Post Operative Pain
Conditions
Brief summary
The most prevalent complaint after third molar extractions is pain. There have been many modalities and regimens developed to manage post-operative pain, such as modifications in surgical techniques, locally-applied medicaments, and oral analgesics. Recently, liposomal bupivacaine (Exparel) has been FDA approved for single-dose infiltration in the oral cavity in adults and children (6 years or older) to produce extended postsurgical local anesthesia. We hypothesize that the administration of liposomal bupivacaine (Exparel) at the end of third molar extractions will decrease postoperative pain and decrease narcotic use for pain management.
Detailed description
In this study, we will prospectively collect data from all patients receiving bilateral third molar extractions with Exparel versus 0.5% bupivacaine 1:200,000 epinephrine (standard bupivacaine) injections to determine the efficacy of Exparel in reducing postoperative pain. Outcomes measured will be pain intensity based on a numeric scale, date and time when pain completely subsides for each side, adverse events, use of NSAID or acetaminophen outside of prescribed pain regimen, and use of narcotics. The purpose of this research project is to evaluate the use and efficacy of Exparel in postoperative pain management in third molar extractions.
Interventions
DRUGLiposomal bupivacaine
Dosage: 3 mL Frequency: Administer via buccal infiltration technique immediately following mandibular third molar extraction surgery and at least twenty minutes following most recent lidocaine injection.
DRUG0.5% bupivacaine with 1:100,000 epinephrine
Dosage: 3 mL of diluted 0.5% bupivacaine with 1:200,000 epinephrine (2:1 ratio of saline to standard bupivacaine) Frequency: Administer via buccal infiltration technique immediately following mandibular third molar extraction surgery and at least twenty minutes following most recent lidocaine injection.
Sponsors
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
An envelope, which is identified by the patient specific study ID, will contain Exparel and standard bupivacaine syringes. The syringes will be masked and labeled left or right, depending on the randomization results. Designated dental assistants not associated with the study will receive the corresponding envelope to prepare the syringes. Syringes containing the solutions will be masked so that the operator would not be able to detect which solution is being infiltrated.
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients receiving bilateral mandibular third molar extractions at the Herman Ostrow School of Dentistry by an oral \& maxillofacial surgery resident.
Exclusion criteria
* Patient unable to complete form for four days postoperatively. * Patient with severe hepatic disease * Patient with a history of allergy or contraindication to amide-type LA or opioids * Patient with recent history of antibiotic use within the past thirty days * Patients with use of long-acting opioids, NSAIDs, aspirin, acetaminophen within 3 days prior to screening. * Patients who are pregnant. * Patients receiving additional mandibular teeth extractions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Pain | Mean Area under Curve Numeric rating scale scores 96 hours post-operatively | At home questionnaire with a numerical scale (0 - 10 with 0 being least amount of pain and 10 being most amount of pain), to be completed each morning and evening for four days post-operative. Then the cumulative pain rating using the numeric rating scale area under the curve over 96 hours (0 - 960 with 0 being least amount of pain over 96 hours and 960 being the most amount of pain over 96 hours), scaled at the hour-level, is calculated using the trapezoidal method in the caTools package in R, which is a sum of the averages of the numeric rating scale. A higher value is a worse outcome and lower value is a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NSAID/Acetaminophen Use | 96 hours post-operatively | Number of Participants with NSAID/Acetaminophen Use |
| Oxycodone Use | 96 hours post-operatively | Number of Participants with oxycodone Use |
Countries
United States
Participant flow
Pre-assignment details
The initial sample included in the study was composed of 85 subjects. There were 10 subjects who did not return their questionnaire after enrolling in the study, one subject who completed the questionnaire incorrectly and was disqualified, one subject who was excluded due to opioid use during the postoperative period and one subject who was excluded due to postoperative alveolar osteitis.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 25.8 years STANDARD_DEVIATION 9 |
| Region of Enrollment United States | 72 Participants |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 72 | 0 / 72 |
| other Total, other adverse events | 26 / 72 | 26 / 72 |
| serious Total, serious adverse events | 0 / 72 | 0 / 72 |
Outcome results
None listed