Narcotics vs NSAIDs for Post-operative Analgesia in Outpatient Rhinoplasty

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT03457116
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Actual Duration (Months): 33.1
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the efficacy and safety of oral opiate pain medication vs non-steroidal ant inflammatory drugs (NSAIDs) in the treatment of postoperative rhinoplasty pain. This study will also evaluate potential contributing factors affecting the efficacy of these pain control methods. Patients will be randomized to receive either NSAIDs in the form of 400mg of Ibuprofen or Norco (hydrocodone 5mg- acetaminophen 325mg) to be used for post-operative pain. The study will then compare which is more effective in controlling post operative pain.

Condition or Disease	Intervention/Treatment	Phase
Rhinoplasty; Non-steroidal Ant Inflammatory Drugs; Opioid Use	Drug: Norco; Drug: NSAID	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Narcotics vs Non-steroidal Ant Inflammatory Drugs Post-operative Analgesia in Outpatient Rhinoplasty
• Actual Study Start Date: Jan 30, 2018
• Actual Primary Completion Date: Nov 2, 2020
• Actual Study Completion Date: Nov 2, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: NSAIDS 400mg of Ibuprofen	Drug: NSAID; Ibuprofen 400mg for post-operative pain
Active Comparator: Opiates Norco (hydrocodone 5mg- acetaminophen 325mg)	Drug: Norco; 20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco)

Outcome Measures

Primary Outcome Measures

1. Average Pain Score [Day 0]

   Pain scores are reported via Post-Operative Pain Management Survey. On a scale of 1-10, participants indicate how much pain they were in on their pain regiment. The higher the score, the worse the pain (1 = no pain, 10 = worst pain possible)

2. Average Pain Score [Day 1]

   Pain scores are reported via Post-Operative Pain Management Survey. On a scale of 1-10, participants indicate how much pain they were in on their pain regiment. The higher the score, the worse the pain (1 = no pain, 10 = worst pain possible)

3. Average Pain Score [Day 7]

   Pain scores are reported via Post-Operative Pain Management Survey. On a scale of 1-10, participants indicate how much pain they were in on their pain regiment. The higher the score, the worse the pain (1 = no pain, 10 = worst pain possible)

4. Average Post-Operative Day (POD) of Medication Cessation [Day 7]

   Self-reported via Post-Operative Pain Management Survey

Secondary Outcome Measures

1. Number of Participants in NSAIDs Group Who Were Upgraded to Opiates Due to High Levels of Pain [Day 7]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients 18-70 years old undergoing septorhinoplasty or rhinoplasty for either obstructive or aesthetic reasons. All approaches to rhinoplasty and surgical techniques utilized will be included. This will include patients that undergo additional procedures during the rhinoplasty including osteotomies, turbinate reduction, septoplasty, nasal valve repair and ear cartilage graft.

Exclusion Criteria:

• Patients who undergo a rhinoplasty requiring a rib cartilage graft for the procedure as this is known to cause significant pleuritic chest pain.

• Patients receiving functional endoscopic sinus surgery concurrently with the rhinoplasty will be excluded.

• Patients with known history of gastrointestinal bleeds, peptic ulcer disease or who have other comorbidities that prevent them from taking NSAIDs.

• Patients with a history of radiation, active head and neck malignancy or other pain disorders such as various rheumatologic diseases will be excluded to decrease confounding factors in the control of pain.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Langone Medical Center	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: Judy Lee, MD, NYU Langone

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 17, 2018

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT03457116
• Other Study ID Numbers: 17-01839
• First Posted: Mar 7, 2018
• Last Update Posted: Nov 23, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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.: No

Study Results

Participant Flow

Arm/Group Title	NSAIDS	Opiates
Arm/Group Description	400mg of Ibuprofen NSAID: Ibuprofen 400mg for post-operative pain	Norco (hydrocodone 5mg- acetaminophen 325mg) Norco: 20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco)
Period Title: Overall Study
STARTED	41	29
COMPLETED	41	29
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	NSAIDS	Opiates	Total
Arm/Group Description	400mg of Ibuprofen NSAID: Ibuprofen 400mg for post-operative pain	Norco (hydrocodone 5mg- acetaminophen 325mg) Norco: 20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco)	Total of all reporting groups
Overall Participants	41	29	70
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	32	32	32
Sex: Female, Male (Count of Participants)
Female	19 46.3%	12 41.4%	31 44.3%
Male	22 53.7%	17 58.6%	39 55.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	41 100%	29 100%	70 100%

Outcome Measures

1. Primary Outcome

Title	Average Pain Score
Description	Pain scores are reported via Post-Operative Pain Management Survey. On a scale of 1-10, participants indicate how much pain they were in on their pain regiment. The higher the score, the worse the pain (1 = no pain, 10 = worst pain possible)
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NSAIDS	Opiates
Arm/Group Description	400mg of Ibuprofen NSAID: Ibuprofen 400mg for post-operative pain	Norco (hydrocodone 5mg- acetaminophen 325mg) Norco: 20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco)
Measure Participants	41	29
Mean (Standard Deviation) [score on a scale]	2.54 (1.57)	3.14 (1.75)

2. Primary Outcome

Title	Average Pain Score
Description	Pain scores are reported via Post-Operative Pain Management Survey. On a scale of 1-10, participants indicate how much pain they were in on their pain regiment. The higher the score, the worse the pain (1 = no pain, 10 = worst pain possible)
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NSAIDS	Opiates
Arm/Group Description	400mg of Ibuprofen NSAID: Ibuprofen 400mg for post-operative pain	Norco (hydrocodone 5mg- acetaminophen 325mg) Norco: 20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco)
Measure Participants	41	29
Mean (Standard Deviation) [score on a scale]	1.84 (1.29)	2.46 (1.90)

3. Primary Outcome

Title	Average Pain Score
Description	Pain scores are reported via Post-Operative Pain Management Survey. On a scale of 1-10, participants indicate how much pain they were in on their pain regiment. The higher the score, the worse the pain (1 = no pain, 10 = worst pain possible)
Time Frame	Day 7

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NSAIDS	Opiates
Arm/Group Description	400mg of Ibuprofen NSAID: Ibuprofen 400mg for post-operative pain	Norco (hydrocodone 5mg- acetaminophen 325mg) Norco: 20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco)
Measure Participants	41	29
Mean (Standard Deviation) [score on a scale]	3.29 (2.14)	3.14 (2.12)

4. Primary Outcome

Title	Average Post-Operative Day (POD) of Medication Cessation
Description	Self-reported via Post-Operative Pain Management Survey
Time Frame	Day 7

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NSAIDS	Opiates
Arm/Group Description	400mg of Ibuprofen NSAID: Ibuprofen 400mg for post-operative pain	Norco (hydrocodone 5mg- acetaminophen 325mg) Norco: 20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco)
Measure Participants	41	29
Mean (Standard Deviation) [days]	4.73 (1.57)	4.28 (2.23)

5. Secondary Outcome

Title	Number of Participants in NSAIDs Group Who Were Upgraded to Opiates Due to High Levels of Pain
Time Frame	Day 7

Outcome Measure Data

Analysis Population Description

This outcome measure is only applicable to NSAIDS

Arm/Group Title	NSAIDS
Arm/Group Description	400mg of Ibuprofen NSAID: Ibuprofen 400mg for post-operative pain
Measure Participants	41
Count of Participants [Participants]	5 12.2%

Adverse Events

Time Frame	7 days
Arm/Group Title	NSAIDS		Opiates
Arm/Group Description	400mg of Ibuprofen NSAID: Ibuprofen 400mg for post-operative pain		Norco (hydrocodone 5mg- acetaminophen 325mg) Norco: 20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco)
All Cause Mortality
	NSAIDS		Opiates
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/29 (0%)
Serious Adverse Events
	NSAIDS		Opiates
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/29 (0%)
Other (Not Including Serious) Adverse Events
	NSAIDS		Opiates
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/29 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.