Post Operative Analgesia and Patient Satisfaction

August 7, 2023 updated by: Loma Linda University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Jaibir S Pannu, M.D.
  • Phone Number: 88558 909-558-4000
  • Email: jpannu@llu.edu

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Hydrocodone/Acetaminophen 5 Mg-325 Mg ORAL TABLET
Patients are instructed to take Hydrocodone/acetaminophen 5 mg-325 mg oral tablets every 6 hours as needed for treatment of severe pain
Other Names:
  • Norco
Drug: Ibuprofen 600 mg
Patients will take ibuprofen 600 mg every 6 hours as needed
Other Names:
  • Advil, Motrin, NSAID
Experimental: 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.
Drug: Hydrocodone/Acetaminophen 5 Mg-325 Mg ORAL TABLET
Patients are instructed to take Hydrocodone/acetaminophen 5 mg-325 mg oral tablets every 6 hours as needed for treatment of severe pain
Other Names:
  • Norco
Drug: Ibuprofen 600 mg
Patients will take ibuprofen 600 mg every 6 hours as needed
Other Names:
  • Advil, Motrin, NSAID
Experimental: 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.
Drug: Ibuprofen 600 mg
Patients will take ibuprofen 600 mg every 6 hours as needed
Other Names:
  • Advil, Motrin, NSAID
Drug: Acetaminophen 650 MG
Patients will take Tylenol 650mg every 6 hours as needed
Other Names:
  • Tylenol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
First clinic visit after surgery (7 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of analgesic regimen and patient attitudes toward treatment they received
Time Frame: First 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?
First clinic visit after surgery (7 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Investigators

  • Principal Investigator: Khanh Nguyen, MD, Loma Linda University Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2021

Primary Completion (Actual)

May 11, 2023

Study Completion (Actual)

May 11, 2023

Study Registration Dates

First Submitted

July 15, 2021

First Submitted That Met QC Criteria

July 15, 2021

First Posted (Actual)

July 26, 2021

Study Record Updates

Last Update Posted (Actual)

August 8, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 52004443

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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