Evaluating the Use of Enhanced Recovery Strategies and Paravertebral Block in Elective Breast Reduction and Breast Augmentation

2016-1388

Postoperative pain, nausea, and vomiting are frustrating sequelae of elective breast surgery. Poorly managed postoperative pain can lead to increased opioid use, increased postoperative nausea and vomiting (PONV), delayed return to work and usual activities, unplanned hospital admissions, surgical complications, and patient dissatisfaction. In light of the growing opioid epidemic in the United States, any intervention that potentially minimizes opioid use may have meaningful individual and societal impact. In patients undergoing breast reduction and breast augmentation surgery, multiple techniques for managing postoperative pain are used commonly. One such technique is the use of a paravertebral block (PVB), which is a method of injecting local anesthesia into the area surrounding the spinal nerves in order to decrease sensation and pain in the chests and breasts in the setting of breast surgery. PVB is generally used concomitantly with standard multimodal perioperative pain management including cool compress, non-steroidal anti-inflammatories (NSAIDs), acetaminophen, and opioids. All of these pain management strategies are used at the University of Wisconsin and are considered standard of care for breast surgery nationwide. The overall purpose of this study is to evaluate interventions that aim to optimize pain control, minimize the risk of PONV, and improve recovery after elective breast surgery. We will do this by (1) Comparing PVB with standard pain management strategies in patients undergoing planned breast reduction and breast augmentation, and (2) Comparing "enhanced recovery after surgery" (ERAS) strategies to standard of care for patients undergoing planned breast reduction and breast augmentation. This will be studied using pain assessments, validated surveys, medication logs, and review of medical records.

2024-04-01

2026-04-01

2026-04-01

Early phase I

296

Inclusion Criteria: * Age equal to and greater than 18 years. * Medically cleared to undergo elective breast surgery (including associated anesthesia) at UW Transformations Surgery Center or Madison Surgery Center (MSC). * Undergoing bilateral breast augmentation or bilateral breast reduction by the PI (Dr. Venkat Rao). Exclusion Criteria: * Minors or under the age of 18 * Pregnant or breast feeding women * Incarcerated women * Males * Individuals unable to give consent due to another condition such as impaired decision-making capacity. * Women who take opioid pain medications on a regular basis prior to surgery. * Women with a history of opioid abuse and/or dependence. * Women who, based on anesthesiologist discretion, are not candidates for paravertebral block. * Women with BMI \>35 * Women with a diagnosis of obstructive sleep apnea who are noncompliant with their treatment (e.g. CPAP use). * Women with a history of bleeding disorders precluding safe paravertebral block. * Women on anticoagulation therapy who have not held their anticoagulation as recommended by their surgeon or anesthesiologist. * Women with a history of infection at the site of paravertebral block. * Women not medically cleared for surgery at Transformations or MSC and thus would not be undergoing surgery at Transformations or MSC. This would include women with sepsis/bacteremia, significant valvular disorders or heart conditions.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': "There are four serial aims of this study. The overarching goal is to prospectively assess the use of PVB as an adjunct for postoperative pain control both alone and in the setting of related ERABS strategies in elective breast surgery (both breast reduction and breast augmentation, two of the most common non-oncologic breast operations performed in an ambulatory setting). The methodologies used to assess postoperative pain, the set of collective ERABS strategies, the potential risks and benefits of study participation, and the inclusion/exclusion criteria will be the same in the groups studying breast reduction and those studying breast augmentation. As both operations are performed on a regular basis in the PI's practice, we feel it essential to evaluate both operations.", 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Participants will be blinded as to which treatment arm within their group that they are allocated. The surgery team including the surgeon (PI) and resident will be blinded as well. Anesthesiologists will not be blinded.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 296, 'type': 'ESTIMATED'}}

2024-04-18