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

• ClinicalTrials.gov Identifier: NCT03838874
• Recruitment Status: Completed
• First Posted: February 12, 2019
• Results First Posted: August 12, 2021
• Last Update Posted: August 12, 2021
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): Matthew P. Abdel, M.D., Mayo Clinic

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.

Condition or disease	Intervention/treatment	Phase
Knee Osteoarthritis; Hip Osteoarthritis	Drug: Low-Dose Bupivacaine; Drug: Mepivacaine	Phase 2; Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 154 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: February 25, 2019
• Actual Primary Completion Date: October 29, 2019
• Actual Study Completion Date: October 29, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	Drug: Low-Dose Bupivacaine; 10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic
Active Comparator: Mepivacaine; 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; 70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic

Outcome Measures

Primary Outcome Measures :

1. Time to Return of Lower Extremity Motor Function [ Time Frame: Post surgery, approximately 1 day ]
   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 :

1. Post-Anesthesia Care Unit (PACU) Length of Stay [ Time Frame: Time of discharge, approximately 1-2 days ]
   Number of minutes subjects were admitted to PACU following the surgical procedure
2. Hospital Length of Stay [ Time Frame: Time of discharge, approximately 1-2 days ]
   Number days subjects were admitted to the hospital following the surgical procedure
3. Maximum Pain Score [ Time Frame: 24 hours following the surgical procedure ]
   Measured on a scale from 1 to 10 in the first 24 hours following the surgical procedure, 1=mild pain; 10=worst pain.
4. Median Pain Score [ Time Frame: 24 hours following the surgical procedure ]
   Measured on a scale from 1 to 10 in the first 24 hours following the surgical procedure, 1=mild pain; 10=worst pain.
5. Discharge Pain Score [ Time Frame: Time of discharge, approximately 1-2 days ]
   Measured on a scale from 1 to 10 at time of hospital discharge, 1=mild pain; 10=worst pain.
6. Orthostatic Hypotension [ Time Frame: Time of discharge, approximately 1-2 days ]
   Number of participants to experience orthostatic hypotension following the surgical procedure.
7. Urinary Retention [ Time Frame: Time of discharge, approximately 1-2 days ]
   Number of participants to experience urinary retention follow the surgical procedure.
8. Transient Neurologic Symptoms [ Time Frame: One week post-operative ]
   Number of participants to report transient neurologic symptoms

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Minnesota

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

Investigators

• Principal Investigator: Matthew P Abdel, MD; Mayo Clinic

  Study Documents (Full-Text)

Documents provided by Matthew P. Abdel, M.D., Mayo Clinic:

Study Protocol and Statistical Analysis Plan  [PDF] September 3, 2018

More Information

Additional Information:

Mayo Clinic Clinical Trials 

• Responsible Party: Matthew P. Abdel, M.D., Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT03838874
• Other Study ID Numbers: 18-008635
• First Posted: February 12, 2019
• Results First Posted: August 12, 2021
• Last Update Posted: August 12, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bupivacaine; Mepivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents