Ignite Creation Date:
2024-05-06 @ 4:08 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04880707
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-05
First Post:
2021-05-05
Brief Title:
Twin Block Pain Medications and Third Molar Extractions
Sponsor:
Rutgers The State University of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Myogenous Face Pain Following Third Molar Extractions Under Intravenous Sedation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Each year over 35 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
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
Detailed Description:
Annually over 35 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 CDCs 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 usemisuse 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 Questions 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 12 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 13 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 documentreport their daily pain medications and queried one week after the extractions for their overall pain experience and any adverse effects from the injection
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 Questions 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 12 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 13 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 documentreport their daily pain medications and queried one week after the extractions for their overall pain experience and any adverse effects from the injection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None