Post-operative PainPhase 4NCT04149964
Postoperative Pain Control in Septum and Sinus Surgery
A Phase 4 study testing Acetaminophen 325 mg Oral Tablet, Acetaminophen 650 mg Oral Tablet and OxyCODONE 5 mg Oral Tablet in people with Post-operative Pain and Sinus Surgery, run by Corewell Health East at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-operative Pain, Sinus Surgery
- What is being tested?
- Acetaminophen 325 mg Oral Tablet, Acetaminophen 650 mg Oral Tablet and OxyCODONE 5 mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2019to 21 Sep 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Pain Control in Septum and Sinus Surgery: A Novel Approach.
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.
Read the 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.
- Conditions
- Post-operative Pain, Sinus Surgery
- Being tested
- Acetaminophen 325 mg Oral Tablet, Acetaminophen 650 mg Oral Tablet, OxyCODONE 5 mg Oral Tablet, Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet
- Keywords
- Post-operative pain, Sinus pain, Sinus surgery, Septum Pain, deviated septum
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetaminophen 325 mg Oral TabletDrug
Also called Tylenol Standard Strength
Standard of Care Acetaminophen 325 mg every 6 hours as needed for pain
Acetaminophen 650 mg Oral TabletDrug
Also called Tylenol Extra Strength
Acetaminophen 650 mg scheduled every 6 hours round the clock for pain
OxyCODONE 5 mg Oral TabletDrug
Also called Percodan, Percocet
Oxycodone 5 mg every 4 hours as needed for breakthrough pain
Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tabletDrug
Also called Norco
Acetaminophen 325 mg/ Hydrocodone 7.5 mg oral tablet every 4 hours as needed for breakthrough pain
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care arm | Active comparator | 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. Receives: Drug: Acetaminophen 325 mg Oral Tablet; Drug: Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet |
| Study Arm | Experimental | 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,. Receives: Drug: Acetaminophen 650 mg Oral Tablet; Drug: OxyCODONE 5 mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (8)
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.
Measured: 7 days
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.
Measured: 7 days
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.
Measured: 7 days
Participant Use of Acetaminophen as Needed
Number of participants who took acetaminophen as needed during the first postoperative week.
Measured: 7 days
Participant Use of Scheduled Acetaminophen Around the Clock
Number of participants who took acetaminophen every 6 hours around the clock during first postoperative week.
Measured: 7 days
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?"
Measured: 7 days
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.
Measured: 7 days
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
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start27 Nov 2019
- Primary completion21 Sep 2022
- Study completion21 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Seel, Corewell Health East
- Investigators
- David Seel, DO., Principal investigator, William Beaumont Hospital - Farmington Hills
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149964
- Sponsor's protocol ID
- 2019-259
- Status last verified
- Aug 2023
- First submitted
- 30 Oct 2019
- Last updated
- 31 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Control in Septum and Sinus Surgery: A Novel Approach.
- ClinicalTrials.gov ID
- NCT04149964
- Acronym / sponsor ID
- 2019-259
- Conditions
- Post-operative Pain, Sinus Surgery
- Keywords
- Post-operative pain, Sinus pain, Sinus surgery, Septum Pain, deviated septum
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- 27 Nov 2019 (actual)
- Primary completion
- 21 Sep 2022 (actual)
- Study completion
- 21 Sep 2022 (actual)
- First posted
- 4 Nov 2019 (actual)
- Results
- Posted 31 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care arm | Active comparator | Drug: Acetaminophen 325 mg Oral Tablet, Drug: Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tabletStandard 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. |
| Study Arm | Experimental | Drug: Acetaminophen 650 mg Oral Tablet, Drug: OxyCODONE 5 mg Oral TabletAcetaminophen 650 mg 1 tab every 6 hours round the clock plus Oxycodone 5 mg 1 tab every 6 hours as needed for breakthrough pain,. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetaminophen 325 mg Oral TabletAlso: Tylenol Standard StrengthStandard of Care Acetaminophen 325 mg every 6 hours as needed for pain | Drug | Standard of Care arm |
| Acetaminophen 650 mg Oral TabletAlso: Tylenol Extra StrengthAcetaminophen 650 mg scheduled every 6 hours round the clock for pain | Drug | Study Arm |
| OxyCODONE 5 mg Oral TabletAlso: Percodan, PercocetOxycodone 5 mg every 4 hours as needed for breakthrough pain | Drug | Study Arm |
| Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tabletAlso: NorcoAcetaminophen 325 mg/ Hydrocodone 7.5 mg oral tablet every 4 hours as needed for breakthrough pain | Drug | Standard of Care arm |
Primary outcome
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.
8 secondary outcomes
Highest Subjective Pain Score
Time frame: 7 days
Lowest Subjective Pain Score
Time frame: 7 days
Percentage of Time Participant Experienced Severe Pain
Time frame: 7 days
Participant Use of Acetaminophen as Needed
Time frame: 7 days
Participant Use of Scheduled Acetaminophen Around the Clock
Time frame: 7 days
Chronic Use of Pain Medication
Time frame: 7 days
Participant Use of Additional Pain Medication
Time frame: 7 days
Types of Other Pain Medication Used
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Seel, DO. principal investigator
William Beaumont Hospital - Farmington Hills
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetaminophen 325 mg Oral Tablet, Acetaminophen 650 mg Oral Tablet and OxyCODONE 5 mg Oral Tablet in people with Post-operative Pain and Sinus Surgery, run by Corewell Health East at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Doses of Opiate (Narcotic) Pain Medication (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.