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

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TiZANidine 2 MG Oral Capsule
Sponsored by
Rothman Institute Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rothman Orthopaedic Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Multimodal Pain Regimen

Multimodal Pain Regimen + Tizanidine

Arm Description

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.

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

Outcomes

Primary Outcome Measures

opioid consumption (MME) postoperatively
Primary outcome is patients total opioid consumption for the first 14 days after surgery.

Secondary Outcome Measures

Full Information

First Posted
September 29, 2020
Last Updated
September 29, 2020
Sponsor
Rothman Institute Orthopaedics
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1. Study Identification

Unique Protocol Identification Number
NCT04574791
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 3, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multimodal Pain Regimen
Arm Type
No Intervention
Arm Description
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.
Arm Title
Multimodal Pain Regimen + Tizanidine
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
TiZANidine 2 MG Oral Capsule
Intervention Description
Tizanidine 2 mg q8h (standing; # 42 tablets) + Multimodal pain regimen
Primary Outcome Measure Information:
Title
opioid consumption (MME) postoperatively
Description
Primary outcome is patients total opioid consumption for the first 14 days after surgery.
Time Frame
the first 14-days postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Rothman Orthopaedic Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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