Nerve Block for Reducing Pain After Wisdom Tooth Extraction

Overseen By Samuel YP Quek, DMD, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Rutgers, The State University of New Jersey

Must not be taking: Opioids, Acetaminophen, Ibuprofen

Disqualifiers: Age over 64, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

20 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have an allergy to dental local anesthetics or cannot tolerate common pain medications like opioids, acetaminophen, or ibuprofen, you may not be eligible to participate.

What data supports the effectiveness of the treatment Temporo-masseteric Nerve Block, Twin Block, TMNB for reducing pain after wisdom tooth extraction?

The twin block, which is part of the Temporo-masseteric Nerve Block, has been shown to be effective in managing masticatory myofascial pain, suggesting it may help reduce pain after wisdom tooth extraction. ^{1 2 3 4 5}

Is the twin block nerve block safe for humans?

The twin block nerve block has been used in studies for managing pain, such as masticatory myofascial pain, and no specific safety concerns have been highlighted in the available research. ^{1 4 6 7 8}

How does the nerve block treatment for wisdom tooth extraction differ from other treatments?

The nerve block treatment for wisdom tooth extraction is unique because it provides targeted pain relief by blocking specific nerves, reducing the need for opioids or NSAIDs, which can have side effects. This approach is similar to other nerve block techniques used in different dental and facial surgeries, offering effective pain management without the systemic effects of traditional pain medications. ^{1 2 3 5 9}

What is the purpose of this trial?

This is a pilot study evaluating the ability of the Temporo-masseteric Nerve Block local anesthetic injection (this was called the Twin Block earlier) to reduce pain experienced by individuals undergoing removal of lower third molar(s) under intravenous sedation. Study participants will be queried for pain experience and pain medications taken during the first post-operative week and will present for a follow-up visit on Day 8.

Research Team

Gayathri D Subramanian, PhD, DMD

Principal Investigator

Rutgers School of Dental Medicine

Eligibility Criteria

This trial is for adults aged 18-64 who need their lower wisdom teeth removed and can consent to the study. They must be healthy enough for sedation, not pregnant, have internet access with a smartphone, and able to take common pain meds like Tylenol or Advil.

Inclusion Criteria

My background or age does not limit my participation.

Not pregnant (as will not qualify to undergo procedure under intravenous sedation as part of routine standard-of-care)

I understand the details of the clinical trial and can give informed consent.

Exclusion Criteria

I have difficulty opening my mouth, with or without pain.

Pregnant

I am unable to understand and give consent for treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Procedure and Immediate Post-Procedure

Participants undergo lower wisdom molar extraction under intravenous sedation and receive the TMNB injection. Pain scores are recorded up to 4 hours post-procedure.

1 day

1 visit (in-person)

Post-operative Monitoring

Participants' pain experience and medication use are monitored daily for one week post-procedure. Adverse effects are also recorded.

1 week

Remote monitoring

Follow-up

Participants return for a post-operative evaluation to assess healing and any adverse effects.

1 day

1 visit (in-person)

Treatment Details

Interventions

• Temporo-masseteric Nerve Block

Trial Overview The study tests if a local anesthetic injection called Temporo-masseteric Nerve Block reduces pain after wisdom tooth removal under sedation. Participants will report their pain levels and medication use over the first week post-surgery.

Participant Groups

Group I: Temporo-masseteric Nerve Block (TMNB) Injection with Local Anesthetic Experimental Treatment 1 Intervention

Following lower third molar extraction under intravenous sedation, the patient will receive the TMNB local anesthetic nerve block using the standard dental local anesthetic, i.e,. 2% lidocaine with 1:100,000 epinephrine, on the side/s of lower wisdom molar extraction/s

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Findings from Research

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]

A study involving 100 patients demonstrated that the posterior superior alveolar nerve block (PSANB) alone is effective for pain control during maxillary third molar extractions, reducing the need for additional palatal injections.

The depth of anesthesia achieved with PSANB was sufficient for most cases, with effective coverage extending to the first molar, indicating that this method can simplify the procedure and improve patient comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posterior superior alveolar nerve block alone in the extraction of upper third molars: a prospective clinical study. Tummalapalli, S., M, RS., Inturi, NMR., et al.[2023]

Continuous mandibular nerve block using a catheter to deliver 0.25% bupivacaine provided excellent pain relief for two patients with mandible fractures, eliminating the need for additional analgesics post-surgery.

This method demonstrated no side effects, suggesting it could be a safe and effective alternative for managing pain in similar surgical procedures or conditions affecting the mandibular region.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous mandibular nerve block for pain relief. A report of two cases. Singh, B., Bhardwaj, V.[2022]

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]

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 twin block nerve block effectively targets both the masseteric and anterior deep temporal nerves, providing rapid and lasting relief for chronic masticatory myofascial pain, which is a common nonodontogenic pain condition.

This case series highlights the potential of the twin block as a promising alternative or complement to conventional treatments like physical therapy and medications for managing myofascial pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the twin block, a peripheral nerve block for the management of chronic masticatory myofascial pain: A case series. Kanti, V., Ananthan, S., Subramanian, G., et al.[2021]

A continuous bilateral mandibular nerve block (MNB) using a suprazygomatic approach effectively managed refractory trismus and pain in a patient with tetraplegia, providing analgesia for up to 72 hours.

This technique allowed for significant pain relief and improved mouth opening, enabling the introduction of kinesitherapy while minimizing the need for opioid analgesics, demonstrating its safety and efficacy in challenging clinical situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suprazygomatic Access for Continuous Bilateral Mandibular Nerve Block for Pain and Trismus Relief in the Tetraplegic Patient. Dziadzko, MA., Heritier, F.[2017]

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]

The mandibular nerve block is an effective technique for reducing peri-operative pain and improving visibility during mandibular osteotomy, making it a valuable alternative to general anesthesia for facial surgeries.

Using a neurostimulator to locate the mandibular nerve minimizes complications, such as failure or arterial puncture, and enhances patient comfort when combined with sedation techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Percutaneous mandibular nerve block using neuro-stimulation guiding through the sigmoid indentation in facial surgery]. Espitalier, F., Dubost, AF., Goga, D., et al.[2019]

References

1. United States 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. [2022]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Posterior superior alveolar nerve block alone in the extraction of upper third molars: a prospective clinical study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Continuous mandibular nerve block for pain relief. A report of two cases. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

The twin block injection: an adjunctive clinical aid for the management of acute arthrogenous temporomandibular joint dysfunction. [2021]

5. India pubmed.ncbi.nlm.nih.gov

Post operative pain relief through intermittent mandibular nerve block. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of the twin block, a peripheral nerve block for the management of chronic masticatory myofascial pain: A case series. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Suprazygomatic Access for Continuous Bilateral Mandibular Nerve Block for Pain and Trismus Relief in the Tetraplegic Patient. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

Ultrasound-guided maxillary nerve block: an anatomical study using the suprazygomatic approach. [2021]

9. France pubmed.ncbi.nlm.nih.gov

[Percutaneous mandibular nerve block using neuro-stimulation guiding through the sigmoid indentation in facial surgery]. [2019]