Twin Block Anesthesia for Acute Pain
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Rutgers, The State University of New Jersey
Must not be taking: Opioids, Anti-inflammatories
Disqualifiers: Pregnancy, Infection, Allergies, others
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
678910How 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.
211121314Eligibility 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
+4 more
Exclusion Criteria
I am not a prisoner, child, pregnant, or have an intellectual disability.
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.
+2 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Rutgers School of Dental MedicineNewark, NJ
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Who Is Running the Clinical Trial?
Rutgers, The State University of New JerseyLead Sponsor
New Jersey Health FoundationCollaborator
References
Regional anesthesia and analgesia for oral and dental procedures. [2005]Regional anesthesia and analgesia benefit the client, the patient, and the practitioner, and their use is becoming the standard for care. Familiarity with the processes involved in the generation of pain aids in understanding the benefits of preemptive and multimodal analgesia. Local anesthetic blocks should be a key component of a treatment plan, along with opioids, nonsteroidal anti-inflammatory drugs, N-methyl-D-aspartate receptor antagonists, and other therapies. Nerve blocks commonly used for dentistry and oral surgery include the infraorbital, maxillary, mental,and mandibular blocks.
The twin block injection: an adjunctive clinical aid for the management of acute arthrogenous temporomandibular joint dysfunction. [2021]The twin block Injection is a novel nerve block that has been shown previously to be efficacious in the management of masticatory myofascial pain. Little is known about its effectiveness for reducing pain from the temporomandibular joint (TMJ).
Anesthetic Efficacy of Supine and Upright Positions for the Inferior Alveolar Nerve Block: A Prospective, Randomized Study. [2018]It has been recommended to place patients in an upright position after administration of an inferior alveolar nerve block (IANB), theoretically allowing the anesthetic to diffuse in an inferior direction and resulting in better pulpal anesthesia. The purpose of this study was to compare an upright versus a supine position on the success of pulpal anesthesia when an IANB was administered in asymptomatic teeth.
Failure of inferior alveolar nerve block in endodontics. [2022]Analgesia is essential for successful completion of modern dental procedures. Standard inferior alveolar nerve block (IANB) is the primary method used to achieve mandibular analgesia. Difficulty experienced in obtaining satisfactory analgesia after IANB, especially of an acutely inflamed mandibular molar, remains a common clinical problem. Even when a proper technique is employed, clinical studies show that IANB fails in approximately 30% to 45% of cases. The reasons for failure are not fully understood. Anatomical considerations and abnormal physiological responses in the presence of inflammation as explanations for IANB failure are discussed in this paper.
Is the mandibular nerve block passé? [2019]Providing effective pain control is a critical part of dental treatment, yet achieving consistently reliable anesthesia in the mandible has proved elusive. The traditional inferior alveolar nerve block (IANB) has a high failure rate; for example, the failure rate in lateral incisors is 81 percent. As a consequence, new approaches and techniques have been developed. The purpose of this supplement to The Journal of the American Dental Association is to determine whether the mandibular nerve block has become passé.
Ultrasound-guided maxillary nerve block: an anatomical study using the suprazygomatic approach. [2021]Although a maxillary nerve (MN) block reportedly provides satisfactory analgesia for midface surgery and chronic maxillofacial pain syndromes, a safe and reliable MN block technique has not been reported. The goal of this anatomical study was to quantify the various angles and depth of the block needle, as well as to evaluate the impact of volume on the extent of injectate spread that might influence anesthetic coverage and block-related complications.
Advantages of anterior inferior alveolar nerve block with felypressin-propitocaine over conventional epinephrine-lidocaine: an efficacy and safety study. [2020]Conventional anesthetic nerve block injections into the mandibular foramen risk causing nerve damage. This study aimed to compare the efficacy and safety of the anterior technique (AT) of inferior alveolar nerve block using felypressin-propitocaine with a conventional nerve block technique (CT) using epinephrine and lidocaine for anesthesia via the mandibular foramen.
Regional Anesthesia for Orthobiologic Procedures. [2022]Peripheral nerve blocks (PNB) can lessen procedural pain and eliminate the known detrimental effects of our local anesthetics on our orthobiologic target tissues. Local nerve damage and local anesthetic systemic toxicity are risks of PNBs that can be minimized with meticulous injection technique and an understanding of why these complications can occur. Herein, several PNB techniques are described in an effort to enhance procedural safety, efficacy, and comfort.
An unusual complication of an inferior dental nerve block: a case report. [2009]Local anaesthetic drugs are commonly used in dental practice, with few complications. We describe an unusual complication of an inferior dental nerve block where, as the needle was advanced through the mucosa, the patient experienced profound numbness and skin pallor in the distribution of the infra-orbital nerve. We discuss the possible mechanism for this complication.
Post operative pain relief through intermittent mandibular nerve block. [2021]Mandibular nerve block is often performed for diagnostic, therapeutic and anesthetic purposes for surgery involving mandibular region. Advantages of a nerve block include excellent pain relief and avoidance of the side effects associated with the use of opiods or Non-steroidal anti-inflammatory drug (NSAIDs). A patient with maxillo facial trauma was scheduled for open reduction and internal fixation of right parasymphyseal mandibular fracture. The mandibular nerve was approached using the lateral extraoral approach with an 18-gauge i.v. cannula under general anesthesia. He received 4 ml boluses of 0.25% plain bupivacaine for intraoperative analgesia and 12 hourly for 48 h post operatively. VAS scores remained less than 4 through out observation period. The only side effect was numbness of ipsilateral lower jaw line, which subsided after local anesthetic administration was discontinued. Patient was discharged after four days.
Administering dental nerve blocks. [2007]Dental nerve blocks provide excellent pain management for many oral procedures. They are easy and inexpensive to perform, provide a rapid onset of action, and work in concert with anesthetic and other analgesic modalities. This article explains how to administer various dental nerve blocks and discusses the indications and precautions associated with their use.
Making inferior alveolar nerve block more comfortable via computer-controlled local anesthetic delivery: A prospective clinical study. [2022]The fear of needle insertion and pain during anesthesia is a source of patient dissatisfaction in dentistry. Inferior alveolar nerve block (IANB) remains the most common type of block and is in itself painful. Computer-controlled local anesthetic delivery (CCLAD) has been proven to reduce the pain associated with injection of anesthetics in various blocks. However, the efficacy of CCLAD for IANB in adults remains unknown.
The effect of the twin block compared with trigger point injections in patients with masticatory myofascial pain: a pilot study. [2022]The twin block, a novel nerve block that blocks the deep temporal and masseteric branches of the trigeminal nerve, has been shown to be effective in the short-term management of masticatory myofascial pain. However, little is known about its effectiveness in long-term management. The objective of this study was to assess the efficacy of the twin block in comparison with trigger point injections for the treatment of masticatory myofascial pain.
Comparison of success rate and onset time of two different anesthesia techniques. [2019]Using local anesthetic is common to control the pain through blocking the nerve reversibly in dental procedures. Gow-Gates (GG) technique has a high success rate but less common. This study aimed to compare the onset time and success rate in GG and standard technique of inferior alveolar nerve block (IANB).