A new medication called Exparel produced by Pacira Pharmaceuticals provides an alternative to opioids for use as pain relief following wisdom teeth removal. Exparel is a long-acting local anesthetic that is delivered during the surgery that numbs the site of surgery for up to three days. Exparel is not an opioid and is not habit forming and therefore will not lead to any opioid addiction. Many patients are already familar with local pain analgesics such as lidocaine that are given as a dental injection to numb an area for several hours. Exparel is a long lasting analgesics which seems to share some similarities but lasts much longer.
Recently the use of opioids after wisdom teeth removal has been more closely scrutinzed, see for example http://blog.teethremoval.com/opioid-prescriptions-from-dental-clinicians-for-young-adults-and-subsequent-opioid-use-and-abuse/ and http://blog.teethremoval.com/persistent-opioid-use-after-wisdom-teeth-removal. Many are concerned that patients having wisdom teeth surgery are exposed to opioids for he first time and this may set them on a course of later addiction. As a result some oral surgeons are now switching to using Exparel instead of opioids. The article titled “Idaho Doctor turns to opioid-alternative for patients’ post-surgery pain,” by WQAD published May 15, 2018, describes an Idaho oral surgeon who has been giving his patients having wisdom teeth removed Exparel. He hopes that long lasting local anesthetics will become standard practice among oral surgeons to help cut back on the number of opioid prescriptions given to young patients after wisdom teeth removal.
In a study titled “Liposomal Bupivacaine Use in Third Molar Impaction Surgery: INNOVATE Study” by S. Lieblich and H. Danesi appearing in Anesth. Prog. vol. 64, pp.127–135, 2017, the use of Exparel for patients undergoing wisdom teeth removal is evaluated in a phase 3, double-blind, placebo-controlled study. In this study 162 patients received either liposomal bupivacaine or placebo. However, 73 of these patients had major protocol violations as defined by the authors and thus only 59 patients receiving liposomal bupivacaine and 30 patients receiving placebo were included in the final study participants.
Looking at the groups in the above mentioned study groups that did not have any major violations, cumulative pain scores were significantly lower in the liposomal bupivacaine group than in the placebo group at 24, 72, and 96 hours after surgery (p<.05). It was noted that 43 of the 59 patients receiving liposomal bupivacaine (73%) and 20 of the 30 patients receiving placebo (67%) required a rescue opioid medication. The primary efficacy measure of the study was cumulative area under the curve of numeric rating scale pain severity scores through 48 hours post surgery. Least squares mean for area under the curve of numeric rating scale pain severity scores through 48 hours was signficantly lower for liposomal bupivacaine (120.8) than for placebo (183.3) (p=0.023). The median time to the first use of opioid rescue medication was 4.3 hours for the liposomal bupivacaine group versus 3.4 hours for the placebo group. The mean scores for the patient’s satisfaction with postsurgical pain control was nearly the same at each of the 24, 48, 72, and 96 hour time points of the study with no statistically significant differences.
Looking at all 162 patients in the above mentioned study, the incident of dysgeusia or the loss of the sense of taste was significantly higher in the liposomal bupivacaine group when compared with placebo group (p=0.012). The authors feel this is probably due to effects from the local anesthetics used in the study. The incident of headache was significantly lower in the liposomal bupivacaine group when compared with placebo group (p=0.047). According to an oral surgery patient brochure for Exparel, the most common side effects include nausea, vomiting, and constipation. Further according to the brochure Exparel is not recommended to be used in patients under 18 years of age or in pregnant women. It is also noted that other local anesthetics should not be injected immediately after injecting Exparel.
Due to the large number of protocol violations the sample size in the above mentioned study did not reach the a priori power calculation of 50 subjects per group for the efficacy analyses. Thus for this study the authors feel that additional investigation in prospective, randomized studies that incorporate clearly defined administration technique, and rigorous data collection protocol compliance are needed to adequately characterize the clinical profile of liposomal bupivacaine for wisdom teeth extractions.