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Postoperative Pain Management in Rhinoplasty

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ClinicalTrials.gov Identifier: NCT03584152
Recruitment Status : Enrolling by invitation
First Posted : July 12, 2018
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Sam P. Most, Stanford University

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. 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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Norco 5Mg-325Mg Tablet Drug: Tylenol 325Mg Caplet Drug: Ibuprofen 200 mg Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Postoperative Pain Management in Rhinoplasty: A Randomized Controlled Trial
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ibuprofen

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:
  • Lortab
  • Vicodin
  • Hycet

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 Name: Acetaminophen

Drug: Ibuprofen 200 mg
Non opioid analgesics
Other Names:
  • Advil
  • Motrin




Primary Outcome Measures :
  1. Pain intensity Visual Analog Scale (VAS)- 0-100 (0- no pain and 100- most severe pain) [ Time Frame: 5 days ]
    Self reported pain intensity at every prescribed dose for a period of 5 days.


Secondary Outcome Measures :
  1. Side effects of pain medications [ Time Frame: 5 days ]
    Self reported side effects of prescribed medications



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584152


Locations
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United States, California
Facial Plastic and Reconstructive Surgery Clinic
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: SAM P Most, MD Stanford University

Publications of Results:
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Responsible Party: Sam P. Most, Chief, Division of Facial Plastic and Reconstructive Surgery, Stanford University
ClinicalTrials.gov Identifier: NCT03584152     History of Changes
Other Study ID Numbers: 46945
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Sam P. Most, Stanford University:
Postoperative pain
Rhinoplasty

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Ibuprofen
Acetaminophen, hydrocodone drug combination
Hydrocodone
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents