- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05765682
Mepivacaine vs. Bupivacaine Spinal for TKA
May 2, 2023 updated by: Clinton F. Pillow, Medical University of South Carolina
Mepivacaine vs. Bupivacaine Spinal: Effect on Return of Motor Function, Time to Ambulation, and Length of Stay in Total Knee Arthroplasty
This study will enroll patients 18-75 years of age who are undergoing elective primary total knee replacement.
The patients will be randomized to receive one of two spinal blocks: 1) mepivacaine or 2) bupivacaine.
The primary goal is to determine which group arrives at recovery of motor function first.
Ultimately, this study will explore if mepivacaine leads to earlier return of motor function and ultimately earlier movement and discharge times following total knee replacement.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
160
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Recruiting
- Medical University of South Carolina
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Ages 18-75 years of age
- Undergoing elective primary total knee arthroplasty
Exclusion Criteria:
- Inability to ambulate or impaired motor function in lower extremities prior to surgery
- Contraindication to spinal anesthetic
- Taking over 30mg oxycodone per day (or calculated MME equivalent)
- Subjects that are unable or choose not to give informed consent
- Known preoperative substance abuse
- Pregnant women
- Allergy to all opioids
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Mepivacaine Spinal
Mepivacaine (60 mg: 3ml of 2%) or will be injected into the intrathecal space.
|
spinal block using 60mg of mepivacaine
|
Active Comparator: Bupivacaine Spinal
Isobaric bupivacaine (10mg: 2ml or 0.5%) will be injected into the intrathecal space.
|
spinal block using 10mg of bupivacaine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time until return of motor function following spinal placement
Time Frame: From anesthesia stop time until 7 days post-op
|
This will be defined as full strength with both 1) foot plantar and dorsiflexion and 2) hip flexion in the operative extremity.
|
From anesthesia stop time until 7 days post-op
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ambulation
Time Frame: from anesthesia stop time until 7 days post-op
|
Time to first ambulation and distance at first ambulation
|
from anesthesia stop time until 7 days post-op
|
Length of Stay
Time Frame: Time from anesthesia end time to when discharge order is written, up to 30 days post-op
|
based on anesthesia end time to time discharge order written
|
Time from anesthesia end time to when discharge order is written, up to 30 days post-op
|
Side Effects
Time Frame: 0-48 hours post spinal placement
|
Side effects such as Urinary retention, dizziness, symptomatic hypotension, transient neurologic symptoms
|
0-48 hours post spinal placement
|
Pain Scores
Time Frame: Pacu to 48 hours post-spinal placement
|
Visual Analog Pain Score 0-100 pain scores at rest, and with movement.
A lower pain score means a better outcome.
|
Pacu to 48 hours post-spinal placement
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Preoperative opioid use
Time Frame: within past 90 days at time of procedure
|
Use of opioids in the pre-operative period converted to MME (morphine equivalent)
|
within past 90 days at time of procedure
|
Tourniquet use
Time Frame: during procedure for up to 7 days hours after procedure ends
|
Whether or not a tourniquet is used during surgery will be recorded as yes or no.
|
during procedure for up to 7 days hours after procedure ends
|
Cement use
Time Frame: during procedure or up to 7 days hours after procedure ends
|
Whether or not a cement is used during surgery will be recorded as yes or no.
|
during procedure or up to 7 days hours after procedure ends
|
Robotic or not
Time Frame: during procedure or up to 7 days hours after procedure ends
|
Whether or not the procedure is robotic or not will be recorded as yes or no.
|
during procedure or up to 7 days hours after procedure ends
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Clinton Pillow, MD, Medical University of South Carolina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 13, 2023
Primary Completion (Anticipated)
August 15, 2024
Study Completion (Anticipated)
August 15, 2025
Study Registration Dates
First Submitted
January 27, 2023
First Submitted That Met QC Criteria
March 9, 2023
First Posted (Actual)
March 13, 2023
Study Record Updates
Last Update Posted (Estimate)
May 4, 2023
Last Update Submitted That Met QC Criteria
May 2, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00125382
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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