MedPath

Post Operative Analgesia and Patient Satisfaction

Phase 3
Completed
Conditions
Patient Satisfaction
Postoperative Pain
Analgesia
Interventions
Drug: Hydrocodone/Acetaminophen 5 Mg-325 Mg ORAL TABLET
Registration Number
NCT04976387
Lead Sponsor
Loma Linda University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
150
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group 3: Ibuprofen and AcetaminophenIbuprofen 600 mgThis 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.
Group 1: Hydrocodone/Acetaminophen and IbuprofenHydrocodone/Acetaminophen 5 Mg-325 Mg ORAL TABLETThis 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/acetaminophenHydrocodone/Acetaminophen 5 Mg-325 Mg ORAL TABLETThis 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 1: Hydrocodone/Acetaminophen and IbuprofenIbuprofen 600 mgThis 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/acetaminophenIbuprofen 600 mgThis 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 AcetaminophenAcetaminophen 650 MGThis 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.
Primary Outcome Measures
NameTimeMethod
Patient satisfaction with post operative pain controlFirst 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 Outcome Measures
NameTimeMethod
Efficacy of analgesic regimen and patient attitudes toward treatment they receivedFirst clinic visit after surgery (7 days)

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?

Trial Locations

Locations (1)

Loma Linda University Health System

🇺🇸

Loma Linda, California, United States

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