Clinical trial NCT04976387: Post Operative Analgesia and Patient Satisfaction
Official title: Assessing Perceived Quality of Care With Differing Pain Management Protocols After Outpatient Otolaryngology Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2021-07-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to one of three groups prior to surgery. Patients will be prescribed Hydrocodone/acetaminophen, Ibuprofen, and/or Acetaminophen. Patients assigned to treatment Group 1 will take the opioid medication for initial pain control followed by Ibuprofen if pain is not adequately controlled. Group 2 patients will take Ibuprofen for initial pain control followed by the opioid medication if pain is not adequately controlled. Group 3 patients will take Ibuprofen for initial pain control followed by Acetaminophen if pain is not adequately controlled.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient satisfaction with post operative pain control
timeFrame: First clinic visit after surgery (7 days)
Secondary outcomes:
measure: Efficacy of analgesic regimen and patient attitudes toward treatment they received
timeFrame: First clinic visit after surgery (7 days)
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Health System
state: California
Study officials:
affiliation: Loma Linda University Health System
name: Khanh Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
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