Pain Management Following Sinus Surgery

Pain, Postoperative Clinical Trial

Official title:

Post-operative Pain Management Following Functional Endoscopic Sinus Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03822962
• Other study ID #: 0417-18-FB
• Status: Terminated
• Phase: Early Phase 1
• Start date: November 7, 2020
• Est. completion date: May 30, 2023

Study information

• Verified date: August 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: May 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation
• Nasal Sinus; Inflammation
• Opioid Abuse
• Opioid-Related Disorders
• Pain, Postoperative
• Sinusitis

Intervention

Drug:
• Ibuprofen 600Mg Tablet
ibuprofen 600 mg by mouth every 8 hours scheduled in addition to standard tylenol regimen.

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.

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of bleeding	Any physician visits secondary to bleeding will be tabulated including ER and office visits.	1 week