Postoperative Pain Control in Septum and Sinus Surgery

Phase 4

Completed

Conditions: Post-operative Pain
Sinus Surgery

Interventions: Drug: Acetaminophen 325 mg Oral Tablet
Drug: Acetaminophen 650 mg Oral Tablet
Drug: Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet
Drug: OxyCODONE 5 mg Oral Tablet

Registration Number: NCT04149964

Lead Sponsor: William Beaumont Hospitals

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 65

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care arm	Acetaminophen 325 mg Oral Tablet	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.
Standard of Care arm	Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet	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.
Study Arm	Acetaminophen 650 mg Oral Tablet	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,.
Study Arm	OxyCODONE 5 mg Oral Tablet	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,.

Primary Outcome Measures

Name	Time	Method
Number of Doses of Opiate (Narcotic) Pain Medication	7 days	Number of doses of opiates (narcotic) pain medication participants took for breakthrough pain in the first postoperative week.

Secondary Outcome Measures

Name	Time	Method
Highest Subjective Pain Score	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.
Lowest Subjective Pain Score	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.
Percentage of Time Participant Experienced Severe Pain	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.
Participant Use of Acetaminophen as Needed	7 days	Number of participants who took acetaminophen as needed during the first postoperative week.
Participant Use of Scheduled Acetaminophen Around the Clock	7 days	Number of participants who took acetaminophen every 6 hours around the clock during first postoperative week.
Chronic Use of Pain Medication	7 days	Number of participants who answered "Yes" to the survey question, "Do you take pain medication, including narcotics, for any other medical condition?"
Participant Use of Additional Pain Medication	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.
Types of Other Pain Medication Used	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