Acute Pain Clinical Trial
Official title:
Non-randomized Prospective Pilot Study on Effect of Temporo-masseteric Nerve Block (TMNB) on Pain Reduction Following Wisdom Molar Extractions
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | January 2025 |
Est. primary completion date | November 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | The University Hospital- Dental Clinic | Newark | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Rutgers, The State University of New Jersey |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Peak post-operative Pain Score | Every 30 minutes, the patient's pain score (Numerical Pain Rating Scale with scores from 0-10, (the NRS scale), with 0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= severe pain) will be recorded to document peak pain score by hour 4. If the patient were to report a score from 7-10 at any time, no additional delay/pain score enquiry will take place and the patient will be directed to take the first dose of post-operative pain medication as described elsewhere. | up to 4 hours on day of procedure, post-procedure | |
Primary | Mean Numerical Pain Rating Scale pain score | The average pain score reported by the patient during the entire post-operative week will be assessed | One week | |
Primary | Passive Mouth opening | Passive mouth opening will be measured (in mm) at baseline, post-procedure before as well as 15 min after TMNB injection and finally, during the post-operative visit (Day 8) will be measured | Baseline, post-procedure (Day 1) and at post-operative visit (Day 8) | |
Primary | Masticatory muscle pain to palpation- Temporalis and Masseter | Numerical pain rating scale pain scores reported by the patient upon palpation of the masseter and temporalis muscles will be recorded at baseline, post-procedure (before and 15 min after TMNB injection) and at the post-operative visit one week after procedure | Baseline, post-procedure (Day 1) and at post-operative visit (Day 8) | |
Primary | Total dose of pain medication- acetaminophen, ibuprofen and hydrocodone | Total dose of pain medications consumed over the first post-operative week, for each of the medications will be recorded in mg | 8 Days | |
Primary | Adverse effects | The patient will be queried each day for any adverse effects from pain medications and any adverse effects at the site of injection (infection, pain etc) | 8 days |
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