Mepivacaine vs. Bupivacaine Spinal Anesthetic in Total Knee Arthroplasty

NCT02980926 | Completed Phase 4

• 1 other identifier: #10455
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if a shorter-acting spinal anesthetic called mepivacaine has advantages over a longer-acting medication called bupivacaine.

Conditions

Anesthesia, Spinal; Arthroplasty, Replacement, Knee; Pain Management; Early Ambulation; Ambulatory Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• Return of motor and sensory function

  Times will be recorded in minutes from the administration of the spinal anesthetic. Normal exam will include intact sensation to light touch of the thigh, calf, foot and toes. Normal motor is defined as ability to perform a straight leg raise, active knee flexion, as well as wiggling of the ankle and toes.

  Exams will take place in 15 minute intervals beginning with arrival to the PACU and will be continued for a maximum of 6 hours or until the exam returns to baseline for 2 consecutive exams.

Secondary Outcomes (7)

• Pain

  Entire hospital admission. No data will be recorded after 96 hours.

• Pain

  Hospital admission, maximum of 96 hours.

• Time to urination

  24 hours maximum from time of spinal.

• Urinary retention

  Entire hospital stay beginning immediately in the post operative period until discharge to a maximum of 96 hours.

• Length of stay

  Hospital admission maximum of 96 hours.

Study Arms (2)

Mepivacaine Spinal Anesthetic

EXPERIMENTAL

Mepivacaine 3 mL intrathecal injection of 2% solution

Drug: Mepivacaine

Bupivacaine Spinal Anesthetic

ACTIVE COMPARATOR

Bupivacaine 12 mg of 8.25% solution

Drug: Bupivacaine

Interventions

Mepivacaine DRUG

This is a shorter acting spinal anesthetic as compared to the current standard of care at this institution.

Also known as: CAS Number: 96-88-8, Carbocaine

Mepivacaine Spinal Anesthetic

Bupivacaine DRUG

This is the current standard of care at this institution and many centers. This is a longer acting spinal anesthetic compared to the study drug.

Also known as: Sensorcaine, Marcaine, CAS 38396-39-3

Bupivacaine Spinal Anesthetic

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients undergoing primary total knee arthroplasty

You may not qualify if:

• Chronic opioid users
• Unable to give informed consent
• Forego the use of a foley catheter
• Those with hypersensitively to amide local anesthetics or opioids
• Those with contraindications to spinal anesthesia
• Conversion to general anesthesia will be excluded.

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford West Bloomfield

West Bloomfield, Michigan, 48322, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Mepivacaine; Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jason Davis, MD

  Surgeon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PGY-3

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: December 2, 2016
• Study Start: December 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: March 27, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)