Postoperative Pain Control in Septum and Sinus Surgery

Sponsor

William Beaumont Hospitals (Other)

Overall Status

Recruiting

CT.gov ID

NCT04149964

Collaborator

(none)

200

Enrollment

Location

Arms

47.1

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post-operative Pain Sinus Surgery	Drug: Acetaminophen 325 mg Oral Tablet Drug: Acetaminophen 650 mg Oral Tablet Drug: OxyCODONE 5 mg Oral Tablet Drug: Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Open, randomized into one of two arms study. Study arm 1: Standard of care arm of Acetaminophen (Tylenol) 325 mg every 6 hours as needed plus acetaminophen/hydrocodone 7.5 mg/325mg every 4 hours for breakthrough pain. Study arm 2: Acetaminophen 650 mg. every 6 hours round the clock plus 5 mg oxycodone every 4 hours as needed for breakthrough pain.Open, randomized into one of two arms study. Study arm 1: Standard of care arm of Acetaminophen (Tylenol) 325 mg every 6 hours as needed plus acetaminophen/hydrocodone 7.5 mg/325mg every 4 hours for breakthrough pain. Study arm 2: Acetaminophen 650 mg. every 6 hours round the clock plus 5 mg oxycodone every 4 hours as needed for breakthrough pain.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 27, 2019

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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