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