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Multimodal Analgesia With Acetaminophen vs. Narcotics Alone After Hip Arthroscopy

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ClinicalTrials.gov Identifier: NCT03510910
Recruitment Status : Completed
First Posted : April 27, 2018
Results First Posted : January 7, 2021
Last Update Posted : January 7, 2021
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hip Arthroscopy
Interventions Drug: Acetaminophen
Drug: Percocet
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Acetaminophen Along With a Reduced Quantity of Percocet Percocet Only
Hide 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
Reason Not Completed
Incomplete Survey             2             3
Arm/Group Title Acetaminophen Along With a Reduced Quantity of Percocet Percocet Only Total
Hide 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 Number of Baseline Participants 40 40 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 80 participants
39.43  (13.1) 40.2  (16.5) 39.82  (14.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Female
24
  60.0%
22
  55.0%
46
  57.5%
Male
16
  40.0%
18
  45.0%
34
  42.5%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants 40 participants 80 participants
40 40 80
1.Primary Outcome
Title Patient Satisfaction
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Along With a Reduced Quantity of Percocet Percocet Only
Hide 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

Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: score on a scale
8.48  (1.52) 8.83  (1.55)
2.Primary Outcome
Title Morphine-equivalent Consumption
Hide Description Amount of oxycodone/acetaminophen (Percocet) in 5mg/325mg doses will be recorded in number of pills
Time Frame 7 days post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Along With a Reduced Quantity of Percocet Percocet Only
Hide 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

Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: pills
6.33  (7.1) 5.69  (5.8)
3.Primary Outcome
Title Score on Visual Analog Scale (VAS) of Pain
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Along With a Reduced Quantity of Percocet Percocet Only
Hide 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

Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: score on a scale
5.30  (2.02) 4.98  (2.24)
4.Primary Outcome
Title Score on Visual Analog Scale (VAS) of Pain
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Along With a Reduced Quantity of Percocet Percocet Only
Hide 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

Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: score on a scale
3.55  (1.68) 3.20  (1.98)
5.Primary Outcome
Title Score on Visual Analog Scale (VAS) of Pain
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Along With a Reduced Quantity of Percocet Percocet Only
Hide 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

Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: score on a scale
3.20  (1.79) 2.83  (2.11)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Acetaminophen Along With a Reduced Quantity of Percocet Percocet Only
Hide 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 (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%) 
Hide Serious Adverse Events
Acetaminophen Along With a Reduced Quantity of Percocet Percocet Only
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Acetaminophen Along With a Reduced Quantity of Percocet Percocet Only
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Thomas Youm, MD
Organization: NYU Langone Health
Phone: 212-348-3636
EMail: Thomas.Youm@nyulangone.org
Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03510910    
Other Study ID Numbers: 18-00167
First Submitted: April 18, 2018
First Posted: April 27, 2018
Results First Submitted: December 11, 2020
Results First Posted: January 7, 2021
Last Update Posted: January 7, 2021