Enhanced Recovery Strategies in Elective Breast Surgery
Pain, Acute, Nausea, Vomiting, Postoperative
About this trial
This is an interventional treatment trial for Pain, Acute
Eligibility Criteria
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.
Sites / Locations
- University of Wisconsin Madison
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Experimental
Sham Comparator
Experimental
Sham Comparator
Experimental
No Intervention
Experimental
No Intervention
Group 1 Arm A
Group 1 Arm B
Group 2 Arm A
Group 2 Arm B
Group 3 Arm A
Group 3 Arm B
Group 4 Arm A
Group 4 Arm B
Breast reduction with Paravertebral block using local anesthetic.
Breast reduction with Sham paravertebral block using saline.
Breast augmentation with Paravertebral block using local anesthetic.
Breast augmentation with Sham paravertebral block using saline.
Breast reduction with Enhanced recovery after breast surgery (ERABS) strategies.
Breast reduction, standard perioperative management.
Breast augmentation with Enhanced recovery after breast surgery (ERABS) strategies.
Breast augmentation, standard perioperative management.