As a clinician I hope you are sharing this information with your surgeons. I am happy for your success however different modalities offer surgeons options. Why is it so hard to work together and ensure the patient has the best outcome always?
8.2 Adverse Reactions Reported in All Wound Infiltration Clinical Studies
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
The safety of bupivacaine liposome suspension was evaluated in 10 randomized, double-blind, local administration into the surgical site clinical studies involving 823 patients undergoing various surgical procedures. Patients were administered a dose ranging from 66 to 532 mg of bupivacaine liposome suspension. In these studies, the most common adverse reactions (incidence greater than or equal to 10%) following bupivacaine liposome suspension administration were nausea, constipation, and vomiting.
The common adverse reactions (incidence greater than or equal to 2% to less than 10%) following bupivacaine liposome suspension administration were pyrexia, dizziness, edema peripheral, anemia, hypotension, pruritus, tachycardia, headache, insomnia, anemia postoperative, muscle spasms, hemorrhagic anemia, back pain, somnolence, and procedural pain.
The less common/rare adverse reactions (incidence less than 2%) following bupivacaine liposome suspension administration were chills, erythema, bradycardia, anxiety, urinary retention, pain, edema, tremor, dizziness postural, paresthesia, syncope, incision site edema, procedural hypertension, procedural hypotension, procedural nausea, muscular weakness, neck pain, pruritus generalized, rash pruritic, hyperhidrosis, cold sweat, urticaria, bradycardia, palpitations, sinus bradycardia, supraventricular extrasystoles, ventricular extrasystoles, ventricular tachycardia, hypertension, pallor, anxiety, confusional state, depression, agitation, restlessness, hypoxia, laryngospasm, apnea, respiratory depression, respiratory failure, body temperature increased, blood pressure increased, blood pressure decreased, oxygen saturation decreased, urinary retention, urinary incontinence, vision blurred, tinnitus, drug hypersensitivity, and hypersensitivity.
Neurological and Cardiac Adverse Reactions Reported in All Wound Infiltration Clinical Studies
In the bupivacaine liposome suspension wound infiltration studies, adverse reactions with an incidence greater than or equal to 1% in the Nervous System Disorders system organ class following bupivacaine liposome suspension administration were dizziness (6.2%), headache (3.8%), somnolence (2.1%), hypoesthesia (1.5%), and lethargy (1.3%). The adverse reactions with an incidence greater than or equal to 1% in the Cardiac Disorders system organ class following bupivacaine liposome suspension administration were tachycardia (3.9%) and bradycardia (1.6%).
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