Clinical trial NCT03584152: Postoperative Pain Management in Rhinoplasty
Official title: Postoperative Pain Management in Rhinoplasty: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Pain, Postoperative
Keywords: Postoperative pain
Rhinoplasty
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-07-12
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary purpose of the study is to determine adequacy of postoperative pain control after nasal surgery in patients prescribed Acetaminophen (325mg) + Hydrocodone (5mg) compared to Acetaminophen(325mg) + Ibuprofen (200mg)for a period of 5 days after nasal surgery. To assess the degree of pain, the participants will score the intensity of their pain on a visual analog scale(VAS)of 0-100points (0- no pain and 100- most severe pain), preoperatively and postoperatively (to be documented before each dose) for the duration of the prescribed medications .

Additionally, the study will also seek to track:

1. The total number of pills each patients consume from the prescribed 5 day regimen.
2. Any associated side effects.
3. Additional pain medications prescribed in case of inadequate pain control, postoperatively.

Detailed description: From this study, the investigators hope to learn the following:

1. Is adequate postoperative pain management after nasal surgery achieved with opioid or non-opioid drugs?
2. If opioid drugs are required for adequate pain control postoperatively, is it possible to reduce the number of days the drugs are prescribed for?
3. What are the common side effect profiles of the included drugs?

In light of the current opioid epidemic in the country, it is important the the physicians explore the utility of drugs other than opioids for adequate postoperative pain management. Also, reducing the dosage and/or number of prescribed opioid drugs lessens the propensity for misuse of physician prescribed opioid medications.

Eligibility criteria: Inclusion Criteria:

* Minimum age of 18 years
* Able to speak and understand english.
* Undergoing rhinoplasty for cosmetic purposes
* Undergoing rhinoplasty for treatment of nasal obstruction

Exclusion Criteria:

* Less than 18 years of age
* Cannot speak and understand english
* Patients who have undergone nasal surgery in the past
* Patients not undergoing nasal surgery
* Women will be excluded if they are either pregnant or lactating as this population does not undergo nasal surgery at our center.
* Patients with any known allergies to the class of pain medications used in the study.

Please note: Any person interested in this clinical trial should contact the Facial Plastic and Reconstructive Surgery clinic at (650) 736 - 3223 to schedule a consultation with Dr. Sam P. Most to assess their eligibility for the trial. Please note, enrolling in the clinical trial will not entitle the participant to a waiver of charges associated with undergoing nasal surgery.

Primary outcomes:
measure: Pain intensity Visual Analog Scale (VAS)- 0-100 (0- no pain and 100- most severe pain)
timeFrame: 5 days
Secondary outcomes:
measure: Side effects of pain medications
timeFrame: 5 days
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Facial Plastic and Reconstructive Surgery Clinic
state: California
Study officials:
affiliation: Stanford University
name: SAM P Most, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patel S, Sturm A, Bobian M, Svider PF, Zuliani G, Kridel R. Opioid Use by Patients After Rhinoplasty. JAMA Facial Plast Surg. 2018 Jan 1;20(1):24-30. doi: 10.1001/jamafacial.2017.1034.