3 Clinical Trials for Various Conditions
Primary Objective: • To describe postoperative static pain scores on the Pain Visual Analog Scale at Day 1 in a population of women undergoing bilateral mastectomy followed by immediate, bilateral pre-pectoral tissue expander breast reconstruction reinforced with AlloDerm® coverage. Secondary Objectives: * To describe postoperative static and dynamic pain scores on the Pain Visual Analog Scale and Brief Pain Inventory-Short Form at Day 1-60 after tissue expander placement * To describe nausea/vomiting, and opioid use at Day 1, 2, 3, 7, 30, and 60 after mastectomy and tissue expander placement. * To describe short-term changes in Quality of Life scores after mastectomy and tissue expander placement. * To describe postoperative complication rates at Day 1, 2, 3, 7, 30, and 60 after mastectomy and tissue expander placement. * To describe nausea/vomiting, and opioid use at Day 1, 2, 3, 7, 30, and 60 after final reconstruction with tissue expander exchange for permanent implant. * To describe short-term changes in Quality of Life scores after final reconstruction with tissue expander exchange for permanent implant. * To describe postoperative complication rates at Day 1, 2, 3, 7, 30, and 60 after final reconstruction with tissue expander exchange for permanent implant. * To describe postoperative rates of breast animation deformity at Day 7, 30, and 60 after final reconstruction with tissue expander exchange for permanent implant. * To describe average hospital length of stay in patients after final reconstruction with tissue expander exchange for permanent implant. * To describe the patient's final assessment of pre-pectoral reconstruction from free-form text. Tertiary Objectives: • To measure cosmetic result and associated residual pain with Alloderm® reinforcement of breast pocket.
ERBEjet Breast augmentation is a novel method of dissection of the subpectoral pocket. Study is designed to differentiate parameters of pain between randomized laterality using no touch technique. THIS IS NOT A FREE STUDY. Patients are required to pay the initial cost of surgery but will receive a refund of a partial payment. Patients must undergo evaluation at consultation and surgical quote is provided.
The investigators hypothesize that in mastectomy patients with breast reconstruction, the addition of bupivacaine and botulinum toxin (BT) will result in better pain control in the acute and chronic setting, compared to traditional pain management techniques which rely almost exclusively on opioid analgesics and sedatives like diazepam (valium). This expectation is based on the fact that bupivacaine produces pre-emptive analgesia and BT will produce muscle relaxation, the combination of which will target different sites of pain generation, thus producing better analgesia. We also hypothesize that additional benefits may accrue from this regimen including decreased nausea and vomiting, sedation and constipation as a result of diminished opioid use1.