48 Participants Needed

Twin Block Anesthesia for Acute Pain

GS
BK
Overseen ByBrahmleen Kaur, DMD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Rutgers, The State University of New Jersey
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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 data supports the effectiveness of the Twin Block Anesthesia treatment for acute pain?

The Twin Block Injection has been shown to be effective in managing masticatory myofascial pain, which suggests it may help with other types of acute pain. Additionally, regional anesthesia, like nerve blocks used in dental procedures, is becoming a standard for pain management, indicating its potential effectiveness.12345

Is Twin Block Anesthesia generally safe for humans?

Local anesthetic nerve blocks, like those used in Twin Block Anesthesia, are generally safe with few complications, though there can be risks like nerve damage or unusual numbness. These risks can be minimized with careful injection techniques.678910

How is the Twin Block local anesthetic nerve block treatment different from other treatments for acute pain?

The Twin Block local anesthetic nerve block is unique because it targets specific branches of the trigeminal nerve, which may provide more effective pain relief for conditions like masticatory myofascial pain compared to other nerve blocks. It is a novel approach that has shown promise in managing pain associated with the temporomandibular joint (TMJ) and differs from standard dental anesthetic techniques by its specific nerve targeting.211121314

What is the purpose of this trial?

Each year, over 3.5 million, mostly, healthy young adults, have their third molar teeth ('wisdom teeth') removed under sedation and are often given opioid prescriptions for managing their pain. Wisdom molar removal is one of the most common reasons for opioid prescriptions to be given to adolescents. There is a national thrust to reduce both the dose and the duration of such opioid prescriptions because even short-term opioid exposures increase risk for narcotic addiction and misuse. Non-opioid options to manage pain will still allow for sufficient pain control without risking addiction, and hence, a fundamental component of our response to combat the current national opioid crisis.The investigators are going to study a promising option- the Twin Block dental anesthetic injection. The Twin block involves injecting the standard dental numbing medication in a way that 'numbs' the 'jaw-clencher' muscles on the side of the face. The investigators found that the Twin block relieved jaw pain stemming from these muscles, in a quick and sustained manner, even in patients whose pain following wisdom tooth removal primarily came from 'taut' and tender jaw-clencher muscles. However, what is not known is- how often do patients who have their wisdom teeth removed under sedation, end up in significant pain from taut and tender jaw-clencher muscles? Will using the twin block effectively reduce pain in such patients? In this pilot study, the investigators will examine wisdom molar extraction patients one day after their procedure. Those with significant pain (pain rated ≥ 5 on a 0-10 scale) in their jaw-clencher muscles, will get either the Twin block injection or a placebo. The investigators will track both 1) pain before and after the injection, and 2) pain medication usage over a 7-day period to see if both pain and opioid dosage come down with the Twin block. This study can support a simple, safe and inexpensive means to reduce pain after a common procedure.

Research Team

GS

Gayathri Subramanian, PhD, DMD

Principal Investigator

Rutgers School of Dental Medicine, Newark NJ

Eligibility Criteria

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
See 4 more

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.
See 1 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: Twin Block with Local AnestheticActive Control1 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 salinePlacebo Group1 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

Find a Clinic Near You

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+

Findings from Research

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

References

Regional anesthesia and analgesia for oral and dental procedures. [2005]
The twin block injection: an adjunctive clinical aid for the management of acute arthrogenous temporomandibular joint dysfunction. [2021]
Anesthetic Efficacy of Supine and Upright Positions for the Inferior Alveolar Nerve Block: A Prospective, Randomized Study. [2018]
Failure of inferior alveolar nerve block in endodontics. [2022]
Is the mandibular nerve block passé? [2019]
Ultrasound-guided maxillary nerve block: an anatomical study using the suprazygomatic approach. [2021]
Advantages of anterior inferior alveolar nerve block with felypressin-propitocaine over conventional epinephrine-lidocaine: an efficacy and safety study. [2020]
Regional Anesthesia for Orthobiologic Procedures. [2022]
An unusual complication of an inferior dental nerve block: a case report. [2009]
Post operative pain relief through intermittent mandibular nerve block. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Administering dental nerve blocks. [2007]
12.Korea (South)pubmed.ncbi.nlm.nih.gov
Making inferior alveolar nerve block more comfortable via computer-controlled local anesthetic delivery: A prospective clinical study. [2022]
13.United Statespubmed.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]
Comparison of success rate and onset time of two different anesthesia techniques. [2019]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security