Mepivacaine vs Bupivacaine for Knee Replacement Surgery
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Prisma Health-Upstate
Must not be taking: Insulin, Anticoagulants, Narcotics
Disqualifiers: Bilateral TKAs, Diabetes, Renal insufficiency, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This study is a prospective, double-blind prospective randomized controlled trial comparing mepivacaine and bupivacaine spinal anesthesia for same-day discharge readiness following a unilateral primary elective TKA procedure.
Study data will be collected during the patient's hospital stay for their TKA procedure, and the primary outcome of same-day discharge readiness will be assessed the day of surgery. Patients will also be contacted at Day 3 post-op to assess for any complications, current level of pain, and pain medication utilization.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it excludes those using pre-operative narcotics, except for tramadol, and those with certain conditions like diabetes requiring insulin.
What data supports the effectiveness of the drugs Mepivacaine and Bupivacaine for knee replacement surgery?
Research shows that Mepivacaine provides greater stability in heart rate and blood pressure during surgery, requires less pain medication afterward, and allows patients to walk sooner compared to Bupivacaine. Mepivacaine also facilitates a quicker recovery due to its shorter duration of action.
12345Is Mepivacaine or Bupivacaine safe for use in humans?
Bupivacaine (also known as Marcaine) is generally safe when used in recommended doses for procedures like epidural anesthesia, with minimal side effects on mothers and newborns in obstetrics. Mepivacaine is considered a safe alternative to lidocaine for ambulatory procedures, with a lower incidence of transient neurologic symptoms (temporary nerve-related issues) than lidocaine.
678910How does the drug Mepivacaine differ from Bupivacaine for knee replacement surgery?
Mepivacaine is unique because it facilitates a faster recovery after knee replacement surgery compared to Bupivacaine, making it a potentially better option for patients who prioritize a quicker return to normal activities.
3581112Eligibility Criteria
This trial is for adults scheduled for knee replacement surgery who are healthy enough to be discharged on the same day. Participants must not have conditions that would interfere with spinal anesthesia or recovery, such as allergies to local anesthetics, bleeding disorders, infection at the injection site, or severe heart or neurological issues.Inclusion Criteria
I am 18 or older and scheduled for a first-time knee replacement.
I can walk at least 10 feet on my own without help.
Patient must be a candidate for same day discharge as determined by American Society of Anesthesiologists (ASA) Physical Status Classification I and II
Exclusion Criteria
I am scheduled for knee replacement surgery on both knees.
Workers' Compensation patient
I am allergic to or cannot take NSAIDs due to other medications I'm on.
+8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Patients receive either mepivacaine or bupivacaine spinal anesthesia during their total knee arthroplasty procedure
1 day
1 visit (in-person)
Immediate Post-operative Monitoring
Patients are monitored for same-day discharge readiness and post-operative recovery, including pain management and motor function assessment
24 hours
Follow-up
Participants are contacted at Day 3 post-op to assess for complications, pain levels, and medication usage
3 days
1 visit (virtual)
Participant Groups
The study compares two types of spinal anesthesia drugs: Mepivacaine and Bupivacaine. It's designed to see which one allows patients to be ready for discharge sooner after knee replacement surgery. Patients will be randomly assigned a drug without knowing which one they receive (double-blind).
2Treatment groups
Active Control
Group I: BupivacaineActive Control1 Intervention
Standard dose of hyperbaric bupivacaine anesthesia (0.75%) for total knee arthroplasty procedure
Group II: MepivacaineActive Control1 Intervention
Standard dose of mepivacaine anesthesia (1.5% or 2%) for total knee arthroplasty procedure
Bupivacaine is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Marcaine for:
- Local anesthesia for surgery
- Acute pain management
- Spinal anesthesia
🇪🇺 Approved in European Union as Marcaine for:
- Local anesthesia for surgery
- Acute pain management
- Spinal anesthesia
🇨🇦 Approved in Canada as Sensorcaine for:
- Local anesthesia for surgery
- Acute pain management
- Spinal anesthesia
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Prisma Health Patewood HospitalGreenville, SC
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Who Is Running the Clinical Trial?
Prisma Health-UpstateLead Sponsor
References
[The effects of carbonation on 2% mepivacaine in epidural anesthesia]. [2013]To evaluate the clinical effects of 2% carbonated mepivacaine in arthroscopic surgery of the knee.
Comparison of Mepivacaine 2% and Isobaric Bupivacaine 0.5% Spinal Anesthetics for Total Knee Arthroplasty. [2023]Spinal anesthesia is an option for patients during total knee arthroplasty (TKA) procedures. Spinal anesthesia can offer advantages and disadvantages to the patient's experience and outcomes. We conducted an evidence-based, quality improvement project comparing mepivacaine 2% and isobaric bupivacaine 0.5% and retrospectively assessed specific intraoperative and postoperative outcomes that were of interest to the staff at the hospital where the project was completed. Primary outcome measures of interest included intraoperative heart rate, blood pressure, vasopressor use, fluid resuscitation, postoperative pain scores, use of opioid analgesic medications, and time to ambulation after administration of the spinal anesthetic. Compared with patients receiving isobaric bupivacaine 0.5% (n = 30), patients receiving mepivacaine 2% (n = 30) had greater intraoperative hemodynamic stability (defined as heart rate and blood pressure maintained within 20% of baseline values) during the first 30 minutes after anesthetic administration (P < .05 for multiple time points). They also required less opioid medication for postoperative pain management (25 vs 50 mcg fentanyl) and were able to ambulate sooner after the procedure (mean [standard deviation], 452.2 [218.5] vs 681.0 [476.6] minutes; P = .006). In conclusion, mepivacaine 2% was the higher-performing local primary spinal anesthetic for patients undergoing TKA.
Time of return of neurologic function after spinal anesthesia for total knee arthroplasty: mepivacaine vs bupivacaine in a randomized controlled trial. [2022]Mepivacaine as an intermediate-length spinal anesthetic for rapid recovery in total knee arthroplasty (TKA) has not been fully described. We compared spinal mepivacaine vs bupivacaine for postoperative neurologic function in patients undergoing primary TKA.
Mepivacaine Versus Bupivacaine Spinal Anesthesia for Primary Total Joint Arthroplasty: A Systematic Review and Meta-Analysis. [2022]Mepivacaine is an intermediate acting amide local anesthetic that can be used for neuraxial anesthesia in total joint arthroplasty (TJA) with a shorter duration of action (1.5-2 hours) compared to the more commonly used local anesthetic bupivacaine. The purpose of this study was to perform a systematic review and meta-analysis comparing bupivacaine and mepivacaine spinal anesthesia during elective TJA and the surgical outcomes of the time to full neurologic motor return, pain, mobility, length of stay (LOS), and complications including transient neurologic symptoms and urinary function.
Mepivacaine Spinal Anesthesia Facilitates Rapid Recovery in Total Knee Arthroplasty Compared to Bupivacaine. [2022]Mepivacaine as a spinal anesthetic for rapid recovery in total knee arthroplasty (TKA) has not been assessed. The purpose of this study is to compare spinal mepivacaine vs bupivacaine for postoperative measures in patients undergoing primary TKA.
[The use of Marcaine in obstetrical analgesia]. [2013]Bupivacaine (Marcaine) is being used increasingly in obstetrics for epidural analgesia, by virtue of the good sensory block obtained and the minimum of side-effects on the mother and newborn infant. At a concentration of less than 0.5 p. 100, analgesia is excellent with a minimal effect on motor fibres. Side-effects and toxicity are limited by the use of fractionated doses from the beginning of labour or of a single dose during or at the end of labour calculated in relation to the effect sought. Any action on the newborn infant would appear to be exceptional, if dose recommendations are respected, the high percentage of Marcaine bound to proteins limiting its transplacental passage.
Clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor in oral implantology. [2019]Bupivacaine (Marcaine), homologue of mepivacaine, chemically related to lidocaine, is used as a local anesthetic for local infiltration, peripheral nerve block, retrobulbar block, symphathetic block, and caudal and epidural anesthesia. The aim of this investigation was to determine and to compare clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor.
[Peridural analgesic therapy in orthopedic surgery: comparison of ropivacaine and bupivacaine]. [2018]The aim of our study was to compare the efficiency of ropivacaine and bupivacaine, in epidural administration, in postoperative analgesia. 20 patients, undergone knee surgery, in epidural anaesthesia (bupivacaine 0.5%-2 mg/Kg-1 administered in level L3L4), was divided into 2 groups (10 each one) and the local anaesthetics in study was administered by epidural catheter with an elastomeric pump: A (ropivacaine 0.15%) and B (bupivacaine 0.15%). The results demonstrate that ropivacaine is better than bupivacaine to keep a check on analgesia in postoperative pain.
Dose response relationships for isobaric spinal mepivacaine using the combined spinal epidural technique. [2022]Mepivacaine, a local anesthetic with similar physiochemical properties to those of lidocaine, is an adequate alternative for patients undergoing ambulatory procedures, and is associated with a lower incidence of transient neurologic symptoms (TNS) than lidocaine. We studied the dose-response characteristics of isobaric intrathecal mepivacaine using the combined spinal epidural technique for patients undergoing ambulatory arthroscopic surgery of the knee. Seventy-five patients were randomized prospectively to receive one of three doses of isobaric mepivacaine for spinal anesthesia: 30 mg (2 mL 1.5%), 45 mg (3 mL 1.5%), or 60 mg (4 mL 1.5%). An observer, blinded to the dose, recorded sensory level to pinprick and motor response until resolution of the block. In addition, the incidence of TNS was determined. An initial intrathecal dose of 30 mg of isobaric mepivacaine 1.5% produced satisfactory anesthesia in 72% of ambulatory surgical patients undergoing unilateral knee arthroscopy with a significantly shorter duration of sensory (158 +/- 32 min) and motor blockade (116 +/- 38 min) than doses of 45 and 60 mg. An intrathecal dose of 45 mg produced satisfactory anesthesia in all patients with a shorter duration of sensory (182 +/-38 min) and motor blockade (142 +/- 37 min) than 60 mg of mepivacaine 1.5% (203 +/- 36 min and 168 +/- 36 min, respectively). The incidence of TNS was 7.4% overall (1.2%-13.6% confidence intervals), less than the rates previously reported after spinal anesthesia with lidocaine in ambulatory surgical patients undergoing knee arthroscopy. We conclude that mepivacaine can be used as an adequate alternative to lidocaine for ambulatory procedures.
[A clinical trial of the use of 2 forms of bupivacaine hydrochloride (Anecaine and Marcaine) for epidural anesthesia]. [2013]Two forms of 0.5% bupivacaine hydrochloride, Anecaine (Pliva) (n = 15) and Marcaine (Astra) (n = 15) were used for epidural anesthesia. The clinical picture of conduction block induced by the two local anesthetics varied. It manifested by a shorter latent period of analgesia development at the level of catheter and the drug infusion (LII) and relatively delayed development of analgesia in peripheral zones for Anecaine in comparison with marcaine. The authors conclude that solutions of local anesthetics containing the same active agent in the same concentrations under different commercial names manufactured by different companies may be characterized by different clinical picture of conduction blockade.
Mepivacaine Versus Bupivacaine in Adult Surgical Patients: A Meta-analysis, Trial Sequential Analysis of Randomized Controlled Trials. [2023]Evidence supporting the choice between mepivacaine and bupivacaine is inconclusive. This meta-analysis aims to determine whether mepivacaine can reach a similar effect to bupivacaine after surgeries.
Intra-articular local anaesthetic on the day after surgery improves pain and patient satisfaction after Unicompartmental Knee Replacement: a randomised controlled trial. [2013]Intra-operative local anaesthetic infiltration provides good early pain relief after Unicompartmental Knee Replacement (UKR). However, appreciable pain may occur on the day after surgery. The purpose of this double-blinded, prospective randomised controlled trial was to evaluate the effectiveness of a bolus of local intra-articular anaesthetic given early on the day after surgery. Forty-four patients were randomised to receive an intra-articular injection, via an epidural catheter inserted at operation, of either 20 ml 0.5% plain bupivacaine or 20 ml normal saline. All patients received a femoral nerve block with 20 ml prilocaine 1% and local anaesthetic infiltration by the surgeon. Patients injected with bupivacaine had significantly less (p