A Phase 2 interventional study of Temporo-masseteric Nerve Block Injection and Oral Pain Medications only in Post Operative Pain, Impacted Third Molar Tooth and Muscle Pain, sponsored by Rutgers, The State University of New Jersey. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by Rutgers, The State University of New Jersey · Phase 2, Interventional, and Treatment
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.
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 subjects who undergo lower third molar extractions under intravenous sedation are randomized to receive either the TMNB (standard-of-care local anesthetic, 1.8 ml 2% lidocaine with 1:100,000 epinephrine), or a placebo (TMNB injection technique, but with 1.8 ml of sterile isotonic saline instead) the day following their extraction/s should they report significant pain (≥5 on a scale of pain rating from 0 to 10) when the jaw muscles are 'palpated' or examined with firm finger pressure. The assessment will be repeated 15 minutes after the injection. On the other hand, those who report less pain (\<5) to jaw muscle palpation will not receive any injection. The participant, TMNB administrator and the evaluator will be blinded from randomization assignment. All participants will fill out daily remote surveys administered through REDCap® that will assess peak NRS pain score for the previous 24 hours, limitation in mouth opening and function, oral health related quality of life, pain medication consumption, and adverse effects from pain medications. Patient responses will be collected remotely and will include patient-uploaded cropped selfies of spontaneous mouth-opening with a disposable millimeter ruler (Orastretch®) propped between the upper and lower incisors.
It is anticipated that approximately 50% of patients will develop significant jaw muscle pain following the procedure. Hence, of the 80 participants, 40 are anticipated to be eligible for randomization, with 20 participants receiving the placebo or the TMNB injection, respectively.
Participants will return for an in-person assessment on Day 8, will return unused medications and will get an opportunity to participate in a qualitative interview to interrogate their experience receiving the injection (those randomized to TMNB/placebo), and their recovery experience. The duration of participation is a week from undergoing the procedure.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 80 is close to the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Rutgers, The State University of New Jersey is the lead sponsor of 506 studies on the registry; 131 are open to participants now.
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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
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
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.
Drug: Oral Pain Medications only
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.
Drug: Temporo-masseteric Nerve Block Injection
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.
Drug: Temporo-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.
Also known as: TMNB, Twin Block
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.
Jaw Muscle Pain Reduction on palpation post-TMNB injections
To assess the effect of TMNB injection on the Numerical Pain Rating Scale (NRS) corresponding to Jaw muscle pain-to-palpation reported by the participant, when assessed 15 minutes post-injection.
Time frame: Day 2 15 minutes post TMNB injection
Sustained Benefit from TMNB Injection- pain reduction
Comparison of peak NRS pain score, the highest pain level as perceived by the participant collected for the preceding 24 hours.
Time frame: 24-, 48-, 72-, and 96- hours post-injection
Sustained Benefit from TMNB Injection- mouth opening
Comparison of spontaneous maximum mouth opening, measured in millimeters
Time frame: 24-, 48-, 72-, and 96- hours post-injection
Opioid consumption to 'rescue' pain poorly responsive to recommended pain medication regimen
Compare need for rescue opioid medication among the three groups
Time frame: 8 Days
Plan to share: Yes — Final results will be posted no later than 12 months after the trial's primary completion date and will include participant flow, demographic and baseline characteristics, outcomes and statistical analyses, adverse events, the protocol, statistical analysis plan and administrative information. The PI will share the individual non-identified subject data no later than acceptance for the publication's main findings from the final data analysis or 18 months after completion of the study, whichever is earlier. Data to be posted will include the study protocol, reference to study publication of primary outcome variable, the data set in both SAS and ASCII formats, data dictionary and study specific de-identification notes.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Deidentified data will be released within 12 months of primary completion date.
Access criteria: Upon written request to the PI, survey instruments or other materials developed for use during the clinical trial will be made electronically available to other researchers.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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