Discussion
abnormal mental reaction, erythema, hypotension, abnormal ST-segment electrocardiogram, ODD
ADVERSE REACTIONS, INFILTRATION, LOCAL INFILTRATION, ADVERSE EVENTS, INFILTRATE, ERYTHEMA, HYPERTRIGLYCERIDEMIA
An injectable oil delivery depot (ODD) is a classic oily drug delivery system that is a vehicle for hormone or psychotropic drugs. Previous clinical studies have examined the application of ODD in the field of anesthesia, such as the formulation of ropivacaine with castor oil and phospholipids. However, the high levels of irritation and sensitization associated with castor oil are causes for concern [RODD was allowed for further clinical studies in healthy subjects after evaluation in animal studies. In exploratory studies, there was slight local irritation at a single infiltration dose of RODD 24 mg. Local irritation slightly increased after multineedle subcutaneous administration. In most cases, it was relieved after 24 h and disappeared after 72 h. It was speculated that the local irritation might be related to the overlapping infiltration range of two adjacent needles. The incidence of RODD-related adverse events was mild, including hypotension, abnormal ST-segment electrocardiogram, and hypertriglyceridemia, which returned to normal 72 h after administration. In addition, two subjects in the RHI group had mild erythema in the administered area, and one subject had hypertriglyceridemia, which quickly disappeared. These transient and mild adverse reactions may be caused by ropivacaine, excipients, frequent clinical administration, or topical disinfectants. In addition, no abnormal mental reaction was observed. Therefore, RODD was demonstrated to be safe. The results support the follow-up study of subcutaneous administration of analgesia in patients.The preliminary pharmacodynamic assessment of RODD was divided into two parts. The recommended amount of RODD in single-needle administration was 24 mg in the exploratory experiment, the duration of analgesia was approximately 12 h, and the injection range was approximately 40 mm. The circle on the abdomen of the subject was uniformly administered with 6 needles in the 400 mg RODD group, the distance between two adjacent needles was 20 mm, and the subcutaneous injection range overlapped each other, suggesting that the anesthesia time of RODD multipoint injection was further prolonged. The efficacy of local infiltration of RHI has been reported [The concentration-time curves of ropivacaine for RODD were significantly different from those for RHI. The RHI curve rose rapidly after administration, and the curve decreased rapidly after 0.77 h (TPharmacokinetic studies of RODD showed that the TCompared with the report of RHI [The results of the preclinical safety evaluation demonstrated that RODD does not interfere with incision healing in the abdomen and back of mini-pigs. However, RODD was not used to infiltrate the patient’s incision after surgery, and the safety and effect of RODD need to be verified by experiments, including the dose of RODD in patients with incision infiltration and the distance between the two injection sites, as well as the distance from the injection site to the incision, which should be studied; whether the injection of RODD affects the wound healing of patients after surgery and the occurrence of related adverse events; whether the duration of analgesia is similar to that of healthy subjects; and whether RODD is used for surgical incisions in other parts of the body except the abdomen. How strong is the analgesic effect? At present, we are designing a program to evaluate the analgesic effect and safety of endoscopic incision of RODD in the abdomen of patients, and these indicators have been given priority consideration.The release mechanism in ODD has also been studied. For instance, Kalicharan et al. reported the metabolism of ODD in different tissues and measured its spatial distribution by magnetic resonance imaging technology to visualize the changes in ODD 