At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 180 enrolled
Drug / intervention
Preop acetaminophen IV +7 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Intra-Venous Acetaminophen and Muscle Relaxants After Total Knee Arthroplasty (TKA). Prospective, Randomized, Open-label Trial to Determine if Switching From Oral to Intravenous Acetaminophen and Orphenadrine for 48 Hours After TKA Improves Outcomes.
In Brief
A Phase 4 clinical trial evaluating Preop acetaminophen IV, Preop orphenadrine IV, and 6 other interventions for Unilateral Knee Arthroplasty. Completed, enrolled 180 participants across 1 site.
Detailed Summary
This is a prospective, three-arm, randomized, open-label trial to determine if a new pain control protocol which includes regular dosing of intravenous acetaminophen and orphenadrine for 48 hours after total knee surgery reduces the need for opioid pain medication and reduces average pain scores.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUnilateral Knee Arthroplasty
CountriesUnited States
CollaboratorsSagent Pharmaceuticals Inc.
Timeline
Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartApr 2015
First PostedMay 2015
Primary CompletionSep 2016
TodayJul 2026
First PostedMay 20, 2015
Enrollment StartApr 1, 2015
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 11.1 years ago
Interventions
Preop acetaminophen IVdrug
Preop orphenadrine IVdrug
Postop oral oxycodone & acetaminophendrug
Postop hydromorphone IVdrug
Postop oral orphenadrinedrug
Postop oral oxycodonedrug
Postop acetaminophen IVdrug
Postop orphenadrine IVdrug