Postoperative Pain clinical trials at UCSD

This will be a randomized comparison of continuous local anesthetic infusion with patient controlled boluses (PCA) to patient-titratable automated boluses with patient controlled boluses (PCA) for both infraclavicular and popliteal-sciatic perineural catheters. The overall goal is to determine the relationship between method of local anesthetic administration (continuous with PCA vs. titratable intermittent dosing with PCA) for these two perineural catheter locations and the resulting pain control. The investigators hypothesize that, compared with a traditional fixed, continuous basal infusion initiated prior to discharge, perineural local anesthetic administered with titratable automated boluses at a lower dose and a 5-hour delay following discharge will (1) provide at least noninferior analgesia during the period that both techniques are functioning; and, (2) will result in a longer overall duration of administration [dual primary end points].

Breast cancer is the most common type of cancer in women. Removal of the breast, called "mastectomy", is performed either when there is cancer-or an increased risk of cancer-in the breast. This can result in a lot of pain during the months after surgery. Opioids-"narcotics"-are the most common pain control method provided to patients; but they frequently do not relieve enough pain, have undesirable side effects like vomiting and constipation, and are sometimes misused which can lead to addiction. Mastectomy also frequently results in long-term pain which can interfere with physical and emotional functioning; and the more pain patients have immediately after surgery, the greater the risk of developing long-term pain. Numbing the nerves with local anesthetic can decrease the amount of short- and long-term pain experienced by patients, but even the longest types of these nerve blocks last for hours or days, and not the 1-2 months of pain typically following mastectomy. So, there is reason to believe that if the nerve blocks could be extended so that they last longer than the pain from surgery, short- and long-term pain might be avoided completely without the need for opioids. A prolonged nerve block may be provided by freezing the nerve using a technique called "cryoneurolysis". With cryoneurolysis and ultrasound machines, a small needle-like "probe" may be placed through anesthetized skin and guided to the target nerve to allow freezing. The procedure takes about 5 minutes for each nerve, involves little discomfort, has no side effects, and cannot be misused or become addictive. After 2-3 months, the nerve returns to normal functioning. The investigators have completed a small study suggesting that a single cryoneurolysis treatment may provide potent pain relief after mastectomy. The ultimate objectives of the proposed research study are to determine if temporarily freezing the nerves that go to the breast will decrease short-term pain, opioid use, physical and emotional dysfunction, and long-term pain following mastectomy when added to current and customary postoperative analgesics. The current project is a pragmatic, multicenter, randomized, triple-masked (investigators, participants, statisticians), sham/placebo-controlled, parallel-arm, human-subjects, post-market clinical trial to determine if cryoneurolysis is an effective non-opioid treatment for pain following mastectomy.