Pain Management Following Sinus Surgery

Post-operative Pain Management Following Functional Endoscopic Sinus Surgery

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.

Study Overview

• Status: Terminated
• Conditions: Pain, Postoperative; Opioid Abuse; Nasal Sinus; Inflammation
• Intervention / Treatment: Other: Standard Regimen | Tylenol; Drug: Ibuprofen 600Mg Tablet

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45267-0528
      • University of Cincinnati

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard Tylenol Regimen; 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.	Other: Standard Regimen | Tylenol; 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.; Other Names: Acetaminophen
Active Comparator: Ibuprofen 600mg; 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.	Other: Standard Regimen | Tylenol; 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.; Other Names: Acetaminophen; Drug: Ibuprofen 600Mg Tablet; ibuprofen 600 mg by mouth every 8 hours scheduled in addition to standard tylenol regimen.; Other Names: Advil, Motrin IB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of bleeding	Any physician visits secondary to bleeding will be tabulated including ER and office visits.	1 week

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Christie Barnes, MD, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2020
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: January 28, 2019
• First Submitted That Met QC Criteria: January 28, 2019
• First Posted (Actual): January 30, 2019

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: post-operative pain; NSAIDs; Functional endoscopic sinus surgery; post-operative hemorrhage
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Substance-Related Disorders; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Narcotic-Related Disorders; Pain, Postoperative; Inflammation; Sinusitis; Opioid-Related Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Ibuprofen
• Other Study ID Numbers: 0417-18-FB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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