Clinical trial NCT04414917: Reducing Opioid Use and Misuse After Wisdom Molar Extractions
Official title: Reducing Opioid Use/Misuse Through Better Pain Control and Active Pill Dispensing
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Pain, Postoperative
Keywords: Impacted third molar extraction
Acute pain management
Active pill dispenser
Opioid misuse reduction
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: iPill Dispenser
First posted: 2020-06-04
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized blind clinical trial of patients undergoing lower third molar extraction/s to evaluate the ability of the Twin block (local anesthetic nerve block) on side of extraction to reduce post-operative pain and pain medication utilization monitoring with an active pill dispenser
Primary purpose: TREATMENT

Brief summary: Reducing opioid prescription related use and misuse is a major focus for countering the national epidemic of opioid overdose and death. Annually, over 3.5 million predominantly young and healthy individuals undergo outpatient third molar ('wisdom tooth') tooth extractions under sedation and routinely receive postoperative opioid prescriptions. This procedure is among the most prevalent instances of opioid prescriptions dispensed to adolescents, a vulnerable population. This overuse can be minimized by bringing about immediate and sustained pain relief following extractions and by proper monitoring to regulate post-operative opioid usage.

The investigators developed the Twin block, a local anesthetic nerve block that rapidly eases pain from the 'closer' muscles of the jaw and showed its long-term effectiveness in patients with chronic jaw muscle pain. Administering the Twin block immediately following third molar extractions will be an innovative and effective modality to alleviate acute post-procedure pain experienced by the patient and hence reduce the need for post-operative opioid pain medication.

In order to tightly regulate when, how many and to whom the prescribed opioid pill is accessible, this study will utilize the iPill Dispenser®, an active pill dispenser. The iPill device, designated as a Class I 510(k) exempt device by the FDA, includes an App that utilizes biometric user authentication to operate a portable tamper-resistant, pre-calibrated device to regulate, deliver, and monitor opioid usage for pain, preventing overconsumption and diversion. The investigators further plan to 'track' pill swallowing by encapsulating the medication with an ingestible event marker (IEMs, FDA approved Class II device). The hypothesis of this study is that reduction in opioid prescription and its unwarranted use following third molar extractions can be achieved by a combination of Twin block, an active pill dispenser and ingestion tracking. The Specific Aims are:

Specific Aim 1. Compare highest pain after third molar tooth extractions, in patients with and without the twin block.

Specific Aim 2. Compare postoperative opioid consumption during the first 4 days following third molar tooth extractions between patients who got the twin block, with those who do not. Using the iPill dispenser and app and the IEM, the investigators will track opioid consumption for severe pain.

Detailed description: Reducing opioid prescription related use and misuse is a major focus for countering the national epidemic of opioid overdose and death. Annually, over 3.5 million predominantly young and healthy individuals undergo outpatient third molar ('wisdom tooth') tooth extractions and routinely receive postoperative opioid prescription (Moore, Nahouraii et al. 2006). This procedure is among the most prevalent instances of opioid prescriptions dispensed to adolescents and is the subject of a national debate, given the risk for persistent opioid use and abuse in a vulnerable population (Volkow, McLellan et al. 2011, Dowell, Haegerich et al. 2016, Groenewald, Rabbitts et al. 2016, Moore, Dionne et al. 2016, Harbaugh, Nalliah et al. 2018). The investigators believe that this overuse can be minimized by bringing about immediate and sustained pain relief following extractions and by proper monitoring to regulate post-operative opioid usage.

Prolonged mouth opening as well as eccentric and isometric contractions, as are typical during third molar tooth extraction procedures, can result in acute muscle pain in the masticatory or 'chewing' muscles. However, it is common practice to numb only the actual tooth extraction site for postoperative pain management, without evaluating for and addressing acute post-procedure muscle pain. The investigators' preliminary studies have corroborated the efficacy of the Twin block, a local anesthetic, in the diagnosis and management of acute and chronic myogenous orofacial pain stemming from the 'chewing muscles' (Quek, Young et al. 2014, Kanti, Ananthan et al. 2017). The investigators expect that administering the Twin block immediately following third molar extractions, will be an innovative and effective modality to alleviate acute post-procedure pain experienced by the patient and hence reduce the need for post-operative opioid pain medication. Our hypothesis, therefore, is that reduction in opioid prescription and unwarranted use can be achieved by a combination of Twin block and an actively monitored pill dispenser. We have selected the iPill Dispenser® to monitor and regulate post-operative usage.

The iPill device includes an App that utilizes biometric user authentication to operate a portable tamper-resistant, pre-calibrated device to regulate, deliver, and monitor opioid usage for pain, preventing overconsumption and diversion. Coencapsulating the pain pill with the IEM will create a virtual 'time-stamp' by triggering a wireless signal from the IEM, when contacted by stomach acid content, which is detected by a sensor secured on the skin with an adhesive strip.

Therefore, the Specific Aims are:

Specific Aim 1. Compare peak postoperative pain after third molar tooth extractions, with and without the twin block, in a randomized blind prospective clinical study Patients undergoing third molar tooth extractions under 'moderate' (intravenous) sedation, will be randomized to receive either the twin block or a sham injection on the side of their extraction/s. The Twin block and sham injection groups will be compared for peak postoperative pain measured using the numerical pain rating scale (NRS). The investigators predict at least a 50% reduction in percentage of patients reporting significant pain (NRS≥5), in the group randomized to receive the twin block.

Specific Aim 2. Compare postoperative opioid consumption during the first 96 hours following third molar tooth extractions between patients randomized to the control or twin block groups Using the iPill dispenser and app, the investigators will track IEM-co-encapsulated opioid consumption for severe pain among patients randomized to either the sham or Twin block arms. The investigators predict at least a 30% reduction in opioid consumption for severe pain in the group randomized to receive the Twin block. The investigators expect that utilizing the iPill dispenser® and app will enforce rigorous, real-time and accurate monitoring of opioid usage for pain management, overcoming the traditional reliance on patient-reported usage.

POSSIBLE OUTCOMES: This research will potentially transform conventional postoperative pain management following third molar ('wisdom' tooth) extractions. The investigators expect the routine incorporation of the twin block to alleviate post-operative pain, thereby reducing the current reliance on opioid prescriptions in a vulnerable population, especially after a commonplace procedure.

Eligibility criteria: Inclusion Criteria:

1. Adults (\> 18)
2. American Society of Anesthesiologists Classification I
3. No h/o temporomandibular disorder (TMD) symptoms
4. No h/o trauma to jaws/teeth
5. No h/o surgery in maxillofacial region
6. Presenting for extraction of at least 1 mandibular partially bony/ full bony impacted 'wisdom' or third molar/s under intravenous sedation
7. iPhone or Android smart phone (compatible with iPill® App)
8. Informed consent
9. No cognitive/intellectual disability
10. Not from vulnerable population

Exclusion Criteria:

1. Acute infection or pain in relation to the impacted molars on day of procedure
2. h/o opioid prescription for acute/chronic pain
3. h/o of allergy or contraindication to amide-type local anesthetics, epinephrine or opioids
4. Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs)/muscle relaxants/other prescriptions to manage pain/inflammation
5. Refusal/inability to use iPill® App or dispenser
6. h/o eczema

Primary outcomes:
measure: Numerical Pain Rating Scale score (NRS)
timeFrame: Change in NRS pain scores between baseline and 96 hours post-pain regimen assignment
measure: Pain medication consumed (mg)
timeFrame: Through 96 hours post-procedure
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: During the first 4 days following procedure
measure: iPill Dispenser performance- Validation of pills dispensed
timeFrame: During the first 4 days following procedure
measure: iPill Dispenser performance- Incidence of dispenser tampering
timeFrame: During the first 4 days following procedure
measure: iPill Dispenser performance- Incidence of failure of operability
timeFrame: During the first 4 days following procedure
measure: iPill Dispenser performance- Percentage of returned dispensers
timeFrame: During the first 4 days following procedure
measure: IEM relayed record of pill ingestion
timeFrame: During the first 4 days following procedure
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers Health University Dental Associates
state: New Jersey
Study officials:
affiliation: Rutgers School of Dental Medicine
name: Gayathri Subramanian, PhD DMD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rutgers School of Dental Medicine
name: Anayo Adachie, DMD, MD
role: PRINCIPAL_INVESTIGATOR
References: