Postoperative Pain Control in Septum and Sinus Surgery

NCT ID: NCT04149964

Last Updated: 2023-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-27
• Study Completion Date: 2022-09-21

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.

Conditions

Post-operative Pain; Sinus Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Acetaminophen 325 mg Oral Tablet

Intervention Type: DRUG

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

Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet

Intervention Type: DRUG

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

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,.

Group Type: EXPERIMENTAL

Acetaminophen 650 mg Oral Tablet

Intervention Type: DRUG

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

OxyCODONE 5 mg Oral Tablet

Intervention Type: DRUG

Oxycodone 5 mg every 4 hours as needed for breakthrough pain

Interventions

Acetaminophen 325 mg Oral Tablet

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

Intervention Type: DRUG

Acetaminophen 650 mg Oral Tablet

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

Intervention Type: DRUG

OxyCODONE 5 mg Oral Tablet

Oxycodone 5 mg every 4 hours as needed for breakthrough pain

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Tylenol Standard Strength; Tylenol Extra Strength; Percodan, Percocet; Norco

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

William Beaumont Hospitals

OTHER

Sponsor Role: lead

Responsible Party

David Seel

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Seel, DO.

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospital - Farmington Hills

Locations

Beaumont Hospital

Farmington Hills, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2019-259

Identifier Type: -

Identifier Source: org_study_id