Exparel Versus Bupivacaine in Post-operative Pain Control
- Conditions
- Liposomal Bupivacaine
- Interventions
- Registration Number
- NCT06547255
- Lead Sponsor
- Case Western Reserve University
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description standard bupivicaine Bupivacaine liposome injectable suspension patient receive mandibular and maxillary infiltrations with 3mL of standard 3mL standard bupivacaine. liposomal bupivacaine Bupivacaine liposome injectable suspension patient receive mandibular and maxillary infiltrations with 3mL of 1.3% liposomal bupivacaine (Exparel)
- Primary Outcome Measures
Name Time Method post operative pain 96 hours post-operatively At home questionnaire with a numerical scale (0 - 10), to be completed each morning and evening for four days post-operative
NSAID/Acetaminophen use 96 hours post-operatively Ibuprofen 600mg \[Advil\], Tylenol) Use
Adverse effects 96 hours post-operatively 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.
Norco 5/325 (Hydrocone-Acetaminophen) Use 96 hours post-operatively At home questionnaire including the dosage, time, quantity and reason for use
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Case Western Reserve University
🇺🇸Cleveland, Ohio, United States