Intravenous Versus Oral Acetaminophen in Primary Total Hip Arthroplasty

NCT02839876 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: Pro00072610
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis; Acetaminophen; Arthroplasty, Hip Replacement

Outcome Measures

Primary Outcomes (1)

• 24 Hour Opioid Consumption

  Cumulative dose of hydromorphone consumed in the first 24 hours postoperatively

  24 hours

Secondary Outcomes (23)

• Opioid Consumption (Other)

  0-48 hours

• Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (Preoperatively)

  preoperatively

• Pain Scores, as Measured by the 11-point Numeric Rating Scale (NRS-11) (1 Hour After Arrival to PACU)

  1 hour after arrival to PACU

• Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (8 Hours)

  8 hours

• Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (24 Hours)

  24 hours

Other Outcomes (5)

• Hospital Length of Stay

  0-72 hours

• Overall Hospital Admission Costs

  0-72 hours

• Pharmacy-related Costs

  0-72 hours

Study Arms (2)

Intravenous acetaminophen

EXPERIMENTAL

Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.

Drug: Intravenous acetaminophen

Oral acetaminophen

ACTIVE COMPARATOR

Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.

Drug: Oral acetaminophen

Interventions

Intravenous acetaminophen DRUG

Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.

Also known as: Ofirmev

Intravenous acetaminophen

Oral acetaminophen DRUG

Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.

Oral acetaminophen

Eligibility Criteria

• Age: 56 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Jeff Gadsden
• Organization: Duke University Medical Center

jeff.gadsden@duke.edu

919-681-6437

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: July 21, 2016
• Study Start: March 14, 2017
• Primary Completion: October 2, 2018
• Study Completion: October 31, 2018
• Last Updated: March 9, 2021
• Results First Posted: January 18, 2020

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)