Clinical trial NCT02449369: Intra-Venous Acetaminophen and Muscle Relaxants After Total Knee
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Unilateral Knee Arthroplasty
Lead sponsor: AdventHealth
Sponsor class: OTHER
Collaborators: name: Sagent Pharmaceuticals Inc.
First posted: 2015-05-20
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This research will be a prospective, three-arm, randomized, open-label trial to assess opioid use and patient reported outcomes after 48 hours of regular IV acetaminophen and muscle relaxant (IVAM) orphenadrine administration following total knee replacement surgery. 180 patients (60 in each arm) will be randomized to receive the standard group treatment, the IVAM group treatment, or to the control grouptreatment.

Standard Group Treatment: includes peripheral nerve single injection or catheter infusions (48 hours) as requested by the surgeon; preoperative (single dose) intravenous acetaminophen (1000 mg) and orphenadrine (60 mg); intraoperative spinal anesthesia or general anesthesia as determined by the anesthesia attending physician; postoperative oral oxycodone (5 mg) with acetaminophen (325 mg) (PRN dosing), oral orphenadrine (100 mg) every 12 hours for 3 doses, and intravenous hydromorphone (PRN dosing) for breakthrough pain.

Control Group Treatment: includes peripheral nerve single injection or catheter infusions (48 hours); preoperative (single dose) intravenous acetaminophen (1000 mg) intraoperative spinal anesthesia or general anesthesia as determined by the anesthesia attending physician; and postoperative oral oxycodone and acetaminophen (PRN dosing), and intravenous hydromorphone (PRN dosing) for breakthrough pain.

IVAM Group Treatment: includes peripheral nerve single injection or catheter infusions (48 hours); preoperative intravenous acetaminophen (1000 mg) and orphenadrine (60 mg); intraoperative spinal anesthesia or general anesthesia as determined by the anesthesia attending physician; postoperative intravenous acetaminophen (1000 mg) every 6 hours routine for total of 8 doses and intravenous orphenadrine (60 mg) every 12 hours for total of 4 doses; oral oxycodone (5 mg) (PRN dosing), and intravenous hydromorphone (PRN dosing) for breakthrough pain.

Eligibility criteria: Inclusion Criteria:

1. Age 18-85
2. Primary, unilateral total knee arthroplasty
3. American Society of Anesthesiologist (ASA) physical status I, II, or III

Exclusion Criteria:

1. Chronic pain (as determined by regular opioid use in the month preceding surgery)
2. Preoperative use of centrally acting muscle relaxants in the 24 hours preceding surgery
3. Peripheral regional anesthesia procedures other than femoral nerve injections or catheters for postoperative pain control (such as popliteal block)
4. Severe renal dysfunction, creatinine \> 2.0
5. Allergy or other contraindications to use of orphenadrine and/or acetaminophen
6. Pregnant or breast feeding
7. Abnormal Liver Function Tests(LFT) and / or history of chronic/excessive alcohol abuse.
8. History of Hepatitis, B or C,
9. History of cirrhosis or hepatic insufficiency

Primary outcomes:
measure: Routine Pain Intensity Scores
timeFrame: 48 hours
measure: Abbreviated Pain Intensity Scores
timeFrame: 48 hours
measure: Opioid Consumption,
timeFrame: 48 hours
measure: Physical therapy metrics/goals
timeFrame: 48 hours
Secondary outcomes:
measure: PACU discharge
timeFrame: 48 hours
measure: Hospital Discharge
timeFrame: 48 hours
measure: Patient satisfaction
timeFrame: 48 hours
measure: Cost as measured by
timeFrame: 48 hours
Other outcomes:
Locations:
city: Winter Park
country: United States
facility: Florida Hospital Winter Park
state: Florida
Study officials:
affiliation: AdventHealth
name: thomas Looke, MD
role: PRINCIPAL_INVESTIGATOR
References:
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