Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Acute Pain
Type
Interventional
Phase
Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Triple blind, randomized prospective pilot study comparing post wisdom molar extraction pain comparing placebo or Twin block local anesthetic nerve block injectionMasking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: The patient, Twin block administrator and assessor assessing jaw muscle pain will all be unaware of whether the patient received sterile saline (placebo) or local anesthetic in the Twin Block injection.Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Annually, over 3.5 million predominantly young and healthy individuals undergo outpatient third molar tooth extractions and routinely receive postoperative opioid prescription (Moore, Nahouraii et al. 2006). This procedure is among the most prevalent instances of opioid prescriptions to adolescents ...

Annually, over 3.5 million predominantly young and healthy individuals undergo outpatient third molar tooth extractions and routinely receive postoperative opioid prescription (Moore, Nahouraii et al. 2006). This procedure is among the most prevalent instances of opioid prescriptions to adolescents and is the subject of a national debate, given the CDC's mandate for minimizing the number and duration of opioid prescriptions (Volkow, McLellan et al. 2011, Dowell, Haegerich et al. 2016, Moore, Dionne et al. 2016). Targeting such a prevalent practice by supplementing postoperative analgesia with non-opioid options as well as optimizing and tracking opioid usage will significantly reduce prescription opioid use/misuse. The Twin Block is a local anesthetic nerve block that eases muscle pain emanating from the jaw muscles and has been anecdotally shown to be effective in relieving post-operative pain in patients who developed muscle pain following third molar extractions. However, the incidence of acute muscle pain following third molar extractions is not well established. Accordingly, the aims of this study are two-fold: A. Objectives This study has 2 objectives: 1) To estimate the incidence of acute muscle pain involving the temporalis and masseter muscles (the jaw closer muscles that are commonly implicated in resulting in jaw muscle pain), following third molar extractions and 2) Conduct a double-blind prospective study to compare the efficacy of Twin Block in relieving postextraction pain in those patients determined to experience muscle pain following the procedure B. Hypotheses / Research Question(s) Hypothesis 1: The incidence of post-third molar extraction muscle pain is at least 40% Hypothesis 2: Twin block reduces post-extraction muscle pain by 50% 1.2 Research Significance The twin block is a simple and effective local anesthetic nerve block for 'numbing' the innervation to the masseter and temporalis muscles, two key jaw clencher muscles, with emerging data corroborating efficacy in the diagnosis and management of both acute and chronic myogenous orofacial pain (Quek, Young et al. 2014, Ananthan et al. 2017). 1.3 Research Design and Methods The study is designed as a prospective evaluation of patients undergoing third molar extractions under intravenous sedation to identify those developing post-extraction muscle pain on the day following the procedure. Subsequently, such patients will be prospectively randomized to receive the Twin block to deliver either the dental local anesthetic or saline as a placebo. Post-injection muscle pain will be evaluated 15 minutes following the administration of the injection. All patients will be provided similar directions and prescriptions for pain management. All patients will be contacted to document/report their daily pain medications and queried one week after the extraction/s for their overall pain experience and any adverse effects from the injection.

Tracking Information

NCT #
NCT04880707
Collaborators
New Jersey Health Foundation
Investigators
Principal Investigator: Gayathri Subramanian, PhD, DMD Rutgers School of Dental Medicine, Newark NJ