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OpenTrials
Completed

NCT Number: NCT02449369

Intra-Venous Acetaminophen and Muscle Relaxants After Total Knee

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Florida Hospital Winter Park

Winter Park, Florida, 32792, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-85
  • Primary, unilateral total knee arthroplasty
  • American Society of Anesthesiologist (ASA) physical status I, II, or III

Exclusion criteria

  • Chronic pain (as determined by regular opioid use in the month preceding surgery)
  • Preoperative use of centrally acting muscle relaxants in the 24 hours preceding surgery
  • Peripheral regional anesthesia procedures other than femoral nerve injections or catheters for postoperative pain control (such as popliteal block)
  • Severe renal dysfunction, creatinine > 2.0
  • Allergy or other contraindications to use of orphenadrine and/or acetaminophen
  • Pregnant or breast feeding
  • Abnormal Liver Function Tests(LFT) and / or history of chronic/excessive alcohol abuse.
  • History of Hepatitis, B or C,
  • History of cirrhosis or hepatic insufficiency

Treatment and study plan

Preop acetaminophen IV

Drug

Other names: Ofirmev

Preop orphenadrine IV

Drug

Other names: Norflex

Postop oral oxycodone & acetaminophen

Drug

Other names: Percocet

Postop hydromorphone IV

Drug

Other names: Dilaudid

Postop oral orphenadrine

Drug

Other names: Norflex

Postop oral oxycodone

Drug

Other names: Roxicodone

Postop acetaminophen IV

Drug

Other names: Ofirmev

Postop orphenadrine IV

Drug

Other names: Norflex

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AdventHealth

Other

Collaborators

  • Sagent Pharmaceuticals Inc.

Registry information

Official study 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.

Acronym: IVAM

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 20, 2015
Registry last updated
Aug 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.