Evaluation of Fixed Intrathecal Bupivacaine Infusion Doses in the Oncologic Population.

OBJECTIVES: Intrathecal drug delivery systems (IDDS) are an important method of pain control for patients with refractory oncologic pain. Local anesthetics such as bupivacaine have been infused either alone or with opioids. While effective, bupivacaine can cause adverse effects such as numbness, weakness, and urinary retention. This study looks to establish a safe and efficacious fixed bupivacaine dosing algorithm in intrathecal pumps for cancer patients. MATERIALS AND METHODS: A bupivacaine dosing algorithm was developed using data from 120 previous patients who underwent IDDS placement at Memorial Sloan Kettering Cancer Center. The outcomes were then evaluated for 43 subsequent patients who were treated with bupivacaine IDDS according to our aforementioned algorithm. RESULTS: Our data show that in patients treated with our bupivacaine guideline, visual analog pain scale scores decreased by 59% and oral morphine equivalence decreased by 70% from the period between IDDS implantation until discharge from the MSKCC hospital. However, 16.3% of our patients had bupivacaine-related side effects. CONCLUSIONS: For oncological patients, our data and experience support the initiation of intrathecal bupivacaine at the following doses: 5 mg/day for catheter tips in the cervical spine, 8 mg/day for catheter tips at T1-4, and 10 mg/day for catheter tips at T5-8. Given the higher likelihood of adverse effects in catheters at T9-12 and the lumbar spine, we start at 8 mg/day with close follow-up of the patient. Initiating these doses allow our patients to safely reach adequate analgesia faster, with a shorter hospitalization and quicker return to anti-cancer therapy.

A Prospective, Randomized, Masked, and Placebo-Controlled Efficacy Study of Intraarticular Allogeneic Adipose Stem Cells for the Treatment of Osteoarthritis in Dogs.

Osteoarthritis (OA) is a degenerative joint disease with a high prevalence in dogs. Mesenchymal stem cells (MSCs) have been used to treat humans, dogs, and horses with OA. This report describes a prospective, randomized, blinded, and placebo-controlled clinical efficacy study of intraarticular allogeneic adipose stem cells for the treatment of dogs with OA. Health assessments and measurements of pain and activity impairment were performed at baseline and at selected time points through day 60. The primary outcome variable was the owner Client-Specific Outcome Measurement (CSOM) and secondary measures included veterinary pain on manipulation, veterinary global score, and owner global score. The dogs were treated with either a saline placebo or a single dose of allogeneic adipose-derived MSCs in either one or two joints. Seventy-four dogs were statistically analyzed for efficacy outcomes. Success in the primary outcome variable, CSOM, was statistically improved in the treated dogs compared to the placebo dogs (79.2 versus 55.4%, p = 0.029). The veterinary pain on manipulation score (92.8 versus 50.2%, p = 0.017) and the veterinary global score (86.9 versus 30.8%, p = 0.009) were both statistically improved in treated dogs compared to placebo. There was no detected significant difference between treated and placebo dogs in the incidence of adverse events or negative health findings. Allogeneic adipose-derived stem cell treatment was shown to be efficacious compared to placebo. This large study of dogs also provides valuable animal clinical safety and efficacy outcome data to our colleagues developing human stem cell therapy.