Post Operative Analgesia and Patient Satisfaction

Postoperative Pain Clinical Trial

Official title:

Assessing Perceived Quality of Care With Differing Pain Management Protocols After Outpatient Otolaryngology Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04976387
• Other study ID #: 52004443
• Status: Completed
• Phase: Phase 3
• Start date: July 2, 2021
• Est. completion date: May 11, 2023

Study information

• Verified date: August 2023
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To understand how patients perceive the quality of care they receive when given different post-operative analgesic medications. Specifically the investigators want to assess whether patients who receive non-opioid analgesia following surgery endorse appropriate quality and satisfaction with their care compared to those who receive opioid medication.

Description:

It is routine practice to give analgesic medication after any surgical procedure to provide adequate pain control for patients. However with the increase in abuse of opioid prescription medications, physicians have given a new emphasis to different pain regimens that aim to limit the use of opioid medications. The investigator's previous clinical trial demonstrated that for patients undergoing outpatient otolaryngology procedures, not only does Ibuprofen provide equally effective analgesia compared to opioid medication but it can also decrease overall opioid requirement.

In the current proposed study, the investigators wish to build on previous work. The investigators hypothesize that with the addition of Acetaminophen to Ibuprofen, patients undergoing outpatient otolaryngology procedures may not require opioid analgesia at all. While numerous studies corroborate these results, there is little information about patients' satisfaction with their care in light of a shifting emphasis on decreasing opioid prescription. The primary goal of the current study is to better understand patients' perception of care and level of satisfaction when given opioid versus non-opioid postoperative analgesia. If there is conflicting data with regards to patients reporting adequate pain control but poor satisfaction, then perhaps further public health intervention may be necessary to provide additional patient education to help re-establish appropriate and safe patient expectations for postsurgical analgesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 11, 2023
• Est. primary completion date: May 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Patients between the ages of 18 and 89 years of age

• Patients undergoing the following outpatient procedures at a LLUHS associated surgical facility:

• total or partial thyroidectomy

• parathyroidectomy

• parotidectomy

• submandibular gland excision

• neck mass excision

• facial mass excision

• MOHS defect repair

• excision of cutaneous lesions

• Other surgeries may qualify and will be assessed on a case by case basis.

Exclusion Criteria:

• Patients under 18 years old or older than 89 years old

• Those allergic to Hydrocodone, Acetaminophen, or NSAIDS

• Patients who are pregnant

• Patients with chronic medical conditions including hepatic/renal disease that precludes their ability to utilize the study medications.

Related Conditions & MeSH terms

• Analgesia
• Pain, Postoperative
• Patient Satisfaction
• Postoperative Pain

Intervention

Drug:
• Hydrocodone/Acetaminophen 5 Mg-325 Mg ORAL TABLET
Patients are instructed to take Hydrocodone/acetaminophen 5 mg-325 mg oral tablets every 6 hours as needed for treatment of severe pain
• Ibuprofen 600 mg
Patients will take ibuprofen 600 mg every 6 hours as needed
• Acetaminophen 650 MG
Patients will take Tylenol 650mg every 6 hours as needed

Locations

Country	Name	City	State
United States	Loma Linda University Health System	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

References & Publications (14)

Bartels K, Mayes LM, Dingmann C, Bullard KJ, Hopfer CJ, Binswanger IA. Opioid Use and Storage Patterns by Patients after Hospital Discharge following Surgery. PLoS One. 2016 Jan 29;11(1):e0147972. doi: 10.1371/journal.pone.0147972. eCollection 2016. — View Citation

Dang S, Duffy A, Li JC, Gandee Z, Rana T, Gunville B, Zhan T, Curry J, Luginbuhl A, Cottrill E, Cognetti D. Postoperative opioid-prescribing practices in otolaryngology: A multiphasic study. Laryngoscope. 2020 Mar;130(3):659-665. doi: 10.1002/lary.28101. Epub 2019 Jun 21. — View Citation

Foghsgaard S, Foghsgaard J, Homoe P. Early post-operative morbidity after superficial parotidectomy: a prospective study concerning pain and resumption of normal activity. Clin Otolaryngol. 2007 Feb;32(1):54-7. doi: 10.1111/j.1365-2273.2007.01315.x. — View Citation

Gomes T, Tadrous M, Mamdani MM, Paterson JM, Juurlink DN. The Burden of Opioid-Related Mortality in the United States. JAMA Netw Open. 2018 Jun 1;1(2):e180217. doi: 10.1001/jamanetworkopen.2018.0217. — View Citation

Gostian AO, Loeser J, Tholen C, Wolber P, Otte M, Schwarz D, Heindl LM, Balk M, Gostian M. Postoperative pain after tonsillectomy - the value of standardized analgesic treatment protocols. Auris Nasus Larynx. 2020 Dec;47(6):1009-1017. doi: 10.1016/j.anl.2020.05.011. Epub 2020 Jun 12. — View Citation

Hallway A, Vu J, Lee J, Palazzolo W, Waljee J, Brummett C, Englesbe M, Howard R. Patient Satisfaction and Pain Control Using an Opioid-Sparing Postoperative Pathway. J Am Coll Surg. 2019 Sep;229(3):316-322. doi: 10.1016/j.jamcollsurg.2019.04.020. Epub 2019 May 30. — View Citation

Ilyas AM, Miller AJ, Graham JG, Matzon JL. Pain Management After Carpal Tunnel Release Surgery: A Prospective Randomized Double-Blinded Trial Comparing Acetaminophen, Ibuprofen, and Oxycodone. J Hand Surg Am. 2018 Oct;43(10):913-919. doi: 10.1016/j.jhsa.2018.08.011. — 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

Olfson M, Rossen LM, Wall MM, Houry D, Blanco C. Trends in Intentional and Unintentional Opioid Overdose Deaths in the United States, 2000-2017. JAMA. 2019 Dec 17;322(23):2340-2342. doi: 10.1001/jama.2019.16566. — View Citation

Papoian V, Handy KG, Villano AM, Tolentino RA, Hassanein MT, Nosanov LS, Felger EA. Randomized control trial of opioid- versus nonopioid-based analgesia after thyroidectomy. Surgery. 2020 Jun;167(6):957-961. doi: 10.1016/j.surg.2020.01.011. Epub 2020 Feb 29. — View Citation

Pruitt LCC, Casazza GC, Newberry CI, Cardon R, Ramirez A, Krakovitz PR, Meier JD, Skarda DE. Opioid Prescribing and Use in Ambulatory Otolaryngology. Laryngoscope. 2020 Aug;130(8):1913-1921. doi: 10.1002/lary.28359. Epub 2019 Nov 27. — View Citation

Song CM, Ji YB, Bang HS, Kim KR, Kim H, Tae K. Postoperative Pain After Robotic Thyroidectomy by a Gasless Unilateral Axillo-Breast or Axillary Approach. Surg Laparosc Endosc Percutan Tech. 2015 Dec;25(6):478-82. doi: 10.1097/SLE.0000000000000204. — View Citation

Wilson N, Kariisa M, Seth P, Smith H 4th, Davis NL. Drug and Opioid-Involved Overdose Deaths - United States, 2017-2018. MMWR Morb Mortal Wkly Rep. 2020 Mar 20;69(11):290-297. doi: 10.15585/mmwr.mm6911a4. — View Citation

Wu AW, Walgama ES, Genc 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	Patient satisfaction with post operative pain control	Patients will be surveyed if they were satisfied with their pain regimen and efficacy of pain control on a scale of 1-5. With 1 being very unsatisfied and 5 being very satisfied.	First clinic visit after surgery (7 days)
Secondary	Efficacy of analgesic regimen and patient attitudes toward treatment they received	Patients attitude and overall experience with regards to their pain management will be assessed via the following questions: How many total days do you estimate that you required medication for your pain?; If you were in a group that received hydrocodone, how many pills do you estimate that you took?; If you were to have another surgery, would you ask your surgeon for a similar pain regimen?; Was this surgery more painful than you anticipated?	First clinic visit after surgery (7 days)