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Postoperative Pain Control in Septum and Sinus Surgery

Primary Purpose

Post-operative Pain, Sinus Surgery

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Acetaminophen 325 mg Oral Tablet
Acetaminophen 650 mg Oral Tablet
OxyCODONE 5 mg Oral Tablet
Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet
Sponsored by
William Beaumont Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Pain focused on measuring Post-operative pain, Sinus pain, Sinus surgery, Septum Pain, deviated septum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beaumont Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care arm

Study Arm

Arm Description

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.

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,.

Outcomes

Primary Outcome Measures

Number of Doses of Opiate (Narcotic) Pain Medication
Number of doses of opiates (narcotic) pain medication participants took for breakthrough pain in the first postoperative week.

Secondary Outcome Measures

Highest Subjective Pain Score
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.
Lowest Subjective Pain Score
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.
Percentage of Time Participant Experienced Severe Pain
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.
Participant Use of Acetaminophen as Needed
Number of participants who took acetaminophen as needed during the first postoperative week.
Participant Use of Scheduled Acetaminophen Around the Clock
Number of participants who took acetaminophen every 6 hours around the clock during first postoperative week.
Chronic Use of Pain Medication
Number of participants who answered "Yes" to the survey question, "Do you take pain medication, including narcotics, for any other medical condition?"
Participant Use of Additional Pain Medication
Number of participants who took other pain medication (over-the-counter or narcotic) in addition to study-prescribed pain medications during first postoperative week.
Types of Other Pain Medication Used
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

Full Information

First Posted
October 30, 2019
Last Updated
August 9, 2023
Sponsor
William Beaumont Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT04149964
Brief Title
Postoperative Pain Control in Septum and Sinus Surgery
Official Title
Postoperative Pain Control in Septum and Sinus Surgery: A Novel Approach.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 27, 2019 (Actual)
Primary Completion Date
September 21, 2022 (Actual)
Study Completion Date
September 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
William Beaumont Hospitals

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain, Sinus Surgery
Keywords
Post-operative pain, Sinus pain, Sinus surgery, Septum Pain, deviated septum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Study Arm
Arm Type
Experimental
Arm Description
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,.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen 325 mg Oral Tablet
Other Intervention Name(s)
Tylenol Standard Strength
Intervention Description
Standard of Care Acetaminophen 325 mg every 6 hours as needed for pain
Intervention Type
Drug
Intervention Name(s)
Acetaminophen 650 mg Oral Tablet
Other Intervention Name(s)
Tylenol Extra Strength
Intervention Description
Acetaminophen 650 mg scheduled every 6 hours round the clock for pain
Intervention Type
Drug
Intervention Name(s)
OxyCODONE 5 mg Oral Tablet
Other Intervention Name(s)
Percodan, Percocet
Intervention Description
Oxycodone 5 mg every 4 hours as needed for breakthrough pain
Intervention Type
Drug
Intervention Name(s)
Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet
Other Intervention Name(s)
Norco
Intervention Description
Acetaminophen 325 mg/ Hydrocodone 7.5 mg oral tablet every 4 hours as needed for breakthrough pain
Primary Outcome Measure Information:
Title
Number of Doses of Opiate (Narcotic) Pain Medication
Description
Number of doses of opiates (narcotic) pain medication participants took for breakthrough pain in the first postoperative week.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Highest Subjective Pain Score
Description
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.
Time Frame
7 days
Title
Lowest Subjective Pain Score
Description
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.
Time Frame
7 days
Title
Percentage of Time Participant Experienced Severe Pain
Description
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.
Time Frame
7 days
Title
Participant Use of Acetaminophen as Needed
Description
Number of participants who took acetaminophen as needed during the first postoperative week.
Time Frame
7 days
Title
Participant Use of Scheduled Acetaminophen Around the Clock
Description
Number of participants who took acetaminophen every 6 hours around the clock during first postoperative week.
Time Frame
7 days
Title
Chronic Use of Pain Medication
Description
Number of participants who answered "Yes" to the survey question, "Do you take pain medication, including narcotics, for any other medical condition?"
Time Frame
7 days
Title
Participant Use of Additional Pain Medication
Description
Number of participants who took other pain medication (over-the-counter or narcotic) in addition to study-prescribed pain medications during first postoperative week.
Time Frame
7 days
Title
Types of Other Pain Medication Used
Description
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
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Seel, DO.
Organizational Affiliation
William Beaumont Hospital - Farmington Hills
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beaumont Hospital
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48336
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Postoperative Pain Control in Septum and Sinus Surgery

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