Postoperative Pain Control in Septum and Sinus Surgery

Post-operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04149964
• Other study ID #: 2019-259
• Status: Completed
• Phase: Phase 4
• Start date: November 27, 2019
• Est. completion date: September 21, 2022

Study information

• Verified date: August 2023
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: September 21, 2022
• Est. primary completion date: September 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain
• Sinus Surgery

Intervention

Drug:
• Acetaminophen 325 mg Oral Tablet
Standard of Care Acetaminophen 325 mg every 6 hours as needed for pain
• Acetaminophen 650 mg Oral Tablet
Acetaminophen 650 mg scheduled every 6 hours round the clock for pain
• OxyCODONE 5 mg Oral Tablet
Oxycodone 5 mg every 4 hours as needed for breakthrough pain
• 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

Locations

Country	Name	City	State
United States	Beaumont Hospital	Farmington Hills	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Participant Use of Acetaminophen as Needed	Number of participants who took acetaminophen as needed during the first postoperative week.	7 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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