Comparing Exparel and Bupivacaine for Pain Control After Tooth Extraction
Exparel Versus Bupivacaine in Post-operative Pain Control Following Bilateral Third Molar Extractions: A Single-blind Randomized Clinical Trial
PHASE4 · Case Western Reserve University · NCT06547255
This study tests whether a new pain medication called Exparel works better than standard bupivacaine for controlling pain after having wisdom teeth removed.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Case Western Reserve University (other) |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06547255 on ClinicalTrials.gov |
What this trial studies
This prospective, randomized study aims to evaluate the effectiveness of liposomal bupivacaine (Exparel) compared to standard bupivacaine in managing postoperative pain following third molar extractions. Participants will receive either Exparel or standard bupivacaine after their surgery, and their pain levels and analgesic consumption will be monitored through electronic questionnaires for 96 hours post-procedure. The study focuses on assessing anesthetic parameters and overall pain management outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for bilateral third molar extraction under local anesthesia and general anesthesia.
Not a fit: Patients with allergies to amide-type local anesthetics or those who have recently used certain pain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing dental surgeries.
How similar studies have performed: Previous studies have shown promising results with liposomal bupivacaine in postoperative pain management, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and nonpregnant female adults (≥18 years of age) with American Society of Anesthesiologists physical status classification 1, 2, or 3 who were scheduled to undergo bilateral third molar extraction (extraction of all 4 third molars) under local anesthesia and general anesthesia Study participants were required to have full or partial bony impaction of both mandibular third molars. Exclusion Criteria: * history of allergy or contraindication to amide-type local anesthetics, epinephrine, or opioids a history of any disease or condition or recent use of any drug that, in the opinion of the investigator, might increase the risk of surgery or interfere with study evaluations any use of long-acting opioids, nonsteroidal anti-inflammatory drugs, aspirin, or acetaminophen within 3 days before screening or use of opioids within 24 hours of screening Patient that is pregnant or suspected to be pregnant Adults that cannot speak English, adults that are unable to consent on their own, or persons that are listed as vulnerable individuals will not be part of the study
Where this trial is running
Cleveland, Ohio
- Case Western Reserve University — Cleveland, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: Faisal Quereshy, MD — Case Western Reserve University
- Study coordinator: Sandra L Beauclair,, RN
- Email: slb239@case.edu
- Phone: 216-368-6749
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Liposomal Bupivacaine