Postoperative Pain Management in Rhinoplasty

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: Active, not recruiting
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Norco 5Mg-325Mg Tablet; Drug: Tylenol 325Mg Caplet; Drug: Ibuprofen 200 mg

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 (Estimated): 51
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

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 - FACE (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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DRUG ARM A; Norco 5Mg-325Mg 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 325Mg 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)	Self reported pain intensity at every prescribed dose for a period of 5 days.	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects of pain medications	Self reported side effects of prescribed medications	5 days

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2019
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): December 1, 2024

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 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Postoperative pain; Rhinoplasty
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Ibuprofen
• 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