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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-Dose Bupivacaine | Active Comparator | 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. |
|
| Mepivacaine | Active Comparator | Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-Dose Bupivacaine | Drug | 10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post surgery, approximately 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Post-Anesthesia Care Unit (PACU) Length of Stay | Number of minutes subjects were admitted to PACU following the surgical procedure | Time of discharge, approximately 1-2 days |
| Hospital Length of Stay |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Matthew P Abdel, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Mepivacaine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | minutes | Post surgery, approximately 1 day |
|
Adverse events were collected from baseline to end of study for a total of approximately 6-9 days on all participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matthew Abdel | Mayo Clinic | 507-538-1296 | Abdel.Matthew@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 3, 2018 | Jun 30, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D008619 | Mepivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Mepivacaine | Drug | 70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic |
|
Number days subjects were admitted to the hospital following the surgical procedure
| Time of discharge, approximately 1-2 days |
| 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. | 24 hours following the surgical procedure |
| 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. | 24 hours following the surgical procedure |
| Discharge Pain Score | Measured on a scale from 1 to 10 at time of hospital discharge, 1=mild pain; 10=worst pain. | Time of discharge, approximately 1-2 days |
| Orthostatic Hypotension | Number of participants to experience orthostatic hypotension following the surgical procedure. | Time of discharge, approximately 1-2 days |
| Urinary Retention | Number of participants to experience urinary retention follow the surgical procedure. | Time of discharge, approximately 1-2 days |
| Transient Neurologic Symptoms | Number of participants to report transient neurologic symptoms | One week post-operative |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Post-Anesthesia Care Unit (PACU) Length of Stay | Number of minutes subjects were admitted to PACU following the surgical procedure | Posted | Mean | Standard Deviation | minutes | Time of discharge, approximately 1-2 days |
|
|
|
| Secondary | Hospital Length of Stay | Number days subjects were admitted to the hospital following the surgical procedure | Posted | Mean | Standard Deviation | days | Time of discharge, approximately 1-2 days |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 24 hours following the surgical procedure |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 24 hours following the surgical procedure |
|
|
|
| Secondary | Discharge Pain Score | Measured on a scale from 1 to 10 at time of hospital discharge, 1=mild pain; 10=worst pain. | Posted | Mean | Standard Deviation | score on a scale | Time of discharge, approximately 1-2 days |
|
|
|
| Secondary | Orthostatic Hypotension | Number of participants to experience orthostatic hypotension following the surgical procedure. | Posted | Count of Participants | Participants | Time of discharge, approximately 1-2 days |
|
|
|
| Secondary | Urinary Retention | Number of participants to experience urinary retention follow the surgical procedure. | Posted | Count of Participants | Participants | Time of discharge, approximately 1-2 days |
|
|
|
| Secondary | Transient Neurologic Symptoms | Number of participants to report transient neurologic symptoms | Posted | Count of Participants | Participants | One week post-operative |
|
|
|
| 0 |
| 80 |
| 0 |
| 80 |
| 0 |
| 80 |
| EG001 | 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 | 0 | 74 | 0 | 74 | 0 | 74 |
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| D012216 |
| Rheumatic Diseases |
| D000588 |
| Amines |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |