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Completed

NCT Number: NCT03584152

Postoperative Pain Management in Rhinoplasty

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Facial Plastic and Reconstructive Surgery Clinic

Stanford, California, 94305, United States

About this study

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

  • Is adequate postoperative pain management after nasal surgery achieved with opioid or non-opioid drugs?
  • If opioid drugs are required for adequate pain control postoperatively, is it possible to reduce the number of days the drugs are prescribed for?
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Norco 5Mg-325Mg Tablet

Drug

Opioid Analgesics

Other names: Lortab, Vicodin, Hycet

Tylenol 325Mg Caplet

Drug

Non opioid analgesics

Other names: Acetaminophen

Ibuprofen 200 mg

Drug

Non opioid analgesics

Other names: Advil, Motrin

Primary outcomes

  1. 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.

Secondary outcomes

  1. Number of Study Drugs (Doses) Utilized

    Time frame: 5 days

    Use of any study medication, excluding tramadol.

  2. Number of Tramadol Doses Utilized

    Time frame: 5 days

  3. Number Patients Who Reported Adequate Pain Control

    Time frame: 5 days

  4. 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. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Postoperative Pain Management in Rhinoplasty: A Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Jul 12, 2018
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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