Postoperative Pain Management in Rhinoplasty

Pain, Postoperative Clinical Trial

Official title:

Postoperative Pain Management in Rhinoplasty: A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03584152
• Other study ID #: 46945
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 9, 2019
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 51
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Norco 5Mg-325Mg Tablet
Opioid Analgesics
• Tylenol 325Mg Caplet
Non opioid analgesics
• Ibuprofen 200 mg
Non opioid analgesics

Locations

Country	Name	City	State
United States	Facial Plastic and Reconstructive Surgery Clinic	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Side effects of pain medications	Self reported side effects of prescribed medications	5 days