Postoperative Pain Management in Rhinoplasty

Stanford University

Status and phase: Completed; Phase 2

Conditions: Pain, Postoperative

Treatments: Drug: Norco 5Mg-325Mg Tablet; Drug: Ibuprofen 200 mg; Drug: Tylenol 325Mg Caplet

Study type: Interventional

Funder types: Other

Identifiers

NCT03584152

46945

Details and patient eligibility

About

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.

Full 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.

Enrollment: 159 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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159 participants in 2 patient groups

Drug Arm A

Active Comparator group

Description:

Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total

Treatment:

Drug: Norco 5Mg-325Mg Tablet

Drug Arm B

Active Comparator group

Description:

Tylenol 325 mg Caplet, administered orally every 4 hours for 5 days total. Ibuprofen 200 mg administered orally every 4 hours for 5 days total.

Treatment:

Drug: Tylenol 325Mg Caplet

Drug: Ibuprofen 200 mg