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

Primary Purpose

Knee Osteoarthritis, Hip Osteoarthritis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Low-Dose Bupivacaine
Mepivacaine
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

18 Days - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Low-Dose Bupivacaine

Mepivacaine

Arm Description

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.

Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Post-Anesthesia Care Unit (PACU) Length of Stay
Number of minutes subjects were admitted to PACU following the surgical procedure
Hospital Length of Stay
Number days subjects were admitted to the hospital following the surgical procedure
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.
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.
Discharge Pain Score
Measured on a scale from 1 to 10 at time of hospital discharge, 1=mild pain; 10=worst pain.
Orthostatic Hypotension
Number of participants to experience orthostatic hypotension following the surgical procedure.
Urinary Retention
Number of participants to experience urinary retention follow the surgical procedure.
Transient Neurologic Symptoms
Number of participants to report transient neurologic symptoms

Full Information

First Posted
February 11, 2019
Last Updated
July 20, 2021
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03838874
Brief Title
Mepivacaine Versus Low-Dose Bupivacaine For Primary Total Hip and Knee Arthroplasty
Official Title
Double Blind Randomized Clinical Trial Comparing Time To Return of Lower Extremity Motor Function Following Spinal Anesthetic With Mepivacaine Versus Low-Dose Bupivacaine For Primary Total Hip and Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 25, 2019 (Actual)
Primary Completion Date
October 29, 2019 (Actual)
Study Completion Date
October 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Hip Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-Dose Bupivacaine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Mepivacaine
Arm Type
Active Comparator
Arm Description
Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA.
Intervention Type
Drug
Intervention Name(s)
Low-Dose Bupivacaine
Intervention Description
10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic
Intervention Type
Drug
Intervention Name(s)
Mepivacaine
Intervention Description
70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic
Primary Outcome Measure Information:
Title
Time to Return of Lower Extremity Motor Function
Description
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
Secondary Outcome Measure Information:
Title
Post-Anesthesia Care Unit (PACU) Length of Stay
Description
Number of minutes subjects were admitted to PACU following the surgical procedure
Time Frame
Time of discharge, approximately 1-2 days
Title
Hospital Length of Stay
Description
Number days subjects were admitted to the hospital following the surgical procedure
Time Frame
Time of discharge, approximately 1-2 days
Title
Maximum Pain Score
Description
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
Title
Median Pain Score
Description
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
Title
Discharge Pain Score
Description
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
Title
Orthostatic Hypotension
Description
Number of participants to experience orthostatic hypotension following the surgical procedure.
Time Frame
Time of discharge, approximately 1-2 days
Title
Urinary Retention
Description
Number of participants to experience urinary retention follow the surgical procedure.
Time Frame
Time of discharge, approximately 1-2 days
Title
Transient Neurologic Symptoms
Description
Number of participants to report transient neurologic symptoms
Time Frame
One week post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Days
Accepts Healthy Volunteers
No
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 (< 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew P Abdel, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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

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