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Post Operative Analgesia and Patient Satisfaction

Primary Purpose

Postoperative Pain, Patient Satisfaction, Analgesia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Hydrocodone/Acetaminophen 5 Mg-325 Mg ORAL TABLET
Ibuprofen 600 mg
Acetaminophen 650 MG
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Otolaryngology, Head and Neck surgery, Outpatient surgery, Same day surgery, Post operative pain, Patient satisfaction, Post operative analgesia, NSAID, Acetaminophen, Hydrocodone

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Loma Linda University Health System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group 1: Hydrocodone/Acetaminophen and Ibuprofen

Group 2: Ibuprofen and Hydrocodone/acetaminophen

Group 3: Ibuprofen and Acetaminophen

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 15, 2021
Last Updated
August 7, 2023
Sponsor
Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT04976387
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 2, 2021 (Actual)
Primary Completion Date
May 11, 2023 (Actual)
Study Completion Date
May 11, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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.
Masking
InvestigatorOutcomes Assessor
Masking Description
Researchers will not be blinded during the process of recruitment of patients due to necessity of prescribing specific medications. Researchers will be blinded during outcome assessment and data analysis.
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Hydrocodone/Acetaminophen and Ibuprofen
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2: Ibuprofen and Hydrocodone/acetaminophen
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 3: Ibuprofen and Acetaminophen
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Hydrocodone/Acetaminophen 5 Mg-325 Mg ORAL TABLET
Other Intervention Name(s)
Norco
Intervention Description
Patients are instructed to take Hydrocodone/acetaminophen 5 mg-325 mg oral tablets every 6 hours as needed for treatment of severe pain
Intervention Type
Drug
Intervention Name(s)
Ibuprofen 600 mg
Other Intervention Name(s)
Advil, Motrin, NSAID
Intervention Description
Patients will take ibuprofen 600 mg every 6 hours as needed
Intervention Type
Drug
Intervention Name(s)
Acetaminophen 650 MG
Other Intervention Name(s)
Tylenol
Intervention Description
Patients will take Tylenol 650mg every 6 hours as needed
Primary Outcome Measure Information:
Title
Patient satisfaction with post operative pain control
Description
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 Outcome Measure Information:
Title
Efficacy of analgesic regimen and patient attitudes toward treatment they received
Description
Patients attitude and overall experience with regards to their pain management will be assessed via the following questions: How many total days do you estimate that you required medication for your pain? If you were in a group that received hydrocodone, how many pills do you estimate that you took? If you were to have another surgery, would you ask your surgeon for a similar pain regimen? Was this surgery more painful than you anticipated?
Time Frame
First clinic visit after surgery (7 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khanh Nguyen, MD
Organizational Affiliation
Loma Linda University Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University Health System
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share participants data after this study is finished with other researchers.
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Post Operative Analgesia and Patient Satisfaction

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