NCT02839876

Intravenous Versus Oral Acetaminophen in Primary Total Hip Arthroplasty

Comparison of Multimodal Analgesic Regimen With Intravenous Acetaminophen to Standard Oral Multimodal Therapy in Primary Total Hip Arthroplasty: A Randomized Controlled Double Blind Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 56 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single center, prospective, randomized controlled study. 60 subjects will be recruited (see #6 Recruitment and Compensation below). On the day of surgery, subjects will be randomized to receive either the study intervention (intravenous acetaminophen and placebo tablets) or the control intervention (intravenous saline and active acetaminophen tablets). The Investigational Drug Service will prepare each intervention package, which will include one intravenous and one oral medication dose. Only one of these routes will be active (determined by randomization). Subjects will receive doses of both an intravenous and oral study drug every 6 hours in order to maintain blinding, and will receive a total of 4 doses of each (at 0, 6, 12 and 18 hours). The dose of acetaminophen in all cases will be 1000 mg. The volume of intravenous acetaminophen (and saline) will be 100 mL. The oral dose will consist of two (2) tablets of 500 mg each (or two matching placebo tablets). All subjects will receive a standardized anesthetic regimen for total hip arthroplasty, as follows: A) Preoperative phase Subjects will receive the following preoperative multimodal drugs: * Pregabalin 75 mg PO * Celecoxib 200 mg PO * The interventional drugs, both IV and PO . The time that these drugs are administered will be recorded as time zero. Patients will then receive a spinal anesthetic with 12.5 mg of isobaric bupivacaine. No peripheral nerve blocks will be performed. B) Intraoperative phase All subjects will be receive propofol infusion beginning at 50 mg/kg/min and titrated to a Richmond Agitation-Sedation Scale score of -1 to -3 (drowsy to moderate sedation). Dexamethasone 10 mg IV and ketamine 0.25 mg/kg IV up to 40 mg total will be administered as part of the standard multimodal regimen. If required, subjects may receive fentanyl 25 mcg IV as needed to treat discomfort. No joint infiltration will be performed by the surgeon. C) Postoperative phase In the Post-Anesthesia Care Unit (PACU), subjects will have an intravenous patient-controlled analgesia (IVPCA) device connected and loading doses of hydromorphone administered by the PACU nurse as necessary (0.2 mg q 8 min prn). On the floor, subjects will receive: * Pregabalin 75 mg PO BID until discharge * Celecoxib 200 mg PO BID until discharge * Dexamethasone 10 mg IV x 1 on postoperative day 1 (24 hours after the first dose) * Intravenous patient-controlled analgesia (IVPCA) with hydromorphone (0.2 mg q 8 min). The remaining 3 intervention packages (IV and PO) will be administered at 6, 12 and 18 hours following the first dose. At time point 24 hours (i.e. the fifth dose of acetaminophen), all subjects will begin to receive 975 mg of oral acetaminophen, continuing every six hours until discharge.

Conditions

• Osteoarthritis
• Acetaminophen
• Arthroplasty, Hip Replacement

Interventions

Type	Name	Description
DRUG	Intravenous acetaminophen	Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.
DRUG	Oral acetaminophen	Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.

Timeline

• Start date: 2017-03-14
• Primary completion: 2018-10-02
• Completion: 2018-10-31
• First posted: 2016-07-21
• Last updated: 2021-03-09
• Results posted: 2020-01-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study