Post-operative Pain Control With Acetaminophen and Ibuprofen After Functional Endoscopic Sinus Surgery

June 17, 2022 updated by: Stephanie Joe

Post-operative Pain Control With Acetaminophen and Ibuprofen After Functional Endoscopic Sinus Surgery for Chronic Rhinosinusitis: a Prospective Study.

The safest and most effective post-operative pain control regimen after functional endoscopic sinus surgery (FESS) has been the subject of persistent research. This prospective study will compare post-operative pain control when managed either by a defined medication schedule or medication taken on an as-needed basis after functional endoscopic sinus surgery for chronic rhinosinusitis.

Prior to surgery, patients will be randomly selected to be in one of two treatment arms. One group will receive instructions to take specific medications (acetaminophen and ibuprofen on a specific schedule post-operatively. The second treatment groups will be instructed to take the same medications but on an as needed basis for pain. Patients will also be provided with an option of a limited supply of narcotic analgesics for pain should they be needed.

Post-operative pain control will be assessed by the patient with a pain-diary documenting perceived levels of pain for 10 days post-operatively using a validated visual analog scale. At the conclusion of the study the records of medications taken along with pain responses will be compared between groups

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The safest and most effective post-operative pain control regimen after functional endoscopic sinus surgery (FESS) has been the subject of persistent debate and research for many years. The main reasons for this debate is due to two factors: 1) endoscopic sinus surgery is a commonly performed as an outpatient procedure by both generalist and sub-specialized Otolaryngologists. Therefore, there is limited controlled data on pain levels and pain control post-surgery. 2) The ongoing opiate crisis in the United States raises concern of over-prescribing narcotic pain medication post-surgery when it is not necessary.

Of the 600,000 ambulatory sinonasal procedures performed annually in the United States, over 255,000 are sinus surgeries.1 Coupled with an estimated 2 million Americans suffering from opioid use disorders, there is a necessity for further research into minimizing the use of opioids for pain management as well as for testing non-opioid pain management options for postoperative FESS patients.

This study builds on prior research studying optimal non-narcotic analgesia after FESS. A 2018 survey by the American Rhinologic Society showed that over 90% of responders prescribed at least one type of opioid for postoperative pain after FESS. While the majority of Otolaryngologists routinely prescribe opioids, several studies have demonstrated that acetaminophen and NSAIDs can be just as effective in managing postoperative pain in FESS patients. Despite prior concerns that ibuprofen increases risk of epistaxis after FESS, it has been shown that bleeding complications following FESS are negligible.

Recent literature in other surgical sub-specialties has shown that scheduled non-narcotic pain medication significantly reduced patient's post-operative pain scores as compared to those taking it on an as-needed basis.6 In Otolaryngology, the practice of scheduled acetaminophen and ibuprofen has been documented to reduce admissions due to post-tonsillectomy pain.7 Despite the rising trend of non-narcotic pain regimens after surgery, the most appropriate method for instituting this in FESS patients has only been briefly evaluated. A 2006 study showed that scheduled medication use versus as-needed modified-release acetaminophen allowed patients to return to normal daily activities more rapidly and with less pain than patients taking post-operative pain medications on an as needed basis. However, this pain regimen did not include NSAIDs, and modified release acetaminophen is not commonly available in the United States.

This study will evaluate post-operative pain management in patients undergoing outpatient functional endoscopic sinus surgery. Patients will be randomized into one of two study groups: Group 1: Patients instructed to follow a predetermined post-operative acetaminophen and ibuprofen medication schedule, and Group 2: patients instructed to take acetaminophen and ibuprofen as needed after the onset of pain/discomfort. Additionally, all patients in both study groups will be provided a limited number of narcotic pills (Norco) for pain. Patients will be advised to only take the pills for pain that is not controlled by the post-operative acetaminophen and ibuprofen medications.

Pain control will be self-assessed by each patient for the first 10 days after surgery using a validated visual-analog scale (VAS).

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Stephanie Joe, MD
  • Phone Number: 312-996-6582
  • Email: sjoe@uic.edu

Study Contact Backup

  • Name: Kevin M O'Grady, BS
  • Phone Number: 312-996-6508
  • Email: kogrady@uic.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females ≥18 years of age.
  • Patients of the PI (Dr. Joe) scheduled for sinus surgery at UI Health.
  • Patients with CRS defined as greater than 12 weeks of 2 of the 4 following symptoms: nasal obstruction/congestion, mucopurulent discharge (nasal or postnasal), facial pain/pressure, or decreased/loss of smell + endoscopic/radiographic evidence of disease.
  • CRS patients with or without nasal polyps.
  • Patients who are COVID-19 negative.
  • Patients that understand the purpose and procedures of the study and who agree to participate.
  • Patients who have the capacity to consent autonomously.

Exclusion Criteria:

  • Males and females < 18 years of age.
  • Patients of the PI (Dr. Joe) who are not scheduled for sinus surgery at UI Health.
  • Patients who do not have CRS.
  • Patients who have allergies to acetaminophen, ibuprofen, and related non-steroidal anti-inflammatory drugs (NSAIDS).
  • Patients with kidney or liver dysfunction, cirrhosis, metabolic deficiencies, inflammatory bowel disease, peptic ulcer disease, chronic malnutrition, who have had a previous skull base surgery, or who are currently undergoing cancer treatment.
  • Woman who are pregnant or breastfeeding will be excluded.
  • Patients with a history of drug and/or narcotic abuse will be excluded.
  • COVID-19 positive patients.
  • Patients who are not able to understand the purpose and procedures of the study and who do not wish to participate.
  • Patients that do not have the capacity to consent autonomously.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1: Scheduled pain control
Group 1 patients will be instructed to take 650mg of acetaminophen every 6 hours and 600mg of ibuprofen every 8 hours for 10 consecutive days after surgery regardless of whether they experience pain or not.
Other: Comparison of medication administration for pain control
Measuring pain control following FESS surgery
Active Comparator: Group 2: Pain control as needed.
Group 2 patients will be instructed to take the 650mg of acetaminophen every 6 hours and 600mg of ibuprofen every 8 hours for 10 days after surgery only when needed to control pain.
Other: Comparison of medication administration for pain control
Measuring pain control following FESS surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scheduled versus as needed pain management following FESS surgery
Time Frame: 10 days
The primary outcome measure will compare patient self-assessed pain levels, between the 2 study groups, using a Faces Pain Scale Record. The faces pain scale ranges from 0 to 10 with 0 being no pain and 10 being worst possible pain. Each number on the scale is associated with a pain description and an animated face associated with the description.
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Does scheduled pain management decrease narcotic use.
Time Frame: 10 days
The second outcome measure will quantify (count) the number of narcotic (Norco) pills taken by each patient post-operatively in the 2 study groups.
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stephanie Joe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 29, 2022

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

February 1, 2022

First Submitted That Met QC Criteria

March 10, 2022

First Posted (Actual)

March 18, 2022

Study Record Updates

Last Update Posted (Actual)

June 22, 2022

Last Update Submitted That Met QC Criteria

June 17, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-1249

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

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Rhinosinusitis (Diagnosis)

Clinical Trials on Comparison of medication administration for pain control

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe