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Clinical Trials/NCT04976387
NCT04976387
Completed
Phase 3

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

Loma Linda University1 site in 1 country160 target enrollmentJuly 2, 2021

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Postoperative Pain
Sponsor
Loma Linda University
Enrollment
160
Locations
1
Primary Endpoint
Patient satisfaction with post operative pain control
Status
Completed
Last Updated
last month

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2, 2021
End Date
May 11, 2023
Last Updated
last month
Study Type
Observational
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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.

Outcomes

Primary Outcomes

Patient satisfaction with post operative pain control

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

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.

Secondary Outcomes

  • Efficacy of analgesic regimen and patient attitudes toward treatment they received(First clinic visit after surgery (7 days))

Study Sites (1)

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