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Local Anesthetic Nerve Block

Opioid Management Strategies for Postoperative Pain

Phase 2
Waitlist Available
Led By Anayo Adachie, DMD, MD
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presenting for extraction of at least 1 mandibular partially bony/full bony impacted 'wisdom' or third molar/s under intravenous sedation
No history of temporomandibular disorder (TMD) symptoms
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 96 hours post-procedure
Awards & highlights

Study Summary

This trial will test whether or not the twin block, an active pill dispenser, and ingestion tracking can reduce opioid prescription and its unwarranted use following third molar extractions.

Who is the study for?
Adults over 18 without a history of jaw disorders, trauma, or surgery in the maxillofacial area who are getting at least one 'wisdom' tooth removed. Participants must be healthy (ASA I), able to consent, not part of a vulnerable population, and have a compatible smartphone for the iPill App.Check my eligibility
What is being tested?
The study tests if using Twin block anesthesia can reduce pain after wisdom tooth removal and decrease opioid use when paired with an iPill dispenser that controls pill access. Pain levels and opioid consumption will be compared between patients with and without Twin block.See study design
What are the potential side effects?
Potential side effects may include typical reactions to local anesthetics like numbness or tingling around the mouth, allergic reactions although rare, as well as issues related to opioids such as nausea, drowsiness or risk of dependency.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am getting at least one lower wisdom tooth removed under sedation.
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I have never had symptoms of jaw joint (TMD) problems.
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I am over 18 years old.
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I have never had any injuries to my jaws or teeth.
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I have never had surgery in the jaw or face area.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 96 hours post-procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and through 96 hours post-procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Numerical Pain Rating Scale score (NRS)
Pain medication consumed (mg)
Secondary outcome measures
IEM relayed record of pill ingestion
Incidence of adverse events
iPill Dispenser performance- Incidence of dispenser tampering
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Twin Block local anestheticExperimental Treatment2 Interventions
Patients undergoing extractions of lower wisdom molar/s under intravenous sedation will receive the Twin block local anesthetic (using the standard dental anesthetic 1.8 cc 2% lidocaine with 1:100,000 epinephrine), once, on the side/s of their extraction/s
Group II: ControlPlacebo Group1 Intervention
Patients undergoing extractions of lower wisdom molar/s under intravenous sedation will receive the Twin block injection but with no medication administered/dispensed from the syringe, on the side/s of their extraction/s
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Twin block
2018
N/A
~80

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
424 Previous Clinical Trials
64,000 Total Patients Enrolled
iPill DispenserUNKNOWN
Anayo Adachie, DMD, MDPrincipal InvestigatorRutgers School of Dental Medicine

Media Library

Twin block (Local Anesthetic Nerve Block) Clinical Trial Eligibility Overview. Trial Name: NCT04414917 — Phase 2
Postoperative Pain Research Study Groups: Twin Block local anesthetic, Control
Postoperative Pain Clinical Trial 2023: Twin block Highlights & Side Effects. Trial Name: NCT04414917 — Phase 2
Twin block (Local Anesthetic Nerve Block) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04414917 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research venture recruiting new patients?

"The information on clinicaltrials.gov reveals that the recruitment phase of this medical trial has ended, as it was last updated on January 26th 2022. Despite this, there are still 483 other studies currently seeking participants."

Answered by AI

What kind of results is this research striving to achieve?

"The primary goal of this study is to monitor the change in NRS pain scores between baseline and 96 hours post-pain administration. Secondary objectives include assessing any adverse events, evaluating failure of operability by measuring frequency of failed pill dispensing, as well as detecting tampering upon inspection of returned iPill Dispensers."

Answered by AI

Is the Twin block method of treatment safe and reliable?

"Based on the Phase 2 status of this trial, we have assessed Twin block's safety as a score of two. While there is some evidence that it is safe to use, no data exists yet proving its efficacy."

Answered by AI
~78 spots leftby Nov 2024