Hip Osteoarthritis, Knee Osteoarthritis
Conditions
Brief summary
This research is being done to see if there is a difference between two different spinal anesthetics (Mepivacaine vs. Bupivacaine) as it relates to reducing post-operative complications and the time it takes for subjects to regain mobility after surgery.
Interventions
DRUGLow-Dose Bupivacaine
10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic
DRUGMepivacaine
70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Days to No maximum
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists (ASA) physiological status I-III (patient must meet criteria of a status I-III in the ASA Physical Status Classification System: I=Normal Healthy Patient, II=Mild Systemic Disease, and III=Severe Systemic Disease) * Unilateral primary TKA or THA * 18+ years of age * Able to provide informed consent
Exclusion criteria
* Chronic pain syndromes such as fibromyalgia or complex regional pain syndrome * Chronic opioid use (\>1 mos) with OME \>5 mg/day OR acute opioid use (\< 1 mos) with OME \> 30 mg/day. * Body mass index (BMI) \> 45 kg/m2 * Severe drug allergy\* to medications used in this study, including non-steroidal anti-inflammatory drugs (i.e. celecoxib and ketorolac), and local anesthetics (defined as an immune reaction resulting in shortness of breath, hives, anaphylaxis, wheezing, and fever) * Major systemic medical comorbidities such as: * Pre-existing severe renal disorder defined as glomerular filtration rate (GFR) \<50 units/m2 (if labs are available), currently on dialysis, or highly suspected based on history. * Severe hepatic disorder defined as current or past diagnosis of acute/subacute necrosis of liver, acute hepatic failure, chronic liver disease, cirrhosis (primary biliary cirrhosis), chronic hepatitis/toxic hepatitis, liver abscess, hepatic coma, hepatorenal syndrome, other disorders of liver * Contraindication to spinal anesthesia technique (e.g., known spinal stenosis, coagulopathy, sepsis, infection at site of injection, uncooperative, refusal, anticoagulation medications not held within appropriate time frame\*). \*Per ASRA guidelines, Clopidogrel (Plavix) held for at least 7 days, Dabigatran (Pradexa) held for at least 5 days, Rivaroxaban (Xarelto)held for at least 3 days, Warfarin (Coumadin)held for at least 5 days or recent INR of less than 1.4, Enoxaparin (Lovenox) with doses \> 1 mg/kg held for close to 24 hours. * Known to be currently pregnant or actively breastfeeding. Patients that have a previous history of menopause, hysterectomy, or tubal ligation will not be required to perform a pregnancy test. Female patients that do not meet this criterion will be asked to submit a urine sample, and will require a negative urine sample in order to proceed with study protocol. Urine sample be collected pre-procedurally. * Impaired cognition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Return of Lower Extremity Motor Function | Post surgery, approximately 1 day | 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 at 15-minute intervals. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Length of Stay | Time of discharge, approximately 1-2 days | Number days subjects were admitted to the hospital following the surgical procedure |
| Maximum Pain Score | 24 hours following the surgical procedure | Measured on a scale from 1 to 10 in the first 24 hours following the surgical procedure, 1=mild pain; 10=worst pain. |
| Median Pain Score | 24 hours following the surgical procedure | Measured on a scale from 1 to 10 in the first 24 hours following the surgical procedure, 1=mild pain; 10=worst pain. |
| Post-Anesthesia Care Unit (PACU) Length of Stay | Time of discharge, approximately 1-2 days | Number of minutes subjects were admitted to PACU following the surgical procedure |
| Orthostatic Hypotension | Time of discharge, approximately 1-2 days | Number of participants to experience orthostatic hypotension following the surgical procedure. |
| Urinary Retention | Time of discharge, approximately 1-2 days | Number of participants to experience urinary retention follow the surgical procedure. |
| Transient Neurologic Symptoms | One week post-operative | Number of participants to report transient neurologic symptoms |
| Discharge Pain Score | Time of discharge, approximately 1-2 days | Measured on a scale from 1 to 10 at time of hospital discharge, 1=mild pain; 10=worst pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Low-Dose Bupivacaine: 10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic | 80 |
| Mepivacaine Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA.
Mepivacaine: 70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic | 74 |
| Total | 154 |
Baseline characteristics
| Characteristic | Mepivacaine | Total | Low-Dose Bupivacaine |
|---|---|---|---|
| Age, Continuous | 67.9 years STANDARD_DEVIATION 9.2 | 67.9 years STANDARD_DEVIATION 10 | 67.9 years STANDARD_DEVIATION 11.8 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 74 participants | 154 participants | 80 participants |
| Sex: Female, Male Female | 42 Participants | 88 Participants | 46 Participants |
| Sex: Female, Male Male | 32 Participants | 66 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 0 / 74 |
| other Total, other adverse events | 0 / 80 | 0 / 74 |
| serious Total, serious adverse events | 0 / 80 | 0 / 74 |
Outcome results
Primary
Time to Return of Lower Extremity Motor Function
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 at 15-minute intervals.
Time frame: Post surgery, approximately 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low-Dose Bupivacaine | Time to Return of Lower Extremity Motor Function | 210.3 minutes | Standard Deviation 79.54 |
| Mepivacaine | Time to Return of Lower Extremity Motor Function | 184.7 minutes | Standard Deviation 47.8 |
Secondary
Discharge Pain Score
Measured on a scale from 1 to 10 at time of hospital discharge, 1=mild pain; 10=worst pain.
Time frame: Time of discharge, approximately 1-2 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low-Dose Bupivacaine | Discharge Pain Score | 3.5 score on a scale | Standard Deviation 2.1 |
| Mepivacaine | Discharge Pain Score | 3.5 score on a scale | Standard Deviation 2.1 |
Secondary
Hospital Length of Stay
Number days subjects were admitted to the hospital following the surgical procedure
Time frame: Time of discharge, approximately 1-2 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low-Dose Bupivacaine | Hospital Length of Stay | 1.5 days | Standard Deviation 0.9 |
| Mepivacaine | Hospital Length of Stay | 1.4 days | Standard Deviation 0.8 |
Secondary
Maximum Pain Score
Measured on a scale from 1 to 10 in the first 24 hours following the surgical procedure, 1=mild pain; 10=worst pain.
Time frame: 24 hours following the surgical procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low-Dose Bupivacaine | Maximum Pain Score | 6.0 score on a scale | Standard Deviation 2.5 |
| Mepivacaine | Maximum Pain Score | 6.5 score on a scale | Standard Deviation 2.1 |
Secondary
Median Pain Score
Measured on a scale from 1 to 10 in the first 24 hours following the surgical procedure, 1=mild pain; 10=worst pain.
Time frame: 24 hours following the surgical procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low-Dose Bupivacaine | Median Pain Score | 3.4 score on a scale | Standard Deviation 1.9 |
| Mepivacaine | Median Pain Score | 3.4 score on a scale | Standard Deviation 1.6 |
Secondary
Orthostatic Hypotension
Number of participants to experience orthostatic hypotension following the surgical procedure.
Time frame: Time of discharge, approximately 1-2 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low-Dose Bupivacaine | Orthostatic Hypotension | 4 Participants |
| Mepivacaine | Orthostatic Hypotension | 6 Participants |
Secondary
Post-Anesthesia Care Unit (PACU) Length of Stay
Number of minutes subjects were admitted to PACU following the surgical procedure
Time frame: Time of discharge, approximately 1-2 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low-Dose Bupivacaine | Post-Anesthesia Care Unit (PACU) Length of Stay | 65.2 minutes | Standard Deviation 33.6 |
| Mepivacaine | Post-Anesthesia Care Unit (PACU) Length of Stay | 75.0 minutes | Standard Deviation 39.3 |
Secondary
Transient Neurologic Symptoms
Number of participants to report transient neurologic symptoms
Time frame: One week post-operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low-Dose Bupivacaine | Transient Neurologic Symptoms | 0 Participants |
| Mepivacaine | Transient Neurologic Symptoms | 0 Participants |
Secondary
Urinary Retention
Number of participants to experience urinary retention follow the surgical procedure.
Time frame: Time of discharge, approximately 1-2 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low-Dose Bupivacaine | Urinary Retention | 10 Participants |
| Mepivacaine | Urinary Retention | 10 Participants |