Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty
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| ClinicalTrials.gov Identifier: NCT04574791 |
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Recruitment Status :
Enrolling by invitation
First Posted : October 5, 2020
Last Update Posted : October 5, 2020
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Sponsor:
Rothman Institute Orthopaedics
Information provided by (Responsible Party):
Rothman Institute Orthopaedics
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pain, Postoperative | Drug: TiZANidine 2 MG Oral Capsule | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 240 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty |
| Actual Study Start Date : | September 3, 2020 |
| Estimated Primary Completion Date : | September 30, 2021 |
| Estimated Study Completion Date : | September 30, 2021 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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.
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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
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Drug: TiZANidine 2 MG Oral Capsule
Tizanidine 2 mg q8h (standing; # 42 tablets) + Multimodal pain regimen |
Primary Outcome Measures :
- 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.
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04574791
Locations
| United States, Pennsylvania | |
| Rothman Orthopaedic Institute | |
| Philadelphia, Pennsylvania, United States, 19107 | |
Sponsors and Collaborators
Rothman Institute Orthopaedics
| Responsible Party: | Rothman Institute Orthopaedics |
| ClinicalTrials.gov Identifier: | NCT04574791 |
| Other Study ID Numbers: |
MAUS20d635 |
| First Posted: | October 5, 2020 Key Record Dates |
| Last Update Posted: | October 5, 2020 |
| Last Verified: | September 2020 |
| 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 |
Additional relevant MeSH terms:
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Muscle Hypotonia Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Neuromuscular Manifestations Nervous System Diseases Tizanidine Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Anticonvulsants Muscle Relaxants, Central Neuromuscular Agents Parasympatholytics Autonomic Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |