Overview

Intra-Venous Acetaminophen and Muscle Relaxants After Total Knee

Status:
Completed
Trial end date:
2016-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
AdventHealth
Florida Hospital
Collaborators:
Sagent Pharmaceuticals Inc.
Sagent Pharmaceuticals, Inc.
Treatments:
Acetaminophen
Hydromorphone
Orphenadrine
Oxycodone
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