Phase 4
N=81
Intravenous Versus Oral Acetaminophen in Primary Total Hip Arthroplasty
Osteoarthritis · Acetaminophen · Arthroplasty, Hip Replacement
Bottom Line
View on ClinicalTrials.gov: NCT02839876 ↗Enrolled (actual)
81
Serious AEs
1.7%
Results posted
Jan 2020
Primary outcome: Primary: 24 Hour Opioid Consumption — 3.0; 3.4 morphine milliequivalent
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Intravenous acetaminophen (Drug); Oral acetaminophen (Drug)
- Age
- Adult, Older Adult · 56+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 24 Hour Opioid Consumption |
3.0; 3.4 | — |
| SECONDARY Opioid Consumption (Other) |
6.2; 6.8 | — |
| SECONDARY Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (Preoperatively) |
1.0; 2.0 | — |
| SECONDARY Pain Scores, as Measured by the 11-point Numeric Rating Scale (NRS-11) (1 Hour After Arrival to PACU) |
2.0; 2.0 | — |
| SECONDARY Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (8 Hours) |
3.0; 5.5 | — |
| SECONDARY Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (24 Hours) |
5.0; 4.0 | — |
| SECONDARY Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (36 Hours) |
5.0; 4.5 | — |
| SECONDARY Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (48 Hours) |
5.0; 5.0 | — |
| SECONDARY Subject Satisfaction at 24 Hours |
9; 9 | — |
| SECONDARY Subject Satisfaction at 48 Hours (48 Hours) |
9; 9 | — |
| SECONDARY Straight Leg Raise |
16; 11 | — |
| SECONDARY Heel Slide Test |
25; 16 | — |
| SECONDARY Number of Participants Able to Complete the Supine to Sit Test |
10; 6 | — |
| SECONDARY Self-paced Walk Test |
86; 63 | — |
| SECONDARY Number of Participants With Opioid-related Adverse Events |
15; 7 | — |
| SECONDARY Analgesic Consumption as Measured by Patient Diary |
0; 0 | — |
| SECONDARY Worst Pain (Day 30) |
1.0; 0 | — |
| SECONDARY Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (Preoperatively) |
1.0; 2.0 | — |
| SECONDARY Pain Scores, as Measured by the 11-point Numeric Rating Scale (NRS-11) (1 Hour After Arrival to PACU) |
2.0; 2.0 | — |
| SECONDARY Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (8 Hours) |
3.0; 5.5 | — |
| SECONDARY Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (24 Hours) |
5.0; 4.0 | — |
| SECONDARY Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (36 Hours) |
5.0; 4.5 | — |
| SECONDARY Subject Satisfaction at 48 Hours |
9; 9 | — |
| SECONDARY Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (48 Hours) |
5.0; 5.0 | — |
Summary
The purpose of this study is to determine if intravenous acetaminophen is superior to oral acetaminophen when used as part of a multimodal pathway for primary total hip arthroplasty.
Eligibility Criteria
Inclusion Criteria
- Patients scheduled for elective, primary total hip replacement for osteoarthritis
- American Society of Anesthesiologists (ASA) Physical Classification I-III
- Weight 50 kg or greater
- Body mass index 18-40 kg/m2
Exclusion Criteria
- Inability to consent to study
- Inability to speak English
- Pregnancy
- Weight <50 kg
- Revision hip replacement or emergency surgery
- Contraindications to spinal anesthesia: coagulopathy or bleeding diathesis, local infection, allergy to local anesthetics
- Allergies/intolerances/contraindications to any of the multimodal agents: acetaminophen, pregabalin, celecoxib, ketamine, or dexamethasone
- Chronic pain from a separate source other than operative hip
- Daily opioid equivalent use of 30 mg of morphine or greater at time of consent
- History of heart failure
- History of drug or alcohol abuse
- Rheumatoid arthritis
- Uncontrolled anxiety, schizophrenia or other psychiatric disorder that, in the opinion of the investigator, may interfere with the study assessments
- Chronic malnutrition, renal or liver impairment
- Hypersensitivity to acetaminophen or any of its excipients
Data sourced from ClinicalTrials.gov (NCT02839876). 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.