Post Operative Analgesia and Patient Satisfaction

NCT04976387 | Completed

• 1 other identifier: 52004443
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain; Patient Satisfaction; Analgesia

Keywords

Otolaryngology; Head and Neck surgery; Outpatient surgery; Same day surgery; Post operative pain; Patient satisfaction; Post operative analgesia; NSAID; Acetaminophen; Hydrocodone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Efficacy of analgesic regimen and patient attitudes toward treatment they received

  First clinic visit after surgery (7 days)

Study Arms (3)

Group 1: Hydrocodone/Acetaminophen and Ibuprofen

This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control If pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control.

Group 2: Ibuprofen and Hydrocodone/acetaminophen

This group will take Ibuprofen 600mg every 6 hours as needed for pain control If pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control.

Group 3: Ibuprofen and Acetaminophen

This group will take Ibuprofen 600mg every 6 hours as needed for pain control If pain is not controlled after 60 minutes then can take Acetaminophen 650mg every 6 hours as needed for additional pain control.

Interventions

Hydrocodone/Acetaminophen 5 Mg-325 Mg ORAL TABLET

Ibuprofen 600 mg

Acetaminophen 650 MG

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population is comprised of outpatients undergoing specific outpatient surgery procedures as outline in the inclusion criteria, at an LLUHS associated surgical facility.

You may qualify if:

• Patients between the ages of 18 and 89 years of age
• Patients undergoing the following outpatient procedures:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Health System

Loma Linda, California, 92354, United States

Location

Related Publications (14)

• 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.

  PMID: 32191688 BACKGROUND

• 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.

  PMID: 31846008 BACKGROUND

• 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.

  PMID: 30646062 BACKGROUND

• 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.

  PMID: 31774562 BACKGROUND

• 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.

  PMID: 31225905 BACKGROUND

• 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.

  PMID: 17298314 BACKGROUND

• 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.

  PMID: 26422088 BACKGROUND

• 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.

  PMID: 30286851 BACKGROUND

• 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.

  PMID: 26824844 BACKGROUND

• 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.

  PMID: 31834679 BACKGROUND

• 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.

  PMID: 32127178 BACKGROUND

• 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.

  PMID: 30832548 BACKGROUND

• 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.

  PMID: 32536501 BACKGROUND

• 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.

  PMID: 31154092 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Patient Satisfaction; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Khanh Nguyen, MD

  Loma Linda University Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 26, 2021
• Study Start: July 2, 2021
• Primary Completion: May 11, 2023
• Study Completion: May 11, 2023
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)