Temporo-masseteric Nerve Block in Post-wisdom Tooth Extraction Pain- a Randomized Study
Rutgers, The State University of New Jersey
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.
Description
The study is designed as a parallel, blinded, randomized phase II pilot study to assess the ability of the Temporo-masseteric Nerve Block (TMNB) injection to reduce post-operative pain in patients who undergo removal of lower third molar/s under sedation. It is not known how often and in whom jaw muscle pain significantly contributes to post-operative pain, limitation in mouth opening, and function. and develop significant jaw muscle pain. Hence the study is designed to assess the development of such jaw muscle pain before testing the placebo-controlled TMNB intervention. Accordingly, 80 subje…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: All patients recommended extraction/s of at least 1 lower wisdom (third) molar that is partially/fully 'impacted' under intravenous sedation, are eligible to participate in this study so long as they * are 18 years or older, * are healthy, * have no cognitive/intellectual disability, * have no past/recent pain or reduced range of motion in their jaw joint/ muscle complex, no trauma or surgery in their jaw region. * have an electronic device such as a smart phone or a tablet/ computer with internet connection. * are willing to participate in the study and not be excluded b…
Interventions
- DrugTemporo-masseteric Nerve Block Injection
The TMNB injection/placebo will be administered by the Principal Investigator. The injection will only be delivered on Day 2 on the side/s of significant jaw muscle pain. Following disinfection of skin overlying the suprazygomatic injection site, a single carpule of 1.8 ml 2% lidocaine with 1:100,000 epinephrine will be delivered using a 25- or 27- gauge 30 mm needle). The injection site will be approximately a centimeter above the zygomatic arch, and a centimeter behind the palpable posterior border of the frontal process of the zygomatic bone. The needle will be directed at a 45-degree downward angle, directed medially along the coronal plane. At the depth of insertion of the needle, the local anesthetic/placebo will be delivered.
- DrugOral Pain Medications only
For participants with jaw muscle pain to palpation \<5 NRS score, no additional injection will be given. The participant will take the recommended pain medications as described.
Location
- Rutgers School of Dental MedicineNewark, New Jersey