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Pain Management Following Sinus Surgery

Primary Purpose

Nasal Sinus; Inflammation, Opioid Abuse, Pain, Postoperative

Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ibuprofen 600Mg Tablet
Standard Regimen | Tylenol
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasal Sinus; Inflammation focused on measuring NSAIDs, post-operative pain, post-operative hemorrhage, Functional endoscopic sinus surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

• All patients age 18-65 undergoing functional endoscopic sinus surgery +/- nasal airway surgery (septoplasty and/or inferior turbinate reduction).

Exclusion Criteria:

  • Not taking anti-coagulation medications including aspirin
  • Clinical Diagnosis of aspirin-exacerbated respiratory disease
  • Clinical Diagnosis of Cystic Fibrosis
  • Clinical Diagnosis of Primary Ciliary Dyskinesia
  • Inclusion of a Draf III frontal sinusotomy
  • Clinical Diagnosis of Liver/Kidney Failure
  • Clinical Diagnosis of Thrombocytopenia
  • Clinical Diagnosis of Poorly controlled hypertension
  • Clinical Diagnosis of Recent GI ulcers or gastritis
  • Clinical Diagnosis of Chronic pain as defined by a narcotic prescription with 6 months or involvement in a pain management program
  • Clinical Diagnosis of Primary Headache disorder
  • The use of nasal decongestants in the post-operative period.
  • The use of nasal packing or absorbable biomaterials.

Sites / Locations

  • University of Nebraska Medical Center
  • University of Cincinnati

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Standard Tylenol Regimen

Ibuprofen 600mg

Arm Description

Patient will be given a standard regimen: Tylenol 1000 mg by mouth every 6 hours scheduled and a rescue prescription of oxycodone 5 mg tablets by mouth every 6 hours as needed for pain. Ten total oxycodone tablets will be prescribed.

Tylenol 1000 mg by mouth every 6 hours scheduled and ibuprofen 600 mg tablet by mouth every 8 hours scheduled and a rescue prescription of oxycodone 5 mg tablets by mouth every 6 hours as needed for pain. Ten total oxycodone tablets will be prescribed.

Outcomes

Primary Outcome Measures

Pain level
Patients will be given a Visual Analogue scale to help document their level of pain from Post-operative days 0, 1, 2, 3, 4 ,5 and the first post-operative visit with the surgeon. The patient will measure their pain score each time they take medication. The pain scale called the Wong-Baker FACES pain rating scale is a 0-10 pain scale. 0 = no hurt, 2 = hurts little bit, 4 = hurts little more, 6 = hurts even more, 8 = hurts whole lot, 10 = hurts worst. The numbers are added up to a sum and put into their perspective category known by the Otolaryngologist.

Secondary Outcome Measures

Rate of bleeding
Any physician visits secondary to bleeding will be tabulated including ER and office visits.

Full Information

First Posted
January 28, 2019
Last Updated
August 30, 2023
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT03822962
Brief Title
Pain Management Following Sinus Surgery
Official Title
Post-operative Pain Management Following Functional Endoscopic Sinus Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Decrease in accrual during the COVID-19 pandemic and several sites withdrawing
Study Start Date
November 7, 2020 (Actual)
Primary Completion Date
May 30, 2023 (Actual)
Study Completion Date
May 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska

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
Yes

5. Study Description

Brief Summary
This Study evaluates the effect of adding Non-steroidal anti-inflammatories (NSAIDs) to the post-operative pain management of sinus surgery patients and wether or not this addition reduces or eliminates the need for narcotic pain medications. Patients will be instructed to take an NSAID regimen after surgery and will be instructed to take narcotics only for breakthrough pain.
Detailed Description
National attention has been given to the concerning rise of opioid abuse in this country, with prescriptions for this medications more than quadrupaling in the last 17 years. Little is known as to the appropriate use of opioid analgesics in the post-operative recovery of patients undergoing sinus surgery. Furthermore, most pain protocols include only Tylenol based opioid analgesics. No study has prospectively evaluated the volume of use of Tylenol based opioid analgesics and whether the addition of NSAIDS decreased the need for opioid analgesics. This study will compare opioid use with and without the addition of NSAIDS following sinus surgery. Post-operative opioid use is a great public health concern, relatively unstudied, and an area with an opportunity for potential intervention to significantly reduce risks, morbidity, and mortality to our postoperative patients by better formulating a postoperative pain management plan using evidence-based practices. Appropriate opioid prescribing practices can reduce the risk of addiction, drug overdose, death, and undertreated pain. By optimizing post-operative pain management protocols, the need for opioids following sinus surgery should be minimized.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Sinus; Inflammation, Opioid Abuse, Pain, Postoperative
Keywords
NSAIDs, post-operative pain, post-operative hemorrhage, Functional endoscopic sinus surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
prospective, cohort study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Tylenol Regimen
Arm Type
Other
Arm Description
Patient will be given a standard regimen: Tylenol 1000 mg by mouth every 6 hours scheduled and a rescue prescription of oxycodone 5 mg tablets by mouth every 6 hours as needed for pain. Ten total oxycodone tablets will be prescribed.
Arm Title
Ibuprofen 600mg
Arm Type
Active Comparator
Arm Description
Tylenol 1000 mg by mouth every 6 hours scheduled and ibuprofen 600 mg tablet by mouth every 8 hours scheduled and a rescue prescription of oxycodone 5 mg tablets by mouth every 6 hours as needed for pain. Ten total oxycodone tablets will be prescribed.
Intervention Type
Drug
Intervention Name(s)
Ibuprofen 600Mg Tablet
Other Intervention Name(s)
Advil, Motrin IB
Intervention Description
ibuprofen 600 mg by mouth every 8 hours scheduled in addition to standard tylenol regimen.
Intervention Type
Other
Intervention Name(s)
Standard Regimen | Tylenol
Other Intervention Name(s)
Acetaminophen
Intervention Description
Tylenol 1000 mg by mouth every 6 hours scheduled and a rescue prescription of oxycodone 5 mg tablets by mouth every 6 hours as needed for pain. Ten total oxycodone tablets will be prescribed.
Primary Outcome Measure Information:
Title
Pain level
Description
Patients will be given a Visual Analogue scale to help document their level of pain from Post-operative days 0, 1, 2, 3, 4 ,5 and the first post-operative visit with the surgeon. The patient will measure their pain score each time they take medication. The pain scale called the Wong-Baker FACES pain rating scale is a 0-10 pain scale. 0 = no hurt, 2 = hurts little bit, 4 = hurts little more, 6 = hurts even more, 8 = hurts whole lot, 10 = hurts worst. The numbers are added up to a sum and put into their perspective category known by the Otolaryngologist.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Rate of bleeding
Description
Any physician visits secondary to bleeding will be tabulated including ER and office visits.
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • All patients age 18-65 undergoing functional endoscopic sinus surgery +/- nasal airway surgery (septoplasty and/or inferior turbinate reduction). Exclusion Criteria: Not taking anti-coagulation medications including aspirin Clinical Diagnosis of aspirin-exacerbated respiratory disease Clinical Diagnosis of Cystic Fibrosis Clinical Diagnosis of Primary Ciliary Dyskinesia Inclusion of a Draf III frontal sinusotomy Clinical Diagnosis of Liver/Kidney Failure Clinical Diagnosis of Thrombocytopenia Clinical Diagnosis of Poorly controlled hypertension Clinical Diagnosis of Recent GI ulcers or gastritis Clinical Diagnosis of Chronic pain as defined by a narcotic prescription with 6 months or involvement in a pain management program Clinical Diagnosis of Primary Headache disorder The use of nasal decongestants in the post-operative period. The use of nasal packing or absorbable biomaterials.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christie Barnes, MD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0528
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Pain Management Following Sinus Surgery

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