as opposed to reactionary as-needed acetaminophen can control post-operative pain to the point where narcotics would not be necessary.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Michigan
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Farmington Hills, Michigan, United States, 48336
- Beaumont Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Undergoing primary sinus surgery, primary septum surgery, or primary sinus/septum surgery
- 18 years of age or older
- Male or female
- No known allergies to or contraindications to the use of acetaminophen, hydrocodone, or oxycodone
- Patients discharged to home after surgery
Exclusion Criteria:
- Undergoing revision sinus, septum, or sinus/septum surgery
- Younger than 18 years old
- Allergy or contraindication to acetaminophen, hydrocodone, or oxycodone
- Patients admitted to the hospital postoperatively for airway monitoring
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard of Care arm
Standard of Care Post-operative pain medication, Acetaminophen 325 mg every 6 hours as needed for pain plus acetaminophen/hydrocodone 7.5 mg/325 mg 1 tab every 4 hours as needed for pain.
|
Standard of Care Acetaminophen 325 mg every 6 hours as needed for pain
Other Names:
Acetaminophen 325 mg/ Hydrocodone 7.5 mg oral tablet every 4 hours as needed for breakthrough pain
Other Names:
|
Experimental: Study Arm
Acetaminophen 650 mg 1 tab every 6 hours round the clock plus Oxycodone 5 mg 1 tab every 6 hours as needed for breakthrough pain,.
|
Acetaminophen 650 mg scheduled every 6 hours round the clock for pain
Other Names:
Oxycodone 5 mg every 4 hours as needed for breakthrough pain
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Doses of Opiate (Narcotic) Pain Medication
Time Frame: 7 days
|
Number of doses of opiates (narcotic) pain medication participants took for breakthrough pain in the first postoperative week.
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Highest Subjective Pain Score
Time Frame: 7 days
|
Highest post-operative pain score during the first postoperative week as measured on an 11-point numeric pain scale from 0-10, with 0 = no pain and 10 = worst pain possible.
|
7 days
|
Lowest Subjective Pain Score
Time Frame: 7 days
|
Lowest post-operative pain score during the first postoperative week as measured on an 11 point numeric pain scale from 0-10, with 0 = no pain and 10 = worst pain possible.
|
7 days
|
Percentage of Time Participant Experienced Severe Pain
Time Frame: 7 days
|
Percentage of time participant experienced severe pain requiring breakthrough pain medication during the first postoperative week, as measured on an 11 point numeric scale, from 0% to 100%, where 0% means never in severe pain and 100% means always in severe pain.
|
7 days
|
Participant Use of Acetaminophen as Needed
Time Frame: 7 days
|
Number of participants who took acetaminophen as needed during the first postoperative week.
|
7 days
|
Participant Use of Scheduled Acetaminophen Around the Clock
Time Frame: 7 days
|
Number of participants who took acetaminophen every 6 hours around the clock during first postoperative week.
|
7 days
|
Chronic Use of Pain Medication
Time Frame: 7 days
|
Number of participants who answered "Yes" to the survey question, "Do you take pain medication, including narcotics, for any other medical condition?"
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7 days
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Participant Use of Additional Pain Medication
Time Frame: 7 days
|
Number of participants who took other pain medication (over-the-counter or narcotic) in addition to study-prescribed pain medications during first postoperative week.
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7 days
|
Types of Other Pain Medication Used
Time Frame: 7 days
|
Self-reported name of pain medication (over-the-counter or narcotic) used by participants in addition to study-prescribed pain medications during the first postoperative week
|
7 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Seel, DO., William Beaumont Hospital - Farmington Hills
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antipyretics
- Analgesics, Opioid
- Narcotics
- Respiratory System Agents
- Antitussive Agents
- Acetaminophen
- Oxycodone
- Hydrocodone
- Acetaminophen, hydrocodone drug combination
Other Study ID Numbers
- 2019-259
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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