Liposomal Bupivacaine
Conditions
Brief summary
This is a prospective, randomized study to evaluate anaesthetic parameters, postoperative analgesia and oral analgesic consumption comparing exparel (liposomal bupivacaine) vs. standard bupivacaine
Detailed description
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
Interventions
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.
Sponsors
Case Western Reserve University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post Operative Pain Intensity (Visual Analog Scale VAS) | Twice daily (morning and evening) from 0-96 hours post-operatively | Post operative pain was assessed using 0-10 Visual Analog Scale (VAS) where 0 indicates no pain and 10 indicates worse imaginable pain. Patients recorded pain score twice daily (morning and evening) for four consecutive post operative days using a standardized at home questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post Operative NSAID/Acetaminophen Consumption | Daily from 0 to 96 hours post-operatively | Post operative analgesic consumption was recorded using a standardized at home questionnaire. Patients document the number of NSAIDS (Ibuprofen 600mg) and Acetaminophen tablets taken daily for four consecutive postoperative days. |
| Post Operative Opioid Consumption (Hydrocodone-Acetaminophen 5/325) Use | daily from 0 to 96 hours post-operatively | post operative opioid consumption was recorded using a standardized at home qusetionnaire. patients documented the number of (Hydrocodone-Acetaminophen 5/325) tablets taken daily for four consecutive postoperative days |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORFaisal Quereshy, MD
Case Western Reserve University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 24.4 years STANDARD_DEVIATION 6.9 |
| ASA Physical status classification ASA I | 47 Participants |
| ASA Physical status classification ASA II | 3 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 42 |
| other Total, other adverse events | 7 / 40 | 5 / 42 |
| serious Total, serious adverse events | 0 / 40 | 0 / 42 |
Outcome results
None listed