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Completed

NCT Number: NCT04149964

Postoperative Pain Control in Septum and Sinus Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beaumont Hospital

Farmington Hills, Michigan, 48336, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetaminophen 325 mg Oral Tablet

Drug

Standard of Care Acetaminophen 325 mg every 6 hours as needed for pain

Other names: Tylenol Standard Strength

Acetaminophen 650 mg Oral Tablet

Drug

Acetaminophen 650 mg scheduled every 6 hours round the clock for pain

Other names: Tylenol Extra Strength

OxyCODONE 5 Mg Oral Tablet

Drug

Oxycodone 5 mg every 4 hours as needed for breakthrough pain

Other names: Percodan, Percocet

Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet

Drug

Acetaminophen 325 mg/ Hydrocodone 7.5 mg oral tablet every 4 hours as needed for breakthrough pain

Other names: Norco

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Corewell Health East

Other

Registry information

Official study title

Postoperative Pain Control in Septum and Sinus Surgery: A Novel Approach.

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 4, 2019
Registry last updated
Aug 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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