Randomized Controlled Trial Evaluating Liposomal Bupivacaine Following Abdominoplasty

2019-1570

The overall purpose of this study is to evaluate the analgesic efficacy of liposomal bupivacaine in optimizing pain control, minimizing the risk of postoperative nausea and vomiting (PONV), and improving recovery after abdominoplasty. This will be done by comparing intraoperative abdominal wall and incisional injection of bupivacaine to bupivacaine plus liposomal bupivacaine in 46 participants 18 years and older undergoing elective abdominoplasty. This will be studied using pain assessments, validated surveys, medication logs and review of medical records.

2021-01-05

2024-08-01

2024-08-01

Early phase I

46

Inclusion Criteria: * Medically cleared to undergo elective surgery (including associated anesthesia) at UW Madison Surgery Center (MSC). Exclusion Criteria: * Pregnant or breast-feeding women * Incarcerated women or men * Individuals unable to give consent due to another condition such as impaired decision-making capacity. * Men or women who take opioid pain medications on a regular basis prior to surgery * Men or women with a history of opioid abuse and/or dependence * Participants with a history of bleeding disorders precluding safe abdominoplasty * Participants on anticoagulation therapy who have not held their anticoagulation as recommended by their surgeon or anesthesiologist * Participants not medically cleared for surgery at Madison Surgery Center. This would include participants with sepsis/bacteremia, significant valvular disorders or heart conditions.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 46, 'type': 'ESTIMATED'}}

2023-09-29