Phase 4
N=85
Multimodal Analgesia With Acetaminophen vs. Narcotics Alone After Hip Arthroscopy
Hip Arthroscopy
Bottom Line
View on ClinicalTrials.gov: NCT03510910 ↗Enrolled (actual)
85
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Patient Satisfaction — 8.48; 8.83 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Acetaminophen (Drug); Percocet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Satisfaction |
8.48; 8.83 | — |
| PRIMARY Morphine-equivalent Consumption |
6.33; 5.69 | — |
| PRIMARY Score on Visual Analog Scale (VAS) of Pain |
3.20; 2.83 | — |
| PRIMARY Score on Visual Analog Scale (VAS) of Pain |
3.20; 2.83 | — |
| PRIMARY Score on Visual Analog Scale (VAS) of Pain |
3.20; 2.83 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03510910). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.