Mepivacaine Versus Low-Dose Bupivacaine For Primary Total Hip and Knee Arthroplasty

NCT03838874 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 18-008635
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Hip Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Post-Anesthesia Care Unit (PACU) Length of Stay

  Time of discharge, approximately 1-2 days

• Hospital Length of Stay

  Time of discharge, approximately 1-2 days

• Maximum Pain Score

  24 hours following the surgical procedure

• Median Pain Score

  24 hours following the surgical procedure

• Discharge Pain Score

  Time of discharge, approximately 1-2 days

Study Arms (2)

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.

Drug: Low-Dose Bupivacaine

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.

Drug: Mepivacaine

Interventions

Low-Dose Bupivacaine DRUG

10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic

Low-Dose Bupivacaine

Mepivacaine DRUG

70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic

Mepivacaine

Eligibility Criteria

• Age: 18 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• + years of age
• Able to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Interventions

Bupivacaine; Mepivacaine

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Matthew Abdel
• Organization: Mayo Clinic

Abdel.Matthew@mayo.edu

507-538-1296

Study Officials

• Matthew P Abdel, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 12, 2019
• Study Start: February 25, 2019
• Primary Completion: October 29, 2019
• Study Completion: October 29, 2019
• Last Updated: August 12, 2021
• Results First Posted: August 12, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)