Total Knee Replacement
Conditions
Brief summary
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.
Interventions
OTHERMepivacaine Spinal
spinal block using 60mg of mepivacaine
OTHERBupivacaine Spinal
spinal block using 10mg of bupivacaine
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Masking description
Subject, surgeon, and care team members will be blinded to the assigned randomization group. The anesthesiologist will not be blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time until return of motor function following spinal placement | 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 and 3) knee flexion in the non-operative extremity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ambulation | from anesthesia stop time until 7 days post-op | Time to first ambulation and distance at first ambulation |
| Length of Stay | 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 |
| Side Effects | 0-48 hours post spinal placement | Side effects such as Urinary retention, dizziness, symptomatic hypotension, transient neurologic symptoms |
| Pain Scores | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Tourniquet use | 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. |
| Cement use | 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. |
| Robotic or not | 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. |
| Preoperative opioid use | within past 90 days at time of procedure | Use of opioids in the pre-operative period converted to MME (morphine equivalent) |
Countries
United States
Outcome results
None listed