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Completed

NCT Number: NCT03838874

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

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.

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Key information

Age range

18 day and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-Dose Bupivacaine

Drug

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

Mepivacaine

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 12, 2019
Registry last updated
Aug 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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