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Postoperative Pain Management in Rhinoplasty

Primary Purpose

Pain, Postoperative

Status

Enrolling by invitation

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Norco 5Mg-325Mg Tablet

Tylenol 325Mg Caplet

Ibuprofen 200 mg

About this trial

This is an interventional supportive care trial for Pain, Postoperative focused on measuring Postoperative pain, Rhinoplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Facial Plastic and Reconstructive Surgery Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

DRUG ARM A

DRUG ARM B

Arm Description

Norco 5Mg-325Mg Tablet, administered orally every 4 hours for 5 days total

Tylenol 325Mg Caplet, administered orally every 4 hours for 5 days total. Ibuprofen 200 mg administered orally every 4 hours for 5 days total.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Side effects of pain medications

Self reported side effects of prescribed medications

Full Information

NCT ID

NCT03584152

First Posted

June 27, 2018

Last Updated

May 5, 2022

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT03584152

Brief Title

Postoperative Pain Management in Rhinoplasty

Official Title

Postoperative Pain Management in Rhinoplasty: A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Enrolling by invitation

Study Start Date

August 9, 2019 (Actual)

Primary Completion Date

August 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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: The total number of pills each patients consume from the prescribed 5 day regimen. Any associated side effects. Additional pain medications prescribed in case of inadequate pain control, postoperatively.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative

Keywords

Postoperative pain, Rhinoplasty

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

51 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DRUG ARM A

Arm Type

Active Comparator

Arm Description

Norco 5Mg-325Mg Tablet, administered orally every 4 hours for 5 days total

Arm Title

DRUG ARM B

Arm Type

Active Comparator

Arm Description

Tylenol 325Mg Caplet, administered orally every 4 hours for 5 days total. Ibuprofen 200 mg administered orally every 4 hours for 5 days total.

Intervention Type

Drug

Intervention Name(s)

Norco 5Mg-325Mg Tablet

Other Intervention Name(s)

Lortab, Vicodin, Hycet

Intervention Description

Opioid Analgesics

Intervention Type

Drug

Intervention Name(s)

Tylenol 325Mg Caplet

Other Intervention Name(s)

Acetaminophen

Intervention Description

Non opioid analgesics

Intervention Type

Drug

Intervention Name(s)

Ibuprofen 200 mg

Other Intervention Name(s)

Advil, Motrin

Intervention Description

Non opioid analgesics

Primary Outcome Measure Information:

Title

Pain intensity Visual Analog Scale (VAS)- 0-100 (0- no pain and 100- most severe pain)

Description

Self reported pain intensity at every prescribed dose for a period of 5 days.

Time Frame

5 days

Secondary Outcome Measure Information:

Title

Side effects of pain medications

Description

Self reported side effects of prescribed medications

Time Frame

5 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

SAM P Most, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Facial Plastic and Reconstructive Surgery Clinic

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29121158

Citation

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.

Results Reference

result

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Postoperative Pain Management in Rhinoplasty

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