Trial | NCT02449369  Report issue

Title

Intra-Venous Acetaminophen and Muscle Relaxants After Total Knee
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.

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    180
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.
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 Started
Apr 30
2015
Primary Completion
Sep 30
2016
Study Completion
Sep 30
2016
Last Update
Aug 31
2017

Drug Preop acetaminophen IV

  • Other names: Ofirmev

Drug Preop orphenadrine IV

  • Other names: Norflex

Drug Postop oral oxycodone & acetaminophen

  • Other names: Percocet

Drug Postop hydromorphone IV

  • Other names: Dilaudid

Drug Postop oral orphenadrine

  • Other names: Norflex

Drug Postop oral oxycodone

  • Other names: Roxicodone

Drug Postop acetaminophen IV

  • Other names: Ofirmev

Drug Postop orphenadrine IV

  • Other names: Norflex

Control Active Comparator

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

Standard Active Comparator

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

IVAM Experimental

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

Criteria 

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
No Results Posted