Postoperative Pain Management in Rhinoplasty

NCT03584152 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 46945
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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

Conditions

Pain, Postoperative

Keywords

Postoperative pain; Rhinoplasty

Outcome Measures

Primary Outcomes (1)

• Pain Intensity Visual Analog Scale (VAS)- 0-100 (0- no Pain and 100- Most Severe Pain)

  Self reported pain intensity at every prescribed dose averaged over a period of 5 days.

  5 days post-operative [up to approximately 5 weeks post-baseline]

Secondary Outcomes (10)

• Number of Study Drugs (Doses) Utilized

  5 days

• Number of Tramadol Doses Utilized

  5 days

• Number Patients Who Reported Adequate Pain Control

  5 days

• Side Effects of Pain Medications

  5 days

• Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) Questionnaire

  Baseline and post-operative follow-up (up to an average of 12 months following procedure)

Study Arms (2)

Drug Arm A

ACTIVE COMPARATOR

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

Drug: Norco 5Mg-325Mg Tablet

Drug Arm B

ACTIVE COMPARATOR

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.

Drug: Tylenol 325Mg Caplet; Drug: Ibuprofen 200 mg

Interventions

Tylenol 325Mg Caplet DRUG

Non opioid analgesics

Also known as: Acetaminophen

Drug Arm B

Ibuprofen 200 mg DRUG

Non opioid analgesics

Also known as: Advil, Motrin

Drug Arm B

Norco 5Mg-325Mg Tablet DRUG

Opioid Analgesics

Also known as: Lortab, Vicodin, Hycet

Drug Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Facial Plastic and Reconstructive Surgery Clinic

Stanford, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 29121158 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

oxycodone-acetaminophen; acetaminophen, hydrocodone drug combination; Acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Results Point of Contact

• Title: Sam P. Most, MD, MBA
• Organization: Stanford University

smost@stanford.edu

(650) 724-8019

Study Officials

• SAM P Most, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Facial Plastic and Reconstructive Surgery

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: July 12, 2018
• Study Start: August 9, 2019
• Primary Completion: November 14, 2024
• Study Completion: July 17, 2025
• Last Updated: December 3, 2025
• Results First Posted: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)