Clinical trial NCT03822962: Pain Management Following Sinus Surgery
Official title: Post-operative Pain Management Following Functional Endoscopic Sinus Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Nasal Sinus; Inflammation
Opioid Abuse
Pain, Postoperative
Keywords: NSAIDs
post-operative pain
post-operative hemorrhage
Functional endoscopic sinus surgery
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, cohort study
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain level
timeFrame: 1 week
Secondary outcomes:
measure: Rate of bleeding
timeFrame: 1 week
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Nebraska
name: Christie Barnes, MD
role: PRINCIPAL_INVESTIGATOR
References: