Jaw Muscle Pain Post Wisdom Molar Surgery
Summary
The proposed design is a triple-blind, placebo-controlled randomized prospective phase II trial to assess the feasibility of employing the Temporo-masseteric Nerve Block (TMNB) injection to decrease jaw muscle pain, overall pain, improve mouth opening and minimize pain medication consumption. 80 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. Daily ecological momentary assessments (EMAs) will be collected reflecting elements of patient experience for all participants. On Day 8, participants return for an end-of-study evaluation and return their unused pain medications. Up to 40 participants who are randomized to receive TMNB/placebo will be recruited to participate in a qualitative interview regarding their experience.
Timeline
- Start
- 2026-09
- Primary completion
- 2029-11
- Completion
- 2030-05
Publications
- Background Subramanian G, Quek SYP. The Temporo-Masseteric Nerve Block (TMNB) for Alleviating Acute Postextraction Masticatory Myalgia: A Case Series. Anesth Prog. 2025 Mar 12;72(1):37-42. doi: 10.2344/24-0001.
- Background Subramanian G, Makhija D, Ananthan S, Stitik TP, Quek SYP. Safety, efficacy, and mechanism of action of the temporo-masseteric nerve block. J Oral Facial Pain Headache. 2024 Jun;38(2):68-73. doi: 10.22514/jofph.2024.014. Epub 2024 Jun 12.
- Background Quek SYP, Gomes-Zagury J, Subramanian G. Twin Block in Myogenous Orofacial Pain: Applied Anatomy, Technique Update, and Safety. Anesth Prog. 2020 Jun 1;67(2):103-106. doi: 10.2344/anpr-67-01-03.
- Background Kanti V, Ananthan S, Subramanian G, Quek SYP. Efficacy of the twin block, a peripheral nerve block for the management of chronic masticatory myofascial pain: A case series. Quintessence Int. 2017 Oct 6:725-729. doi: 10.3290/j.qi.a39094. Online ahead of print.
- Background Ananthan S, Kanti V, Zagury JG, Quek SYP, Benoliel R. The effect of the twin block compared with trigger point injections in patients with masticatory myofascial pain: a pilot study. Oral Surg Oral Med Oral Pathol Oral Radiol. 2020 Mar;129(3):222-228. doi: 10.1016/j.oooo.2019.09.014. Epub 2019 Oct 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lidocaine | Other / unclassified | 1.8 ml | Other |
| Subject | Lidocaine | Other / unclassified | 2 % | Other |
| Comparator | Acetaminophen | Small molecule | 325 mg | Oral |
| Background | Epinephrine | Other / unclassified | — | Other |
| Comparator | Ibuprofen | Small molecule | 600 mg | Oral |