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Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04574791
Recruitment Status : Unknown
Verified September 2020 by Rothman Institute Orthopaedics.
Recruitment status was:  Enrolling by invitation
First Posted : October 5, 2020
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Tracking Information
First Submitted Date  ICMJE September 29, 2020
First Posted Date  ICMJE October 5, 2020
Last Update Posted Date October 5, 2020
Actual Study Start Date  ICMJE September 3, 2020
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2020)
opioid consumption (MME) postoperatively [ Time Frame: the first 14-days postoperatively ]
Primary outcome is patients total opioid consumption for the first 14 days after surgery.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty
Official Title  ICMJE Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty
Brief Summary This is a prospective, cluster-randomized, two-arm, comparative study aimed at determining whether addition of tizanidine ( an oral muscle relaxant) to a multimodal pain regimen following primary TKA reduces opioid consumption.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pain, Postoperative
Intervention  ICMJE Drug: TiZANidine 2 MG Oral Capsule
Tizanidine 2 mg q8h (standing; # 42 tablets) + Multimodal pain regimen
Study Arms  ICMJE
  • No Intervention: Multimodal Pain Regimen
    current standard of care post-operative pain regimen in the hospital, which comprises of standing doses of oral acetaminophen 975 mg three times a day, gabapentin 300 mg two times a day, and intravenous ketorolac 30 mg three times a day for patients <65 years and 15 mg IV Q8h for patients who are >65 years, supplemented with PRN oxycodone and tramadol.
  • Experimental: Multimodal Pain Regimen + Tizanidine
    current standard of care post-operative pain regimen in the hospital, which comprises of standing doses of oral acetaminophen 975 mg three times a day, gabapentin 300 mg two times a day, and intravenous ketorolac 30 mg three times a day for patients <65 years and 15 mg IV Q8h for patients who are >65 years, supplemented with PRN oxycodone and tramadol supplemented with standing doses of oral tizanidine in the hospital and for 14 days after discharge
    Intervention: Drug: TiZANidine 2 MG Oral Capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: September 29, 2020)
240
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2021
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • - Patients undergoing unilateral primary TKA with underlying diagnosis of osteoarthritis.
  • ASA I - III
  • Spinal anesthesia
  • All patients will have a total knee arthroplasty utilizing a medial parapatellar approach with cruciate sacrificing implants and patellar resurfacing. A tourniquet will be used in all cases.
  • Men and women between 18 and 80 years who are willing and able to provide informed consent

Exclusion Criteria:

  • Opioid use greater than 10 mg/day morphine equivalents continuously for one month within 3 months preoperatively
  • Inability to take/allergy to the protocol medications
  • Contraindication to regional anesthesia
  • Non-English speaking
  • ASA IV or greater
  • Psychiatric or cognitive disorders
  • Allergy/contraindications to protocol medications.
  • Renal insufficiency with Cr > 2.0 or hepatic failure
  • Sensory/motor disorder involving the operative limb
  • PCS score >20
  • Patients with severe cardiac or neurological conditions precluding the use of study medications
  • Patients using anticoagulation other than aspirin for the 14-day period after discharge
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04574791
Other Study ID Numbers  ICMJE MAUS20d635
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Rothman Institute Orthopaedics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Rothman Institute Orthopaedics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rothman Institute Orthopaedics
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP