Intra-Venous Acetaminophen and Muscle Relaxants After Total Knee

Condition(s) targeted: Unilateral Knee Arthroplasty

Intervention: Preop acetaminophen IV (Drug); Preop orphenadrine IV (Drug); Postop oral oxycodone & acetaminophen (Drug); Postop hydromorphone IV (Drug); Postop oral orphenadrine (Drug); Postop oral oxycodone (Drug); Postop acetaminophen IV (Drug); Postop orphenadrine IV (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Florida Hospital

Official(s) and/or principal investigator(s):
thomas Looke, MD, Principal Investigator, Affiliation: Florida Hospital

Overall contact:
Nadine McDaniel, BSN, Phone: 407 646 7970, Email: nadine.mcdaniel@flhosp.org

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.

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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Routine Pain Intensity Scores

Abbreviated Pain Intensity Scores

Opioid Consumption,

Physical therapy metrics/goals

Secondary outcome:

PACU discharge

Hospital Discharge

Patient satisfaction

Cost as measured by

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.

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

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

Nadine McDaniel, BSN, Phone: 407 646 7970, Email: nadine.mcdaniel@flhosp.org

Florida Hospital Winter Park, Winter Park, Florida 32792, United States; Recruiting
Nadine McDaniel, RN, Phone: 407-646-7970, Email: nadine.mcdaniel@flhosp.org
Thomas Looke, MD, Principal Investigator

Starting date: April 2015
Last updated: May 16, 2015