Postoperative Pain Control in Septum and Sinus Surgery

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.

Study Overview

• Status: Completed
• Conditions: Post-operative Pain; Sinus Surgery
• Intervention / Treatment: Drug: Acetaminophen 325 mg Oral Tablet; Drug: Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet; Drug: Acetaminophen 650 mg Oral Tablet; Drug: OxyCODONE 5 mg Oral Tablet

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: Interventional
• Enrollment (Actual): 65
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Farmington Hills, Michigan, United States, 48336
      • Beaumont Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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)

Number of Arms

2

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.	Drug: Acetaminophen 325 mg Oral Tablet; Standard of Care Acetaminophen 325 mg every 6 hours as needed for pain; Other Names: 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 Names: 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 Names: Tylenol Extra Strength; Drug: OxyCODONE 5 mg Oral Tablet; Oxycodone 5 mg every 4 hours as needed for breakthrough pain; Other Names: Percodan, Percocet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	7 days
Participant Use of Acetaminophen as Needed	Number of participants who took acetaminophen as needed during the first postoperative week.	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.	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?"	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.	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	7 days

Collaborators and Investigators

• Sponsor: William Beaumont Hospitals
• Investigators: Principal Investigator: David Seel, DO., William Beaumont Hospital - Farmington Hills

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2019
• Primary Completion (Actual): September 21, 2022
• Study Completion (Actual): September 21, 2022

Study Registration Dates

• First Submitted: October 30, 2019
• First Submitted That Met QC Criteria: October 30, 2019
• First Posted (Actual): November 4, 2019

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Post-operative pain; deviated septum; Sinus surgery; Sinus pain; Septum Pain
• 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)?: NO

Drug and device information, study documents

• 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