Mepivacaine vs Bupivacaine Spinal Anesthesia for TKA

Keywords

• knee arthroplasty
• spinal anesthesia
• same day discharge
• mepivacaine
• bupivacaine

Lead sponsor

Prisma Health-Upstate is the lead sponsor of 74 studies on the registry; 7 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 10 (83%) have results posted.

Study arms

• Active comparator
  Mepivacaine

  Standard dose of mepivacaine anesthesia (1.5% or 2%) for total knee arthroplasty procedure

  Drug: Mepivacaine

• Active comparator
  Bupivacaine

  Standard dose of hyperbaric bupivacaine anesthesia (0.75%) for total knee arthroplasty procedure

  Drug: Bupivacaine

Interventions

• DrugMepivacaine

  Patients will be administered a standard dose of mepivacaine 1.5% (4.5ml, 67.5mg) for total knee arthroplasty prior to surgery

• DrugBupivacaine

  Patients will be administered a standard dose of 0.75% hyperbaric bupivacaine (1.4ml, 10.5mg) for total knee arthroplasty prior to surgery

Primary outcomes

1. Same day discharge rate

   Whether a patient is discharged the same day their surgery occurred, or if they were required to stay overnight following surgery.

   Time frame: 24 hours

Secondary outcomes

1. Post-operative pain score as assessed by numeric rating scale (NRS)

   The NRS is a verbal pain scale that is evaluated on a scale of 0-10, with zero being no pain and 10 being 'the worst pain imaginable'. NRS pain scores will be collected while in the post-anesthesia care unit (PACU), at each physical therapy visit until discharge, and at 3 days post-operatively.

   Time frame: 3 days

2. Urinary retention as assessed by time at which patient can voluntarily void bladder post-operatively

   Urinary retention will be evaluated based on whether patient is able to voluntarily void their bladder post-operatively. Time at which patient is able to voluntarily void their bladder will be recorded.

   Time frame: 24 hours

3. Return of sensory and motor function as assessed by ability of patient to plantar and dorsiflex lower extremity

   Time until return to sensory and motor function will be evaluated based on whether patient is able to plantar or dorsiflex lower extremity after surgery. Motor and sensory function will be considered 'intact' if patient is able perform these motions after surgery. Motor function will be evaluated in the post-anesthesia care unit (PACU) and during hospital stay over the course of 24 hours post-operatively.

   Time frame: 24 hours

4. Post-operative nausea and vomiting as assessed by clinical documentation of nausea and vomiting post-operatively

   Nausea and vomiting will be evaluated based on the presence of clinical documentation of episodes of nausea and vomiting during hospital admission over the course of 24 hours.

   Time frame: 24 hours

5. Pain Medications as evaluated by medical morphine equivalents

   Post-operative medications will be documented by medical morphine equivalents of medications administered during hospital stay. Total medical morphine equivalents over the course of 24 hours post-operatively will be used to capture pain medication usage during admission.

   Time frame: 24 hours

6. Patient satisfaction levels as assessed by a 5-item Likert response scale

   Patient satisfaction levels will be captured using a 5-item Likert response scale with options of: 'very unsatisfied', 'unsatisfied', 'neutral', 'satisfied', and 'very satisfied' with respect to the type of anesthesia they received during their surgery. Satisfaction will be evaluated at Day 3 post-operative follow-up call.

   Time frame: 3 days