Intra-Venous Acetaminophen and Muscle Relaxants After Total Knee

NCT02449369 | Completed Phase 4

• 1 other identifier: 521770
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Unilateral Knee Arthroplasty

Outcome Measures

Primary Outcomes (4)

• Routine Pain Intensity Scores

  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

  Verbal subjective assessment by patient reported to nursing at standard assessment times as either "mild", "moderate", or "severe".

  48 hours

• Opioid Consumption,

  recorded by nursing with dose and time. Cumulative and total opioid consumption will be analyzed.

  48 hours

• Physical therapy metrics/goals

  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 Outcomes (4)

• PACU discharge

  48 hours

• Hospital Discharge

  48 hours

• Patient satisfaction

  48 hours

• Cost as measured by

  48 hours

Study Arms (3)

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

Drug: Preop acetaminophen IV; Drug: Postop oral oxycodone & acetaminophen; Drug: Postop hydromorphone IV

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

Drug: Preop acetaminophen IV; Drug: Preop orphenadrine IV; Drug: Postop oral oxycodone & acetaminophen; Drug: Postop hydromorphone IV; Drug: Postop oral orphenadrine

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

Drug: Preop acetaminophen IV; Drug: Preop orphenadrine IV; Drug: Postop hydromorphone IV; Drug: Postop oral oxycodone; Drug: Postop acetaminophen IV; Drug: Postop orphenadrine IV

Interventions

Preop acetaminophen IV DRUG

Also known as: Ofirmev

Control; IVAM; Standard

Preop orphenadrine IV DRUG

Also known as: Norflex

IVAM; Standard

Postop oral oxycodone & acetaminophen DRUG

Also known as: Percocet

Control; Standard

Postop hydromorphone IV DRUG

Also known as: Dilaudid

Control; IVAM; Standard

Postop oral orphenadrine DRUG

Also known as: Norflex

Standard

Postop oral oxycodone DRUG

Also known as: Roxicodone

IVAM

Postop acetaminophen IV DRUG

Also known as: Ofirmev

IVAM

Postop orphenadrine IV DRUG

Also known as: Norflex

IVAM

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• AdventHealth: lead
• Sagent Pharmaceuticals Inc.: collaborator

Study Sites (1)

Florida Hospital Winter Park

Winter Park, Florida, 32792, United States

Location

Related Publications (11)

• Looke TD, Kluth CT. Effect of preoperative intravenous methocarbamol and intravenous acetaminophen on opioid use after primary total hip and knee replacement. Orthopedics. 2013 Feb;36(2 Suppl):25-32. doi: 10.3928/01477447-20130122-54.

  PMID: 23379573 RESULT

• Hidalgo DA, Pusic AL. The role of methocarbamol and intercostal nerve blocks for pain management in breast augmentation. Aesthet Surg J. 2005 Nov-Dec;25(6):571-5. doi: 10.1016/j.asj.2005.09.003.

  PMID: 19338859 RESULT

• Schneider MS. Methocarbamol: adjunct therapy for pain management in breast augmentation. Aesthet Surg J. 2002 Jul;22(4):380-1. doi: 10.1067/maj.2002.126750.

  PMID: 19331993 RESULT

• Schneider MS. Pain reduction in breast augmentation using methocarbamol. Aesthetic Plast Surg. 1997 Jan-Feb;21(1):23-4. doi: 10.1007/s002669900076.

  PMID: 9204163 RESULT

• Gombotz H, Lochner R, Sigl R, Blasl J, Herzer G, Trimmel H. Opiate sparing effect of fixed combination of diclophenac and orphenadrine after unilateral total hip arthroplasty: A double-blind, randomized, placebo-controlled, multi-centre clinical trial. Wien Med Wochenschr. 2010 Nov;160(19-20):526-34. doi: 10.1007/s10354-010-0829-7. Epub 2010 Oct 8.

  PMID: 20890791 RESULT

• Malek J, Nedelova I, Lopourova M, Stefan M, Kostal R. [Diclofenac 75mg. and 30 mg. orfenadine (Neodolpasse) versus placebo and piroxicam in postoperative analgesia after arthroscopy]. Acta Chir Orthop Traumatol Cech. 2004;71(2):80-3. Czech.

  PMID: 15151094 RESULT

• Sinatra RS, Jahr JS, Reynolds L, Groudine SB, Royal MA, Breitmeyer JB, Viscusi ER. Intravenous acetaminophen for pain after major orthopedic surgery: an expanded analysis. Pain Pract. 2012 Jun;12(5):357-65. doi: 10.1111/j.1533-2500.2011.00514.x. Epub 2011 Oct 19.

  PMID: 22008309 RESULT

• Sinatra RS, Jahr JS, Reynolds LW, Viscusi ER, Groudine SB, Payen-Champenois C. Efficacy and safety of single and repeated administration of 1 gram intravenous acetaminophen injection (paracetamol) for pain management after major orthopedic surgery. Anesthesiology. 2005 Apr;102(4):822-31. doi: 10.1097/00000542-200504000-00019.

  PMID: 15791113 RESULT

• Korkmaz Dilmen O, Tunali Y, Cakmakkaya OS, Yentur E, Tutuncu AC, Tureci E, Bahar M. Efficacy of intravenous paracetamol, metamizol and lornoxicam on postoperative pain and morphine consumption after lumbar disc surgery. Eur J Anaesthesiol. 2010 May;27(5):428-32. doi: 10.1097/EJA.0b013e32833731a4.

  PMID: 20173643 RESULT

• Singla NK, Parulan C, Samson R, Hutchinson J, Bushnell R, Beja EG, Ang R, Royal MA. Plasma and cerebrospinal fluid pharmacokinetic parameters after single-dose administration of intravenous, oral, or rectal acetaminophen. Pain Pract. 2012 Sep;12(7):523-32. doi: 10.1111/j.1533-2500.2012.00556.x. Epub 2012 Apr 24.

  PMID: 22524979 RESULT

• Maurice-Szamburski A, Bruder N, Loundou A, Capdevila X, Auquier P. Development and validation of a perioperative satisfaction questionnaire in regional anesthesia. Anesthesiology. 2013 Jan;118(1):78-87. doi: 10.1097/ALN.0b013e31827469f2.

  PMID: 23221859 RESULT

MeSH Terms

Interventions

Acetaminophen; Orphenadrine; oxycodone-acetaminophen; Hydromorphone; Oxycodone

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethylamines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Codeine

Study Officials

• thomas Looke, MD

  AdventHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2015
• First Posted: May 20, 2015
• Study Start: April 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: August 31, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)