The purpose of this study is to find a better way to make patients comfortable after their knee surgery. The investigators compared three ways of providing pain relief, either by use of a nerve block at the femoral and sciatic nerve areas, or with actual injections in the surgical joint area with one of two different medicines, either ropivacaine or liposomal bupivacaine (Exparel®). The hypothesis was that the nerve block at the femoral and sciatic nerve areas would result in lower pain scores and opioid consumption than either of the two injections in the surgical joint area.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
165
Subjects received Bupivacaine 0.5% preoperatively, then Bupivacaine 0.2% upon post anesthesia care unit (PACU) arrival via femoral nerve block, then Bupivacaine 0.25% via single-injection sciatic nerve.
Subjects received an intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Ropivacaine dose depended upon body weight: 50-74.9 kg: 200 mg, 75-99.9 kg: 300 mg, 100-125 kg: 400 mg.
Subjects received an intra articular injection with liposomal bupivacaine, a total volume of 120 mL injected in the periarticular structures by the surgeon. Patients weighing 50-125 kg received 266mg of Liposomal Bupivacaine.
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Maximum Pain Post-Operative Day (POD) 1 (Morning)
Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.
Time frame: Post-Operative Day 1, approximately 6 am to 12:00 pm
Average Pain Post-Postanesthesia Care Unit (PACU)
Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.
Time frame: Post-operative Day 0, approximately 12 pm to 12 am
Maximum Pain Post-PACU
Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.
Time frame: Post-operative Day 0, approximately 12 pm to 12 am
Average Pain POD 1 (24 Hours)
Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.
Time frame: POD 1, approximately 12 am to 12 am next day
Maximum Pain POD 1 (24 Hours)
Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.
Time frame: POD 1, approximately 12 am to 12 am next day
Average Pain POD 2 (24 Hours)
Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.
Time frame: POD 2, approximately 12 am to 12 am next day
Maximum Pain POD 2 (24 Hours)
Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.
Time frame: POD 2, approximately 12 am to 12 am next day
Preoperative Daily Opioid Use
Opioid consumption will be documented in the patient electronic medical record by the nursing staff caring for the patient.
Time frame: baseline
Intraoperative Opioid Use
Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.
Time frame: During the procedure, approximately 2 hours after start of the procedure
PACU Opioid Use
Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.
Time frame: Approximately 2 hours after entry in PACU
POD 0 Post-PACU Opioid Use
Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.
Time frame: POD 0, approximately 12 pm to 12 am
POD 1 Opioid Use
Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.
Time frame: POD 1, approximately 12 am to 12 am next day
POD 2 Opioid Use
Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.
Time frame: POD 2, approximately 12 am to 12 am next day
Hospital Length of Stay
The hospital length of stay was measured from the date of admittance until the date of discharge.
Time frame: Approximately 3 days
Balance Testing on Operative Leg Using Unipedal Stance Time
In order to measure clinical balance, unipedal stance time (UST) was collected as an indicator of balance and fall risk. Timing (in seconds) began upon withdrawal of support and continued until the uplifted foot returned to the floor, the subject required support, or if the subject reached a time limit of 30 seconds. The best performance of three repetitions was recorded for analysis. Normative values for the UST are available. A UST threshold of 30 seconds yields a sensitivity of 95% and a specificity of 58% in identifying those with a history of falls. The first five seconds of unipedal stance is indicative of dynamic balance; inability to maintain unipedal stance for five seconds is a significant predictor of injurious falls.
Time frame: baseline, approximately 12 weeks
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