Multimodal Analgesia With Acetaminophen vs. Narcotics Alone After Hip Arthroscopy

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT03510910
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Months): 19.7
• Patients Per Site Per Month: 5.1

Study Details

Study Description

Brief Summary

The purpose of this proposed study is to evaluate the efficacy of a multimodal approach to analgesia for patient's pain after hip arthroscopy and to also assess if this new approach will result in a reduction in post-operative narcotic use.

This study is a single-center, randomized prospective study comparing post-operative pain scores and narcotic consumption between individuals receiving acetaminophen along with a reduced quantity of Percocet (to be used as needed for breakthrough pain) and individuals receiving Percocet only. Both pain management options are considered to be standard of care. Both cohorts will receive aspirin for DVT prophylaxis and celecoxib for heterotopic ossification prophylaxis.

The primary objective of the study are to compare patients' narcotic consumption and reported pain following arthroscopic hip surgery, and determine if acetaminophen can provide adequate pain relief compared to a narcotic medication.

Condition or Disease	Intervention/Treatment	Phase
Hip Arthroscopy	Drug: Acetaminophen; Drug: Percocet	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Multimodal Analgesia With Acetaminophen vs. Narcotics Alone After Hip Arthroscopy
• Actual Study Start Date: Apr 10, 2018
• Actual Primary Completion Date: Dec 1, 2019
• Actual Study Completion Date: Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Acetaminophen along with a reduced quantity of Percocet	Drug: Acetaminophen; acetaminophen 600 mg to be taken every 8 hours (TID); Drug: Percocet; Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group. Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN
Experimental: Percocet only	Drug: Percocet; Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group. Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN

Outcome Measures

Primary Outcome Measures

1. Patient Satisfaction [7 days post-surgery]

   Satisfaction was reported on a Likert-type scale of 1-10 (the higher the score, the higher the satisfaction)

2. Morphine-equivalent Consumption [7 days post-surgery]

   Amount of oxycodone/acetaminophen (Percocet) in 5mg/325mg doses will be recorded in number of pills

3. Score on Visual Analog Scale (VAS) of Pain [24 hours post-surgery]

   Pain severity scores at rest will be assessed by use of VAS. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." The higher the score, the worse the pain.

4. Score on Visual Analog Scale (VAS) of Pain [4 days post-surgery]

   Pain severity scores at rest will be assessed by use of VAS. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." The higher the score, the worse the pain.

5. Score on Visual Analog Scale (VAS) of Pain [7 days post-surgery]

   Pain severity scores at rest will be assessed by use of VAS. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." The higher the score, the worse the pain.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• ASA class I-II

• Patients indicated and scheduled for arthroscopic hip surgery

Exclusion Criteria:

• Contraindication to acetaminophen or oxycodone/acetaminophen (e.g. hypersensitivity, history of GI or bleeding disorder)

• Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia, etc.)

• Younger than 18 years of age or older than 65

• Any patient considered a vulnerable subject

• Patients on pain medication prior to surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: Thomas Youm, MD, NYU Langone Health

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 15, 2018

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT03510910
• Other Study ID Numbers: 18-00167
• First Posted: Apr 27, 2018
• Last Update Posted: Jan 7, 2021
• Last Verified: Dec 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acetaminophen

Study Results

Participant Flow

Arm/Group Title	Acetaminophen Along With a Reduced Quantity of Percocet	Percocet Only
Arm/Group Description	Acetaminophen: acetaminophen 600 mg to be taken every 8 hours (TID) Percocet: Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group. Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN	Percocet: Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group. Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN
Period Title: Overall Study
STARTED	42	43
COMPLETED	40	40
NOT COMPLETED	2	3

Baseline Characteristics

Arm/Group Title	Acetaminophen Along With a Reduced Quantity of Percocet	Percocet Only	Total
Arm/Group Description	Acetaminophen: acetaminophen 600 mg to be taken every 8 hours (TID) Percocet: Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group. Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN	Percocet: Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group. Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN	Total of all reporting groups
Overall Participants	40	40	80
Age (years) [Median (Standard Deviation) ]
Median (Standard Deviation) [years]	39.43 (13.1)	40.2 (16.5)	39.82 (14.8)
Sex: Female, Male (Count of Participants)
Female	24 60%	22 55%	46 57.5%
Male	16 40%	18 45%	34 42.5%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	40 100%	40 100%	80 100%

Outcome Measures

1. Primary Outcome

Title	Patient Satisfaction
Description	Satisfaction was reported on a Likert-type scale of 1-10 (the higher the score, the higher the satisfaction)
Time Frame	7 days post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acetaminophen Along With a Reduced Quantity of Percocet	Percocet Only
Arm/Group Description	Acetaminophen: acetaminophen 600 mg to be taken every 8 hours (TID) Percocet: Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group. Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN	Percocet: Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group. Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN
Measure Participants	40	40
Mean (Standard Deviation) [score on a scale]	8.48 (1.52)	8.83 (1.55)

2. Primary Outcome

Title	Morphine-equivalent Consumption
Description	Amount of oxycodone/acetaminophen (Percocet) in 5mg/325mg doses will be recorded in number of pills
Time Frame	7 days post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acetaminophen Along With a Reduced Quantity of Percocet	Percocet Only
Arm/Group Description	Acetaminophen: acetaminophen 600 mg to be taken every 8 hours (TID) Percocet: Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group. Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN	Percocet: Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group. Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN
Measure Participants	40	40
Mean (Standard Deviation) [pills]	6.33 (7.1)	5.69 (5.8)

3. Primary Outcome

Title	Score on Visual Analog Scale (VAS) of Pain
Description	Pain severity scores at rest will be assessed by use of VAS. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." The higher the score, the worse the pain.
Time Frame	24 hours post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acetaminophen Along With a Reduced Quantity of Percocet	Percocet Only
Arm/Group Description	Acetaminophen: acetaminophen 600 mg to be taken every 8 hours (TID) Percocet: Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group. Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN	Percocet: Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group. Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN
Measure Participants	40	40
Mean (Standard Deviation) [score on a scale]	5.30 (2.02)	4.98 (2.24)

4. Primary Outcome

Title	Score on Visual Analog Scale (VAS) of Pain
Description	Pain severity scores at rest will be assessed by use of VAS. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." The higher the score, the worse the pain.
Time Frame	4 days post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acetaminophen Along With a Reduced Quantity of Percocet	Percocet Only
Arm/Group Description	Acetaminophen: acetaminophen 600 mg to be taken every 8 hours (TID) Percocet: Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group. Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN	Percocet: Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group. Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN
Measure Participants	40	40
Mean (Standard Deviation) [score on a scale]	3.55 (1.68)	3.20 (1.98)

5. Primary Outcome

Title	Score on Visual Analog Scale (VAS) of Pain
Description	Pain severity scores at rest will be assessed by use of VAS. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." The higher the score, the worse the pain.
Time Frame	7 days post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acetaminophen Along With a Reduced Quantity of Percocet	Percocet Only
Arm/Group Description	Acetaminophen: acetaminophen 600 mg to be taken every 8 hours (TID) Percocet: Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group. Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN	Percocet: Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group. Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN
Measure Participants	40	40
Mean (Standard Deviation) [score on a scale]	3.20 (1.79)	2.83 (2.11)

Adverse Events

Time Frame	6 months
Arm/Group Title	Acetaminophen Along With a Reduced Quantity of Percocet		Percocet Only
Arm/Group Description	Acetaminophen: acetaminophen 600 mg to be taken every 8 hours (TID) Percocet: Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group. Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN		Percocet: Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group. Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN
All Cause Mortality
	Acetaminophen Along With a Reduced Quantity of Percocet		Percocet Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)
Serious Adverse Events
	Acetaminophen Along With a Reduced Quantity of Percocet		Percocet Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	Acetaminophen Along With a Reduced Quantity of Percocet		Percocet Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (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.