Postoperative Pain Management in Rhinoplasty

November 24, 2025 updated by: Sam P. Most, Stanford University

Postoperative Pain Management in Rhinoplasty: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

159

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Facial Plastic and Reconstructive Surgery Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Drug Arm A
Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total
Drug: Norco 5Mg-325Mg Tablet
Opioid Analgesics
Other Names:
  • Vicodin
  • Hycet
  • Lortab
Active Comparator: Drug Arm B
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
Non opioid analgesics
Other Names:
  • Acetaminophen
Drug: Ibuprofen 200 mg
Non opioid analgesics
Other Names:
  • Advil
  • Motrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity Visual Analog Scale (VAS)- 0-100 (0- no Pain and 100- Most Severe Pain)
Time Frame: 5 days post-operative [up to approximately 5 weeks post-baseline]
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Study Drugs (Doses) Utilized
Time Frame: 5 days
Use of any study medication, excluding tramadol.
5 days
Number of Tramadol Doses Utilized
Time Frame: 5 days
5 days
Number Patients Who Reported Adequate Pain Control
Time Frame: 5 days
5 days
Side Effects of Pain Medications
Time Frame: 5 days
Self reported side effects of prescribed medications according to response options. Participants may have reported more than one side-effect. Commonly experienced medication side-effects would not necessarily be considered to be adverse events.
5 days
Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) Questionnaire
Time Frame: Baseline and post-operative follow-up (up to an average of 12 months following procedure)
The SCHNOS-O (obstructive) and SCHNOS-C (Cosmesis) scores were rated from 0 to 100 (higher scores correspond to worse obstruction or cosmesis). Not all 130 patients had a postoperative score at both time follow-up intervals (<6 months, and ≥ 6 months, obtained by chart review), thus a mean postoperative score (SD) was calculated for each treatment group accounting for both intervals.
Baseline and post-operative follow-up (up to an average of 12 months following procedure)
Visual Analog Scale-Functional (VAS-F)
Time Frame: Baseline and post-operative follow-up (up to an average of 12 months following procedure)
Patient's perceived severity of their nasal obstruction was self-graded using a 10-cm-long visual analogue scale ('0' indicated 'no nasal obstruction' and '10' indicated 'worst possible nasal obstruction). Not all 130 patients had a postoperative score at both time follow-up intervals (<6 months, and ≥ 6 months, obtained by chart review), thus a mean postoperative score (SD) was calculated for each treatment group accounting for both intervals.
Baseline and post-operative follow-up (up to an average of 12 months following procedure)
Visual Analog Scale-Aesthetic (VAS-A)
Time Frame: Baseline and post-operative follow-up (up to an average of 12 months following procedure)
Patient's perceived aesthetic appearance was self-graded using a 10-cm-long visual analogue scale ('0' indicated 'completely dissatisfied with nasal appearance' and '10' indicated 'the highest possible satisfaction with nasal appearance'). Not all 130 patients had a postoperative score at both time follow-up intervals (<6 months, and ≥ 6 months, obtained by chart review), thus a mean postoperative score (SD) was calculated for each treatment group accounting for both intervals.
Baseline and post-operative follow-up (up to an average of 12 months following procedure)
Eyelid Edema Score
Time Frame: Post-operative day 7
Physician-assessed grading of eyelid edema. Score range: 0 to 4; higher numbers indicating more severe swelling.
Post-operative day 7
Ecchymosis Score
Time Frame: Post-operative day 7
Physician-assessed grading of periorbital ecchymosis extension. Score range: 0 to 4; higher numbers indicating more severe ecchymosis.
Post-operative day 7
Subconjunctival Hemorrhage Score
Time Frame: Post-operative day 7
Physician-assessed grading of subconjunctival hemorrhage. Score range: 0 to 2; higher numbers indicating more severe hemorrhage.
Post-operative day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: SAM P Most, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2019

Primary Completion (Actual)

November 14, 2024

Study Completion (Actual)

July 17, 2025

Study Registration Dates

First Submitted

June 27, 2018

First Submitted That Met QC Criteria

July 10, 2018

First Posted (Actual)

July 12, 2018

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

November 24, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 46945

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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