Clinical Trial: Intra-Venous Acetaminophen and Muscle Relaxants After Total Knee

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Orph

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 Summary:

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 o
Sponsor: Florida Hospital

Current Primary Outcome:

• Routine Pain Intensity Scores [ Time Frame: 48 hours ]
  verbal subjective assessment by patient reported to nursing at standard assessment times as an ordinal number between 0 and 10 (inclusive) where 0 is no pain and 10 is the maximum pain imaginable
• Abbreviated Pain Intensity Scores [ Time Frame: 48 hours ]
  Verbal subjective assessment by patient reported to nursing at standard assessment times as either "mild", "moderate", or "severe".
• Opioid Consumption, [ Time Frame: 48 hours ]
  recorded by nursing with dose and time. Cumulative and total opioid consumption will be analyzed.
• Physical therapy metrics/goals [ Time Frame: 48 hours ]
  measured and recorded by physical therapist in daily chart notes quantifying ability to get out of bed, range of motion (in flexion/extension degrees) and average and maximum ambulation (in feet) during postoperative days 0 to 2.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• PACU discharge [ Time Frame: 48 hours ]
  Time to discharge from the PACU will be measured from PACU arrival to time of PACU discharge criteria met in minutes.
• Hospital Discharge [ Time Frame: 48 hours ]
  Time to discharge from the hospital will be measured from time/date of surgical incision to time/date that hospital discharge criteria is met, measured in hours.
• Patient satisfaction [ Time Frame: 48 hours ]
  19 point validated questionnaire of perioperative satisfaction with items for regional anesthesia
• Cost as measured by [ Time Frame: 48 hours ]
  study medication acquisition cost reported by pharmacy, study medication administration cost reported by pharmacy and nursing, length of stay cost reported by hospital accounting.

Original Secondary Outcome: Same as current

Information By: Florida Hospital

Dates:
Date Received: May 14, 2015
Date Started: April 2015
Date Completion: December 2016
Last Updated: February 3, 2016
Last Verified: February 2016