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CompletedNCT04976387Updated Mar 30, 2026

Post Operative Analgesia and Patient Satisfaction

An observational study in Postoperative Pain, Patient Satisfaction and Analgesia, sponsored by Loma Linda University. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-30.

Sponsored by Loma Linda University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
160
Ages
18 Years to 89 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • 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
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 160 is above the median of 102 across 608 observational studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Loma Linda University is the lead sponsor of 297 studies on the registry; 48 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 23 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Inclusion criteria

  • 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.

Exclusion criteria

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
160 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

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.

    Time frame: First clinic visit after surgery (7 days)

Secondary outcomes

  1. 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: 1. How many total days do you estimate that you required medication for your pain? 2. If you were in a group that received hydrocodone, how many pills do you estimate that you took? 3. If you were to have another surgery, would you ask your surgeon for a similar pain regimen? 4. Was this surgery more painful than you anticipated?

    Time frame: First clinic visit after surgery (7 days)

07

Study locations

1 site
  • Loma Linda University Health System
    Loma Linda, California 92354, United States
08

References and documents

Publications

  • 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. PubMed 32191688 ↗
  • 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. PubMed 31846008 ↗
  • 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. PubMed 30646062 ↗
  • 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. PubMed 31774562 ↗
  • 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. PubMed 31225905 ↗
  • 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. PubMed 17298314 ↗
  • 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. PubMed 26422088 ↗
  • 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. PubMed 30286851 ↗
  • 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. PubMed 26824844 ↗
  • 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. PubMed 31834679 ↗
  • 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. PubMed 32127178 ↗
  • 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. PubMed 30832548 ↗
  • 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. PubMed 32536501 ↗
  • 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. PubMed 31154092 ↗

Individual participant data

Plan to share: No — There is no plan to share participants data after this study is finished with other researchers.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04976387
Lead sponsor
Loma Linda University
Responsible party
Sponsor
First posted
Jul 26, 2021
Start date
Jul 2, 2021
Primary completion
May 11, 2023
Completion
May 11, 2023
Last update
Mar 30, 2026

Study contacts

Khanh Nguyen, MD
principal investigator · Loma Linda University Health System

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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