Intra-Venous Acetaminophen and Muscle Relaxants After Total Knee (IVAM)

August 29, 2017 updated by: AdventHealth

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Winter Park, Florida, United States, 32792
        • Florida Hospital Winter Park

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Preop acetaminophen IV 1000 mg, Postop oral oxycodone & acetaminophen (5/325 mg) 1 to 2 tabs every 4 hours PRN, and Postop hydromorphone IV 0.5 mg every 4 hours PRN
Drug: Preop acetaminophen IV
Other Names:
  • Ofirmev
Drug: Postop oral oxycodone & acetaminophen
Other Names:
  • Percocet
Drug: Postop hydromorphone IV
Other Names:
  • Dilaudid
Active Comparator: Standard
Preop acetaminophen IV 1000 mg, Preop orphenadrine IV 60 mg, Postop oral orphenadrine 100 mg every 12 hours for 3 doses, Postop oral oxycodone & acetaminophen (5/325 mg) 1 to 2 tabs every 4 hours PRN, Postop hydromorphone IV 0.5 mg every 4 hours PRN
Drug: Preop acetaminophen IV
Other Names:
  • Ofirmev
Drug: Postop oral oxycodone & acetaminophen
Other Names:
  • Percocet
Drug: Postop hydromorphone IV
Other Names:
  • Dilaudid
Drug: Preop orphenadrine IV
Other Names:
  • Norflex
Drug: Postop oral orphenadrine
Other Names:
  • Norflex
Experimental: IVAM
Preop acetaminophen IV 1000 mg, Preop orphenadrine IV 60 mg, Postop acetaminophen IV 1000 mg every 6 hours for 7 doses, Postop orphenadrine IV 60 mg every 12 hours for 3 doses, Postop oral oxycodone 5 mg 1 to 2 tabs every 4 hours PRN, Postop hydromorphone IV 0.5 mg every 4 hours PRN
Drug: Preop acetaminophen IV
Other Names:
  • Ofirmev
Drug: Postop hydromorphone IV
Other Names:
  • Dilaudid
Drug: Preop orphenadrine IV
Other Names:
  • Norflex
Drug: Postop oral oxycodone
Other Names:
  • Roxicodone
Drug: Postop acetaminophen IV
Other Names:
  • Ofirmev
Drug: Postop orphenadrine IV
Other Names:
  • Norflex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
48 hours
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".
48 hours
Opioid Consumption,
Time Frame: 48 hours
recorded by nursing with dose and time. Cumulative and total opioid consumption will be analyzed.
48 hours
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.
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 hours
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.
48 hours
Patient satisfaction
Time Frame: 48 hours
19 point validated questionnaire of perioperative satisfaction with items for regional anesthesia
48 hours
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.
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth

Collaborators

Sagent Pharmaceuticals Inc.

Investigators

  • Principal Investigator: thomas Looke, MD, AdventHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

May 14, 2015

First Submitted That Met QC Criteria

May 16, 2015

First Posted (Estimate)

May 20, 2015

Study Record Updates

Last Update Posted (Actual)

August 31, 2017

Last Update Submitted That Met QC Criteria

August 29, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 521770

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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