Reducing Pain From Wisdom Molar Extractions

NCT ID: NCT05335070

Last Updated: 2024-12-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-13
• Study Completion Date: 2026-01-31

Brief Summary

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.

Detailed Description

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 Temporo-masseteric Nerve Block (TMNB) dental anesthetic injection (This was called the Twin Block earlier). The TMNB 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 TMNB 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.

In this pilot study, the investigators will deliver the Temporo-masseteric Nerve Block (TMNB) injection to 20 individuals (study participants) who undergo extraction of at least 1 lower wisdom molar dental extraction under intravenous sedation, on the side/s of lower molar removal at the end of the procedure. The participant's pain experience, medications taken for pain, as well as any adverse effects from either pain medications or the TMNB injection will be queried for a period of 1 week following the procedure (remotely). On Day 8 (one week after the procedure), the participants will return for a follow-up visit. The participants' pain experience will be compared with historical controls. This study can support a simple, safe and inexpensive means to reduce pain after a common procedure and will provide proof-of-concept for the potential non-opioid analgesic role of TMNB injection following wisdom molar removal.

The participant will be advised to take a combination of ibuprofen and acetaminophen (600 mg ibuprofen and 325 mg acetaminophen) every 4-6 hours for pain, unless it is mild, for which OTC strength analgesics would prove adequate (ibuprofen or acetaminophen). 5/300 mg hydrocodone with acetaminophen will be utilized for pain management if the patient's pain does not respond to 600 mg ibuprofen and 325 mg acetaminophen, even an hour after medication.

The key outcomes collected will include peak-pain by 4 hours post-procedure (measured using numerical pain rating scale score NRS, from 0-10, with 0 corresponding to no pain, 1-3 corresponding to mild, 4-6 to moderate and 7-10 to severe pain), passive mouth opening, masticatory muscle pain to palpation (masseter and temporalis muscles), total dosage of pain medication/s consumed. Adverse effects to pain medication consumption (nausea/ drowsiness/ gastritis etc) or to the TMNB injection will also be recorded. Daily pain experience will be recorded each of the 7 days post-operatively either as a survey emailed to the participant or queried over the phone by research personnel.

A week after the procedure, the participant will present for a post-operative evaluation. The extraction/s site/s will be evaluated for any infection/delayed healing.

Conditions

Acute Pain

Keywords

Temporo-masseteric Nerve Block; Twin Block; Prescription opioids; Acute Post-extraction pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Temporo-masseteric Nerve Block (TMNB) Injection with Local Anesthetic

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

Group Type: EXPERIMENTAL

Temporo-masseteric Nerve Block

Intervention Type: DRUG

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 the lower wisdom molar (third molar) extraction/s

Interventions

Temporo-masseteric Nerve Block

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 the lower wisdom molar (third molar) extraction/s

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age 18 years of age or older (up to 64 years)
• Any demographic
• ASA 1 and 2 (mild or absent systemic illnesses, deemed fit for undergoing dental extractions under intravenous sedation)
• Not pregnant (as will not qualify to undergo procedure under intravenous sedation as part of routine standard-of-care)
• Adequate mental ability to understand and provide informed consent
• Has smart phone and internet connection

Exclusion Criteria

• Age older than 64 years (because they are poor candidates for undergoing procedures under intravenous sedation)
• Pregnant
• Incapable of providing informed consent
• Any systemic condition that renders the patient at higher risk for complications under intravenous sedation
• Documented allergy to the dental local anesthetic
• Inability to tolerate any of the commonly used pain medications such as combination opioids, acetaminophen (Tylenol®) or ibuprofen (Motrin® or Advil®)
• Limitation in adequate mouth opening in presence/absence of pain

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Gayathri Subramanian

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gayathri D Subramanian, PhD, DMD

Role: PRINCIPAL_INVESTIGATOR

Rutgers School of Dental Medicine

Locations

The University Hospital- Dental Clinic

Newark, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Gayathri Subramanian, PhD, DMD

Role: CONTACT

Phone: 9739723418

Email: subramga@sdm.rutgers.edu

Samuel YP Quek, DMD, MPH

Role: CONTACT

Phone: 732 570 1996

Facility Contacts

Gayathri Subramanian

Role: primary

References

Quek SYP, Gomes-Zagury J, Subramanian G. Twin Block in Myogenous Orofacial Pain: Applied Anatomy, Technique Update, and Safety. Anesth Prog. 2020 Jun 1;67(2):103-106. doi: 10.2344/anpr-67-01-03.

Reference Type: BACKGROUND

PMID: 32633773 (View on PubMed)

Kanti V, Ananthan S, Subramanian G, Quek SYP. Efficacy of the twin block, a peripheral nerve block for the management of chronic masticatory myofascial pain: A case series. Quintessence Int. 2017 Oct 6:725-729. doi: 10.3290/j.qi.a39094. Online ahead of print.

Reference Type: BACKGROUND

PMID: 28990015 (View on PubMed)

Quek S, Young A, Subramanian G. The twin block: a simple technique to block both the masseteric and the anterior deep temporal nerves with one anesthetic injection. Oral Surg Oral Med Oral Pathol Oral Radiol. 2014 Sep;118(3):e65-7. doi: 10.1016/j.oooo.2014.01.227. Epub 2014 Feb 6.

Reference Type: BACKGROUND

PMID: 24703404 (View on PubMed)

Other Identifiers

Pro2021002543

Identifier Type: -

Identifier Source: org_study_id