Temporo-masseteric Nerve Block in post-wisdom tooth extraction pain—protocol for a placebo-controlled randomized double-blind phase II pilot

Annually, over 3.5 million predominantly young and healthy individuals undergo out-patient wisdom tooth extractions. Often these individuals are prescribed postoperative opioid pills, a practice that introduces opioids to opioid-naïve patients and poses a risk of future repeat use. We have observed the Temporo-masseteric Nerve Block (TMNB), a local anesthetic regional nerve block injection targeting jaw-closer muscles, to provide prompt, and sustained pain relief and ease mouth opening in patients who presented with severe pain the day following extractions. We hypothesize that at least a portion of the post-surgical pain in patients who have undergone wisdom molar removal under sedation stems from jaw muscle spasm, and that administering the TMNB on the day after surgery, will provide prompt, and sustained pain relief and ease mouth opening. The proposed study design is a double-blind, placebo-controlled randomized phase II trial (ClinicalTrials.gov NCT07094542; original release 07/30/2025) to: Aim 1: Evaluate the effectiveness and potential efficacy of the TMNB injection to alleviate pain and jaw function impairment following lower third molar extraction under sedation through a randomized blinded pilot clinical trial. Aim 2: Define facilitators, barriers, and acceptability of the TMNB as a modulator of post-surgical recovery. Eighty participants undergoing lower third molar removal under sedation will be enrolled. Those who develop significant jaw muscle pain on the following day will be randomized to receive either the TMNB injection or a placebo. The jaw muscles’ pain to palpation before and 15 min after the TMNB injection that day will be assessed. Daily ecological momentary assessments (EMAs) will be collected reflecting elements of patient experience for all participants for a week, after which participants return for an end-of-study evaluation. Up to 40 participants who are randomized to receive TMNB/placebo will be recruited to participate in a qualitative interview regarding their experience. Targeted use of the TMNB after third molar extractions can address a largely understudied aspect of post-surgical morbidity. It is inexpensive, safe, and easy and can be seamlessly incorporated, potentially reducing the reliance on opioids to reduce recalcitrant pain. Timely alleviation of acute jaw muscle spasm pain will greatly enhance the quality of post-surgical recovery.