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

Chronic Rhinosinusitis (Diagnosis) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05287217
• Other study ID #: 2021-1249
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 29, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2022
• Source: University of Illinois at Chicago
• Contact: Stephanie Joe, MD
• Phone: 312-996-6582
• Email: sjoe[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Rhinosinusitis (Diagnosis)
• Pain, Postoperative

Intervention

Other:
• Comparison of medication administration for pain control
Measuring pain control following FESS surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stephanie Joe

References & Publications (14)

[2] Substance Abuse and Mental Health Services Administration. (2019). Key substance use and mental health indicators in the United States: Results from the 2018 National Survey on Drug Use and Health (HHS Publication No. PEP19-5068, NSDUH Series H-54). Rockville, MD: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. Retrieved from https://www.samhsa.gov/data/

Bhattacharyya N. Ambulatory sinus and nasal surgery in the United States: demographics and perioperative outcomes. Laryngoscope. 2010 Mar;120(3):635-8. doi: 10.1002/lary.20777. — View Citation

Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. — View Citation

Du E, Farzal Z, Stephenson E, Tanner A, Adams K, Farquhar D, Weissler M, Patel S, Blumberg J, Jowza M, Hackman T, Zanation A. Multimodal Analgesia Protocol after Head and Neck Surgery: Effect on Opioid Use and Pain Control. Otolaryngol Head Neck Surg. 2019 Sep;161(3):424-430. doi: 10.1177/0194599819841885. Epub 2019 Apr 9. — View Citation

Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005. — View Citation

Gao Y, Wang C, Wang G, Cui X, Yang G, Lou H, Zhang L. Benefits of Enhanced Recovery After Surgery in Patients Undergoing Endoscopic Sinus Surgery. Am J Rhinol Allergy. 2020 Mar;34(2):280-289. doi: 10.1177/1945892419892834. Epub 2019 Dec 4. — View Citation

Gray ML, Fan CJ, Kappauf C, Kidwai S, Colley P, Iloreta AM, Govindaraj S. Postoperative pain management after sinus surgery: a survey of the American Rhinologic Society. Int Forum Allergy Rhinol. 2018 Oct;8(10):1199-1203. doi: 10.1002/alr.22181. Epub 2018 Jul 18. — View Citation

Kemppainen TP, Tuomilehto H, Kokki H, Seppä J, Nuutinen J. Pain treatment and recovery after endoscopic sinus surgery. Laryngoscope. 2007 Aug;117(8):1434-8. — View Citation

Nguyen KK, Liu YF, Chang C, Park JJ, Kim CH, Hondorp B, Vuong C, Xu H, Crawley BK, Simental AA, Church CA, Inman JC. A Randomized Single-Blinded Trial of Ibuprofen- versus Opioid-Based Primary Analgesic Therapy in Outpatient Otolaryngology Surgery. Otolaryngol Head Neck Surg. 2019 May;160(5):839-846. doi: 10.1177/0194599819832528. Epub 2019 Mar 5. — View Citation

Oltman J, Militsakh O, D'Agostino M, Kauffman B, Lindau R, Coughlin A, Lydiatt W, Lydiatt D, Smith R, Panwar A. Multimodal Analgesia in Outpatient Head and Neck Surgery: A Feasibility and Safety Study. JAMA Otolaryngol Head Neck Surg. 2017 Dec 1;143(12):1207-1212. doi: 10.1001/jamaoto.2017.1773. — View Citation

Poljak D, Chappelle J. The effect of a scheduled regimen of acetaminophen and ibuprofen on opioid use following cesarean delivery. J Perinat Med. 2020 Feb 25;48(2):153-156. doi: 10.1515/jpm-2019-0322. — View Citation

Shelton FR, Ishii H, Mella S, Chew D, Winterbottom J, Walijee H, Brown R, Chisholm EJ. Implementing a standardised discharge analgesia guideline to reduce paediatric post tonsillectomy pain. Int J Pediatr Otorhinolaryngol. 2018 Aug;111:54-58. doi: 10.1016/j.ijporl.2018.05.020. Epub 2018 May 19. — View Citation

Svider PF, Nguyen B, Yuhan B, Zuliani G, Eloy JA, Folbe AJ. Perioperative analgesia for patients undergoing endoscopic sinus surgery: an evidence-based review. Int Forum Allergy Rhinol. 2018 Jul;8(7):837-849. doi: 10.1002/alr.22107. Epub 2018 Apr 12. Review. — View Citation

Wu AW, Walgama ES, Genç E, Ting JY, Illing EA, Shipchandler TZ, Higgins TS. Multicenter study on the effect of nonsteroidal anti-inflammatory drugs on postoperative pain after endoscopic sinus and nasal surgery. Int Forum Allergy Rhinol. 2020 Apr;10(4):489-495. doi: 10.1002/alr.22506. Epub 2019 Dec 13. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scheduled versus as needed pain management following FESS surgery	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	Does scheduled pain management decrease narcotic use.	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