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History of Changes for Study: NCT04574791
Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty
Latest version (submitted September 29, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 29, 2020 None (earliest Version on record)
Comparison Format:

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Study NCT04574791
Submitted Date:  September 29, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: MAUS20d635
Brief Title: Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty
Official Title: Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2020
Overall Status: Unknown status [Previously: Enrolling by invitation]
Study Start: September 3, 2020
Primary Completion: September 30, 2021 [Anticipated]
Study Completion: September 30, 2021 [Anticipated]
First Submitted: September 29, 2020
First Submitted that
Met QC Criteria:
September 29, 2020
First Posted: October 5, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
September 29, 2020
Last Update Posted: October 5, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Rothman Institute Orthopaedics
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Pain, Postoperative
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 240 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Drug: TiZANidine 2 MG Oral Capsule
Tizanidine 2 mg q8h (standing; # 42 tablets) + Multimodal pain regimen
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

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
Open or close this module Contacts/Locations
Locations: United States, Pennsylvania
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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