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Postoperative Pain Control in Septum and Sinus Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04149964
Recruitment Status : Recruiting
First Posted : November 4, 2019
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
David Seel, William Beaumont Hospitals

Brief Summary:
This study will evaluate if the use of acetaminophen round the clock (scheduled doses) will lead to less opiate use in the first week post-operative (after surgery) in sinus/septum surgery patients. Participants will be randomized like a flip of a coin to either the standard of care pain treatment of acetaminophen 325 mg as needed for pain plus opiates (acetaminophen/hydrocodone) as needed for breakthrough pain; OR to the study arm of acetaminophen 650 mg every 6 hours plus opiates (Oxycodone)as needed for breakthrough pain.

Condition or disease Intervention/treatment Phase
Post-operative Pain Sinus Surgery Drug: Acetaminophen 325 mg Oral Tablet Drug: Acetaminophen 650 mg Oral Tablet Drug: OxyCODONE 5 mg Oral Tablet Drug: Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open, randomized into one of two arms study. Study arm 1: Standard of care arm of Acetaminophen (Tylenol) 325 mg every 6 hours as needed plus acetaminophen/hydrocodone 7.5 mg/325mg every 4 hours for breakthrough pain. Study arm 2: Acetaminophen 650 mg. every 6 hours round the clock plus 5 mg oxycodone every 4 hours as needed for breakthrough pain.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Postoperative Pain Control in Septum and Sinus Surgery: A Novel Approach.
Actual Study Start Date : November 27, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine


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.
Drug: Acetaminophen 325 mg Oral Tablet
Standard of Care Acetaminophen 325 mg every 6 hours as needed for pain
Other Name: Tylenol Standard Strength

Drug: Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet
Acetaminophen 325 mg/ Hydrocodone 7.5 mg oral tablet every 4 hours as needed for breakthrough pain
Other Name: Norco

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,.
Drug: Acetaminophen 650 mg Oral Tablet
Acetaminophen 650 mg scheduled every 6 hours round the clock for pain
Other Name: Tylenol Extra Strength

Drug: OxyCODONE 5 mg Oral Tablet
Oxycodone 5 mg every 4 hours as needed for breakthrough pain
Other Name: Percodan, Percocet




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Participant use of acetaminophen as needed [ Time Frame: 7 days ]
    Number of participants who took acetaminophen as needed during the first postoperative week.

  5. 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.

  6. 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?"

  7. 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.

  8. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04149964


Contacts
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Contact: Eric Cox, DO. 616 340 2499 eric.cox@beaumont.org
Contact: Evie Russell, RN. 248-471-8136 Evelyne.Russell@beaumont.org

Locations
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United States, Michigan
Beaumont Hospital Recruiting
Farmington Hills, Michigan, United States, 48336
Contact: Evie Russell, RN.    248-471-8136    evie.russell@beaumont.org   
Contact: Mariquit Sendelbach, DO    248 579 9220    mariquit.sendelbach@beaumont.org   
Sponsors and Collaborators
William Beaumont Hospitals
Investigators
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Principal Investigator: David Seel, DO. William Beaumont Hospital - Farmington Hills

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Responsible Party: David Seel, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT04149964    
Other Study ID Numbers: 2019-259
First Posted: November 4, 2019    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by David Seel, William Beaumont Hospitals:
Post-operative pain
Sinus pain
Sinus surgery
Septum Pain
deviated septum
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Acetaminophen, hydrocodone drug combination
Oxycodone
Hydrocodone
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents