Phase 3
N=154
Mepivacaine Versus Low-Dose Bupivacaine For Primary Total Hip and Knee Arthroplasty
Knee Osteoarthritis · Hip Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT03838874 ↗Enrolled (actual)
154
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Time to Return of Lower Extremity Motor Function — 210.3; 184.7 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Low-Dose Bupivacaine (Drug); Mepivacaine (Drug)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Return of Lower Extremity Motor Function |
210.3; 184.7 | — |
| SECONDARY Post-Anesthesia Care Unit (PACU) Length of Stay |
65.2; 75.0 | — |
| SECONDARY Hospital Length of Stay |
1.5; 1.4 | — |
| SECONDARY Maximum Pain Score |
6.0; 6.5 | — |
| SECONDARY Median Pain Score |
3.4; 3.4 | — |
| SECONDARY Discharge Pain Score |
3.5; 3.5 | — |
| SECONDARY Orthostatic Hypotension |
4; 6 | — |
| SECONDARY Urinary Retention |
10; 10 | — |
| SECONDARY Transient Neurologic Symptoms |
0; 0 | — |
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.
Eligibility Criteria
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 ( 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) 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
Data sourced from ClinicalTrials.gov (NCT03838874). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.