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

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ClinicalTrials.gov Identifier: NCT02449369
Recruitment Status : Completed
First Posted : May 20, 2015
Last Update Posted : August 31, 2017
Sponsor:
Collaborator:
Sagent Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Florida Hospital

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.

Condition or disease Intervention/treatment Phase
Unilateral Knee Arthroplasty Drug: 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 Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


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 Name: Ofirmev

Drug: Postop oral oxycodone & acetaminophen
Other Name: Percocet

Drug: Postop hydromorphone IV
Other Name: 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 Name: Ofirmev

Drug: Preop orphenadrine IV
Other Name: Norflex

Drug: Postop oral oxycodone & acetaminophen
Other Name: Percocet

Drug: Postop hydromorphone IV
Other Name: Dilaudid

Drug: Postop oral orphenadrine
Other Name: 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 Name: Ofirmev

Drug: Preop orphenadrine IV
Other Name: Norflex

Drug: Postop hydromorphone IV
Other Name: Dilaudid

Drug: Postop oral oxycodone
Other Name: Roxicodone

Drug: Postop acetaminophen IV
Other Name: Ofirmev

Drug: Postop orphenadrine IV
Other Name: Norflex




Primary Outcome Measures :
  1. 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

  2. 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".

  3. Opioid Consumption, [ Time Frame: 48 hours ]
    recorded by nursing with dose and time. Cumulative and total opioid consumption will be analyzed.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Patient satisfaction [ Time Frame: 48 hours ]
    19 point validated questionnaire of perioperative satisfaction with items for regional anesthesia

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02449369


Locations
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United States, Florida
Florida Hospital Winter Park
Winter Park, Florida, United States, 32792
Sponsors and Collaborators
Florida Hospital
Sagent Pharmaceuticals, Inc.
Investigators
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Principal Investigator: thomas Looke, MD Florida Hospital

Publications of Results:

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Responsible Party: Florida Hospital
ClinicalTrials.gov Identifier: NCT02449369     History of Changes
Other Study ID Numbers: 521770
First Posted: May 20, 2015    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Muscle Hypotonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Acetaminophen
Oxycodone
Hydromorphone
Orphenadrine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Antiparkinson Agents
Anti-Dyskinesia Agents
Muscle Relaxants, Central
Neuromuscular Agents
Parasympatholytics
Autonomic Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inhibitors