Trial Outcomes & Findings for Multimodal Analgesia With Acetaminophen vs. Narcotics Alone After Hip Arthroscopy (NCT NCT03510910)

NCT ID: NCT03510910

Last Updated: 2021-01-07

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 100 participants
• Primary outcome timeframe: 7 days post-surgery
• Results posted on: 2021-01-07

Participant Flow

Participant milestones

Measure	Acetaminophen Along With a Reduced Quantity of Percocet 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 Only 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 Study STARTED	42	43
Overall Study COMPLETED	40	40
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	Acetaminophen Along With a Reduced Quantity of Percocet 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 Only 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 Study Incomplete Survey	2	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Acetaminophen Along With a Reduced Quantity of Percocet n=40 Participants 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 Only n=40 Participants 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 n=80 Participants Total of all reporting groups
Age, Continuous	39.43 years STANDARD_DEVIATION 13.1 • n=40 Participants	40.2 years STANDARD_DEVIATION 16.5 • n=40 Participants	39.82 years STANDARD_DEVIATION 14.8 • n=80 Participants
Sex: Female, Male Female	24 Participants n=40 Participants	22 Participants n=40 Participants	46 Participants n=80 Participants
Sex: Female, Male Male	16 Participants n=40 Participants	18 Participants n=40 Participants	34 Participants n=80 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	40 participants n=40 Participants	40 participants n=40 Participants	80 participants n=80 Participants

PRIMARY outcome

Timeframe: 7 days post-surgery

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

Outcome measures

Measure	Acetaminophen Along With a Reduced Quantity of Percocet n=40 Participants 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 Only n=40 Participants 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
Patient Satisfaction	8.48 score on a scale Standard Deviation 1.52	8.83 score on a scale Standard Deviation 1.55

PRIMARY outcome

Timeframe: 7 days post-surgery

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

Outcome measures

Measure	Acetaminophen Along With a Reduced Quantity of Percocet n=40 Participants 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 Only n=40 Participants 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
Morphine-equivalent Consumption	6.33 pills Standard Deviation 7.1	5.69 pills Standard Deviation 5.8

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Acetaminophen Along With a Reduced Quantity of Percocet n=40 Participants 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 Only n=40 Participants 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
Score on Visual Analog Scale (VAS) of Pain	5.30 score on a scale Standard Deviation 2.02	4.98 score on a scale Standard Deviation 2.24

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Acetaminophen Along With a Reduced Quantity of Percocet n=40 Participants 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 Only n=40 Participants 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
Score on Visual Analog Scale (VAS) of Pain	3.55 score on a scale Standard Deviation 1.68	3.20 score on a scale Standard Deviation 1.98

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Acetaminophen Along With a Reduced Quantity of Percocet n=40 Participants 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 Only n=40 Participants 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
Score on Visual Analog Scale (VAS) of Pain	3.20 score on a scale Standard Deviation 1.79	2.83 score on a scale Standard Deviation 2.11

Adverse Events

Acetaminophen Along With a Reduced Quantity of Percocet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Percocet Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Thomas Youm, MD

NYU Langone Health

Phone: 212-348-3636

Email: Thomas.Youm@nyulangone.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place