Twin Block Anesthesia for Acute Pain

Overseen By Brahmleen Kaur, DMD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Rutgers, The State University of New Jersey

Must not be taking: Opioids, Anti-inflammatories

Disqualifiers: Pregnancy, Infection, Allergies, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to manage pain after wisdom tooth removal without opioids. Researchers are testing the "Twin Block" injection, which numbs the jaw muscles that often cause pain after the procedure. Participants will receive either this anesthetic or a placebo to determine its effectiveness in reducing pain and the need for opioids. The trial seeks healthy individuals experiencing significant jaw pain after the removal of at least one impacted wisdom tooth. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to innovative pain management solutions.

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 have used opioid pain medications in the past or are on long-term anti-inflammatory pain medication.

What prior data suggests that the Twin Block dental anesthetic injection is safe for managing acute pain?

Research shows that local anesthetic nerve blocks, such as the Twin Block, are generally safe and well-tolerated. Previous studies have reported few complications with these anesthetics. Although there is a small risk of nerve damage, it remains rare. The Twin Block uses a common dental anesthetic, known to be safe for most people, and most individuals do not experience serious side effects. This makes the Twin Block a promising option for managing pain after wisdom teeth removal, potentially reducing the need for opioids without significant risk. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the Twin Block Anesthesia because it could offer a new way to manage acute pain following dental procedures, like wisdom tooth extractions. Most standard treatments rely on oral pain medications, which can take time to work and may have systemic side effects. Unlike these options, the Twin Block approach directly targets the nerve using a local anesthetic, 2% lidocaine with 1:100,000 epinephrine, providing potentially faster and more localized pain relief. This method could mean quicker pain management with fewer side effects, making recovery from dental surgery more comfortable.

What evidence suggests that the Twin Block dental anesthetic injection is effective for reducing pain after wisdom tooth removal?

Research has shown that the Twin Block injection effectively reduces pain in the jaw muscles. In earlier studies, this method provided quick and long-lasting relief for pain in the jaw and nearby muscles. Some reports indicate it also alleviates pain, swelling, and muscle stiffness after wisdom tooth removal. In this trial, participants will be randomized to receive either the Twin Block with a local anesthetic or the Twin Block with sterile normal saline. The Twin Block numbs the nerves controlling the jaw muscles, reducing pain in these areas. This suggests that using the Twin Block could decrease the need for opioids after dental surgery, offering relief without the risk of addiction. ^{1 4 6 7 8}

Who Is on the Research Team?

Gayathri Subramanian, PhD, DMD

Principal Investigator

Rutgers School of Dental Medicine, Newark NJ

Are You a Good Fit for This Trial?

This trial is for healthy adults over 18 needing at least one lower wisdom tooth removed, who can use a smart device with internet. They shouldn't have jaw pain or limited motion history, be pregnant, prisoners, children, or intellectually disabled. Allergies to local anesthetics or common pain relievers like Tylenol and Advil are disqualifiers.

Inclusion Criteria

I have not had jaw pain, limited movement, trauma, or surgery recently.

I need at least one lower wisdom tooth removed and it's partially or fully stuck.

Patients with no cognitive/intellectual disability

Exclusion Criteria

I am allergic to or cannot tolerate dental anesthetics, opioids, Tylenol, or Advil.

I have an infection in my wisdom teeth that will be removed on the day of my procedure.

I have used opioid painkillers or have been on long-term anti-inflammatory pain medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants undergo third molar extraction under intravenous sedation and receive either the Twin block or placebo injection based on randomization

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain levels and opioid consumption over a 7-day period

1 week

Daily contact for pain and medication tracking

What Are the Treatments Tested in This Trial?

Interventions

• Twin Block local anesthetic nerve block using standard dental anesthetic
• Twin block with placebo

Trial Overview

The study tests the Twin Block dental anesthetic injection versus a placebo in managing post-wisdom tooth removal pain. It aims to see if this technique reduces both the intensity of jaw-clencher muscle pain and the need for opioid medication after surgery.

How Is the Trial Designed?

Group I: Twin Block with Local Anesthetic Active Control 1 Intervention

Following lower third molar extraction under intravenous sedation, the patient randomized to this arm with receive the Twin block local anesthetic nerve block using the standard dental local anesthetic, i.e,. 2% lidocaine with 1:100,000 epinephrine, on the day after extraction, if the patient has pain greater than or equal to 5 on 10 in their jaw-closer muscles (Numerical Pain rating scale).

Group II: Twin Block with sterile normal saline Placebo Group 1 Intervention

Following lower third molar extraction under intravenous sedation, the patient randomized to this arm with receive the Twin block using sterile normal saline, on the day after extraction, if the patient has pain greater than or equal to 5 on 10 in their jaw-closer muscles (Numerical Pain rating scale).

Twin Block local anesthetic nerve block using standard dental anesthetic is already approved in United States, European Union for the following indications:

Approved in United States as Twin Block local anesthetic nerve block for:

• Pain management for third molar extractions

Approved in European Union as Twin Block local anesthetic nerve block for:

• Pain management for dental procedures

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

New Jersey Health Foundation

Collaborator

New Jersey Health Foundation

Collaborator

Trials

3

Recruited

220+

Published Research Related to This Trial

The twin block injection is effective in reducing pain from both the temporomandibular joint (TMJ) and associated muscle pain, as demonstrated in a case study of a 19-year-old man with acute anterior disc displacement and myalgia.

After receiving the twin block injection, the patient experienced significant pain relief in the TMJ and surrounding muscles, indicating its potential as a treatment for temporomandibular disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The twin block injection: an adjunctive clinical aid for the management of acute arthrogenous temporomandibular joint dysfunction. Ananthan, S., Subramanian, G., Patel, T., et al.[2021]

Dental nerve blocks are an effective and cost-efficient method for managing pain during oral procedures, offering quick relief and complementing other forms of anesthesia.

The article provides guidance on how to properly administer these nerve blocks, along with important indications and precautions to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Administering dental nerve blocks. Reuss-Lamky, H.[2007]

In a study of 110 asymptomatic subjects, the position of the patient (upright vs. supine) during inferior alveolar nerve block (IANB) administration did not significantly affect the success of pulpal anesthesia in molars and anterior teeth.

The supine position did show improved success rates for pulpal anesthesia in premolars, but overall, neither position provided complete pulpal anesthesia, indicating that other factors may influence the effectiveness of IANB.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anesthetic Efficacy of Supine and Upright Positions for the Inferior Alveolar Nerve Block: A Prospective, Randomized Study. Crowley, C., Drum, M., Reader, A., et al.[2018]

The traditional inferior alveolar nerve block (IANB) has a high failure rate, particularly in the mandible, with an 81% failure rate noted in lateral incisors, making it a less reliable method for dental anesthesia.

Factors contributing to the IANB's failure include the thickness of the cortical bone and soft tissue at the injection site, difficulty in locating the nerve, and potential accessory innervation, highlighting the need for alternative techniques to improve pain control in dental procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is the mandibular nerve block passé? Malamed, SF.[2019]

In a study of 64 adult patients receiving inferior alveolar nerve blocks, those treated with computer-controlled local anesthetic delivery (CCLAD) reported significantly less pain during the injection compared to those receiving the conventional syringe method, with a P value of 0.003.

While CCLAD reduced pain perception, patient comfort levels were similar between both techniques, indicating that while CCLAD is more effective at minimizing pain, it does not necessarily enhance overall comfort during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Making inferior alveolar nerve block more comfortable via computer-controlled local anesthetic delivery: A prospective clinical study. Gajendragadkar, K., Bhate, K., Jagtap, B., et al.[2022]

The twin block nerve block technique is effective for the long-term management of masticatory myofascial pain, showing similar pain reduction to trigger point injections over a 6-month period in a study of 40 patients.

Both treatment methods resulted in significant pain reduction from baseline (around 6.5) to follow-up (around 1.85), but there were no statistically significant differences in pain intensity between the two groups, indicating that the twin block is a viable alternative to trigger point injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of the twin block compared with trigger point injections in patients with masticatory myofascial pain: a pilot study. Ananthan, S., Kanti, V., Zagury, JG., et al.[2022]

In a study of 136 patients undergoing mandibular molar extractions, the Gow-Gates (GG) technique showed a higher clinical success rate (92.02%) compared to the standard inferior alveolar nerve block (IANB) technique (80.82%), although this difference was not statistically significant (P=0.123).

Both techniques had similar onset times for lip and buccal soft tissue numbness, with no significant differences found (P values >0.05), indicating that both methods are effective for pain control in dental procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of success rate and onset time of two different anesthesia techniques. Haghighat, A., Jafari, Z., Hasheminia, D., et al.[2019]

A study using cadaveric specimens found that a 1 mL injection for a maxillary nerve block effectively covers the nerve, suggesting it may be a safer option compared to a 5 mL injection, which often leads to drug spread outside the targeted area.

The research quantified the optimal angles and depths for needle insertion, providing valuable insights that could improve the reliability and efficacy of maxillary nerve blocks in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided maxillary nerve block: an anatomical study using the suprazygomatic approach. Echaniz, G., Chan, V., Maynes, JT., et al.[2021]

Peripheral nerve blocks (PNB) can effectively reduce procedural pain and avoid harmful effects of local anesthetics on target tissues, enhancing patient comfort during procedures.

The risks associated with PNBs, such as local nerve damage and systemic toxicity, can be minimized through careful injection techniques and a thorough understanding of the procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regional Anesthesia for Orthobiologic Procedures. Khadavi, M., Rehor, D., Roney, A., et al.[2022]

An unusual complication occurred during an inferior dental nerve block, where the patient experienced profound numbness and skin pallor in the area supplied by the infra-orbital nerve.

This case highlights the importance of understanding the anatomical pathways and potential risks associated with local anaesthetic administration in dental procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An unusual complication of an inferior dental nerve block: a case report. Paul, R., Anand, R., Wray, P., et al.[2009]

Regional anesthesia and analgesia are increasingly recognized as standard care practices, providing benefits for clients, patients, and practitioners alike.

Incorporating local anesthetic blocks, along with other pain management strategies like opioids and nonsteroidal anti-inflammatory drugs, is essential for effective treatment in dental and oral surgery procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regional anesthesia and analgesia for oral and dental procedures. Rochette, J.[2005]

The anterior technique (AT) for inferior alveolar nerve block provides comparable success rates to the conventional technique (CT), with 60-65% effectiveness in numbing the mandible, indicating it is a viable alternative.

The AT offers a significantly longer duration of anesthesia (approximately 40 minutes longer) and causes less injection pain compared to the CT, making it a safer and more comfortable option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advantages of anterior inferior alveolar nerve block with felypressin-propitocaine over conventional epinephrine-lidocaine: an efficacy and safety study. Shinzaki, H., Sunada, K.[2020]

Mandibular nerve block using 0.25% bupivacaine provided effective pain relief for a patient undergoing surgery for a mandibular fracture, with Visual Analog Scale (VAS) scores remaining below 4 throughout the observation period.

The procedure demonstrated a favorable safety profile, with the only side effect being temporary numbness of the lower jaw, which resolved after stopping the local anesthetic administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post operative pain relief through intermittent mandibular nerve block. Sawhney, C., Agrawal, P., Soni, KD.[2021]

The standard inferior alveolar nerve block (IANB) is commonly used for pain relief in dental procedures, but it fails to provide adequate analgesia in 30% to 45% of cases, particularly in patients with inflamed mandibular molars.

The reasons for the failure of IANB are not completely understood, but the paper discusses potential anatomical and physiological factors that may contribute to this issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Failure of inferior alveolar nerve block in endodontics. Potocnik, I., Bajrović, F.[2022]

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