Temporo-masseteric Nerve Block in post-wisdom tooth extraction pain - a randomized study - PROJECT SUMMARY/ABSTRACT This integrated research and training plan will prepare Dr. Subramanian, an attending in a dental school- and hospital-based residency program, to become an independent NIH-funded dentist-scientist with expertise in non-opioid pain-mitigative strategies during post-surgical recovery, following prevalent surgeries such as impacted third molar removal. Annually, over 3.5 million predominantly young and healthy individuals undergo out-patient wisdom tooth extractions. A vast majority of these individuals are prescribed postoperative opioid pills, a practice that often introduces opioids to opioid-naïve patients and poses a risk of future repeat use. Pain and limitation to mouth opening remain the two most serious consequences during the week of post-surgical recovery. This innovative proposal explores the ability of a novel local anesthetic injection (the temporo-masseteric nerve block or ‘TMNB’) developed by Dr. Subramanian and team, that ‘numbs’ the jaw closer muscles to reduce post-surgical pain and ease mouth opening during the post-surgical week. The TMNB has shown early promise in providing sustained pain and jaw muscle spasm relief post-dental surgical procedures and in alleviating chronic jaw muscle pain. Using the TMNB is expected to complement pain relief from non-opioid analgesics, and, secondarily, reduce resorting to opioids, mitigating the prescription opioid crisis. Under the guidance of a strong team of NIH-funded clinical trialists, Dr. Subramanian will accomplish two key training goals that integrate with the specific aims of her research plan 1) Gain experience in designing, executing, and analyzing clinical trials, and 2) Learn qualitative research methods and analysis. Dr. Subramanian’s training activities will be complemented by an innovative research plan that will provide experiential and practical exposure. She will test the feasibility and potential efficacy of the TMNB in reducing post-surgical pain and jaw functional limitation compared to conventional treatment in a triple blind, placebo- controlled pilot phase II trial. Per this study design, 80 subjects undergoing impacted lower third molar extractions under sedation will be randomized to receive the TMNB injection/ saline if they develop significant jaw muscle pain after surgery. In addition to chairside outcome assessment, patient-reported outcomes will be collected remotely on a daily basis for a week. All participants will receive identical guidance for pain medications usage. At the end of study, Dr. Subramanian will conduct qualitative interviews with subjects who were previously randomized to TMNB/placebo to understand potential patient-centered strategies to describe the TMNB experience, understand post-operative recovery and guide oral analgesic use during the postoperative period. This research will be critical for designing rigorous future clinical trials to validate the TMNB intervention. This innovative K23 Mentored Patient Oriented Career Development Award responds to NIH high priority HEAL topics including the exploration of non-opioid strategies to improve pain control and ultimately develop guidelines to improve pain management and reduce reliance on opioids.
