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This is a prospective, randomized study to evaluate anaesthetic parameters, postoperative analgesia and oral analgesic consumption comparing exparel (liposomal bupivacaine) vs. standard bupivacaine
The main purpose of this prospective, randomized study was to evaluate anaesthetic parameters, postoperative analgesia and oral analgesic consumption comparing exparel (liposomal bupivacaine) vs. standard bupivacaine. At the end of the third molar extraction surgical procedure and at least fifteen minutes following the most recent administration of 2% lidocaine with 1:100,000 epinephrine (routine for this procedure), patients will, at random, receive mandibular and maxillary infiltrations with 3mL of 1.3% liposomal bupivacaine (Exparel) or with standard 3mL standard bupivacaine. Electronic home questionnaires will be completed by the patient following the procedure for 96 hours to evaluate these clinical parameters
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard bupivicaine | Active Comparator | patient receive mandibular and maxillary infiltrations with 3mL of standard 3mL standard bupivacaine. |
|
| liposomal bupivacaine | Experimental | patient receive mandibular and maxillary infiltrations with 3mL of 1.3% liposomal bupivacaine (Exparel) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine liposome injectable suspension | Drug | At the end of the third molar extraction surgical procedure performed under general anesthesia and at least fifteen minutes following the most recent administration of 2% lidocaine with 1:100,000 epinephrine nerve block (routine for this procedure), all patients will receive bilateral infiltrations with 3mL of 1.3% liposomal bupivacaine (Exparel) OR with 3mL of 0.5% bupivacaine with 1:200,000 epinephrine while they are still under general anesthesia. |
| Measure | Description | Time Frame |
|---|---|---|
| post operative pain | At home questionnaire with a numerical scale (0 - 10), to be completed each morning and evening for four days post-operative | 96 hours post-operatively |
| Adverse effects | At home questionnaire including the presence or absence of any abnormal sensations, change in taste, nausea, constipation, fever, diaphoresis, vomiting, light-headedness, palpitations, or headache. | 96 hours post-operatively |
| NSAID/Acetaminophen use | Ibuprofen 600mg [Advil], Tylenol) Use | 96 hours post-operatively |
| Norco 5/325 (Hydrocone-Acetaminophen) Use | At home questionnaire including the dosage, time, quantity and reason for use | 96 hours post-operatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Faisal Quereshy, MD | Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 3, 2026 | Jun 26, 2026 | 5 | ||
| Jun 30, 2026 |
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