Mepivacaine Versus Low-Dose Bupivacaine For Primary Total Hip and 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03838874|
Recruitment Status : Not yet recruiting
First Posted : February 12, 2019
Last Update Posted : February 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis Hip Osteoarthritis||Drug: Low-Dose Bupivacaine Drug: Mepivacaine||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||154 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Double Blind Randomized Clinical Trial Comparing Time To Return of Lower Extremity Motor Function Following Spinal Anesthetic With Mepivacaine Versus Low-Dose Bupivacaine For Primary Total Hip and Knee Arthroplasty|
|Estimated Study Start Date :||February 1, 2019|
|Estimated Primary Completion Date :||February 1, 2021|
|Estimated Study Completion Date :||July 1, 2021|
Active Comparator: Low-Dose Bupivacaine
Subjects in this group will be given 10mg of Low-Dose Bupivacaine, which is within standard of care for spinal anesthesia during TKA or THA. A standardized study card will be used to track patients throughout their various phases of care.
Drug: Low-Dose Bupivacaine
Active Comparator: Mepivacaine
Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA. A standardized study card will be used to track patients throughout their various phases of care.
- Time to return of lower extremity motor function [ Time Frame: End of Study (6-9 Days post operation) ]To evaluate the time to return of lower extremity motor function between mepivacaine and low-dose bupivacaine spinal anesthetic among patients undergoing primary total knee arthroplasty and total hip arthroplasty. This will be assessed by measuring time from spinal anesthetic administration to postoperative achievement of Bromage 0 function (return of spontaneous ankle, knee, and hip movement) in the non-operative extremity.
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): NCT03838874
|Contact: Jessica L Stutzmanemail@example.com|
|United States, Minnesota|
|Mayo Clinic in Rochester||Not yet recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Matthew P Abdel, M.D. 507-284-2884 firstname.lastname@example.org|
|Contact: Jessica Stutzman 507-255-3602 Stutzman.Jessica@mayo.edu|
|Principal Investigator: Matthew P Abdel, M.D.|
|Principal Investigator:||Matthew P Abdel, MD||Mayo Clinic|