Temporo-masseteric Nerve Block for Postoperative Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of a Temporo-masseteric Nerve Block (TMNB) injection in reducing jaw pain after wisdom tooth removal. The study will assess whether this injection alleviates pain, improves mouth movement, and reduces the need for painkillers. Participants will receive either the actual TMNB injection or a placebo (a harmless substance resembling the real treatment) to compare results. Individuals scheduled for lower wisdom tooth extraction under sedation, who anticipate jaw pain the following day, may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used opioid pain medications in the past 3 months or are on long-term anti-inflammatory pain medication.
What prior data suggests that the Temporo-masseteric Nerve Block injection is safe for reducing jaw muscle pain?
A previous study showed that the Temporo-masseteric Nerve Block (TMNB) injection relieves pain and aids mouth movement. Research indicates that TMNB is generally well-tolerated, though some side effects can occur. These include pain at the injection site, swelling, or temporary facial nerve weakness. Such effects are usually mild and resolve on their own. Since this treatment uses a common dental anesthetic, like lidocaine, already approved for other uses, the safety profile is well understood. Overall, TMNB appears safe for most people, but it is important to consider these potential side effects.12345
Why are researchers excited about this trial's treatment?
Researchers are excited about the Temporo-masseteric Nerve Block (TMNB) for postoperative pain management because it offers a targeted approach to pain relief right at the source, unlike standard options such as oral pain medications. Most pain relief after wisdom tooth removal involves systemic drugs like ibuprofen and acetaminophen, which circulate throughout the body and can have side effects. TMNB is delivered directly to the nerves affecting the jaw muscles, potentially providing faster and more localized pain relief. Additionally, the use of dental local anesthetic like 2% lidocaine with epinephrine in TMNB could offer a more effective pain block compared to traditional systemic painkillers.
What evidence suggests that the Temporo-masseteric Nerve Block injection is effective for reducing jaw muscle pain?
In this trial, participants will receive different treatments to manage postoperative pain after wisdom tooth removal. Research has shown that Temporo-masseteric Nerve Block (TMNB) injections can greatly reduce jaw pain. In one study, patients reported a 70% drop in pain levels after receiving a TMNB injection. This treatment also alleviates trismus, a condition where opening the mouth is difficult. TMNB works by blocking pain signals in the jaw, providing relief after wisdom tooth removal. Previous studies suggest that this treatment is generally safe and effective. Participants in this trial may receive a TMNB with either a dental local anesthetic or a placebo, while others will follow a standard pain management regimen with ibuprofen and acetaminophen.14678
Are You a Good Fit for This Trial?
This trial is for adults over 18 who need at least one lower wisdom tooth removed and are in good health with no cognitive disabilities, jaw pain, reduced motion in the jaw, or past trauma/surgery in that area. Participants must have a smart device with internet to record their experience.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo lower third molar removal under sedation and are assessed for jaw muscle pain. Those with significant pain receive either TMNB injection or placebo.
Follow-up
Participants are monitored for pain reduction and mouth opening ability through daily remote surveys and an in-person assessment on Day 8.
Qualitative Interview
Participants randomized to TMNB/placebo may participate in a qualitative interview regarding their experience.
What Are the Treatments Tested in This Trial?
Interventions
- Temporo-masseteric Nerve Block Injection
Trial Overview
The study tests if a Temporo-masseteric Nerve Block (TMNB) injection can reduce jaw muscle pain after wisdom tooth removal compared to placebo. It's a triple-blind phase II trial where patients' experiences are recorded daily until an end-of-study evaluation on Day 8.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Participants whose jaw muscle pain to palpation is 5 or higher on on Numerical Pain Rating Scale (NRS) the day after lower wisdom molar removal under sedation will be randomized to either placebo (sterile saline) or to the dental local anesthetic. The dental local anesthetic (2% lidocaine with 1:100,000 epinephrine) will be delivered as the Temporo-masseteric Nerve Block injection. The randomization is blind to the participant and to the investigator administering the injection. The participants will be recommended post-operative pain management with a fixed interval dosing of ibuprofen 600 mg along with acetaminophen 325 mg taken every 6 hours for the first 72 hours post-procedure, after which they are encouraged to take prn dosing.
Participants whose jaw muscle pain to palpation is \<5 on Numerical Pain Rating Scale (NRS) the day after lower wisdom molar removal under sedation will be recommended post-operative pain management with a fixed interval dosing of ibuprofen 600 mg along with acetaminophen 325 mg taken every 6 hours for the first 72 hours post-procedure, after which they are encouraged to take prn dosing.
Participants whose jaw muscle pain to palpation is 5 or higher on on Numerical Pain Rating Scale (NRS) the day after lower wisdom molar removal under sedation will be randomized to either placebo (sterile saline) or to the dental local anesthetic. The placebo will be delivered as the Temporo-masseteric Nerve Block injection. The randomization is blind to the participant and to the investigator administering the injection. The participants will be recommended post-operative pain management with a fixed interval dosing of ibuprofen 600 mg along with acetaminophen 325 mg taken every 6 hours for the first 72 hours post-procedure, after which they are encouraged to take prn dosing.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rutgers, The State University of New Jersey
Lead Sponsor
National Institute of Dental and Craniofacial Research (NIDCR)
Collaborator
Citations
RePORT RePORTER
Outcomes; Clinical Studies; News and More; History; Similar Projects. Temporo-masseteric Nerve Block in post-wisdom tooth extraction pain - a randomized study.
The Temporo-Masseteric Nerve Block (TMNB) for ...
The pain was accompanied by trismus. Both the pain and limitation in mouth opening were relieved by the TMNB injection, and symptom alleviation ...
Nerve Block for Reducing Pain After Wisdom Tooth Extraction
A study involving 100 patients demonstrated that the posterior superior alveolar nerve block (PSANB) alone is effective for pain control during maxillary third ...
Safety, efficacy, and mechanism of action of the temporo- ...
52 instances had available baseline and post-TMNB Numerical Pain Rating Scores (NRS) scores, the TMNB injection reduced baseline NRS scores by 70%; pain ...
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researchgate.net
researchgate.net/publication/387963347_Safety_efficacy_and_mechanism_of_action_of_the_temporo-masseteric_nerve_block(PDF) Safety, efficacy, and mechanism of action of the ...
The objective of the study was to assess the utility and safety of Temporo-masseteric Nerve Block (TMNB), and to explore the mechanism for its ...
Safety, efficacy, and mechanism of action of the temporo- ...
The objective of the study was to assess the utility and safety of Temporo-masseteric Nerve Block (TMNB), and to explore the mechanism for its apparent ...
Oral Pain Medications only and Temporo-masseteric Nerve Block ...
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 ...
Nerve blocks and interventional procedures in the ...
Although a relatively safe and less invasive procedure, pain, edema, transient facial nerve paralysis due to local anesthetic, injury to the ...
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