MedPath

Enhanced Recovery Strategies in Elective Breast Surgery

Phase 4
Terminated
Conditions
Pain, Acute
Nausea
Satisfaction
Vomiting, Postoperative
Opioid Use
Registration Number
NCT03187080
Lead Sponsor
University of Wisconsin, Madison
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Terminated
Sex
Female
Target Recruitment
Not specified
Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Numerical Pain Scores, Rated by Patient on 0-10 Scale
Secondary Outcome Measures
NameTimeMethod
Numerical Pain Scores, Rated by Patient on 0-10 Scale;Time Spent in Each Phase of Care Prior to Discharge;Time to Discharge to Home;Analgesic Requirements Reported as the Number of Participants Who Were Still Taking Medications Post-Operatively Day 7;Post-operative Nausea and Vomiting (Subjective Report) Measured as the Mean Incidence Reported Post-Operatively Day 7;Anti-emetic Requirements Measured as Number of Participants Taking Anti-nausea Medication Post-Operatively Day 7;Patients' Assessment of Perceived Quality of Recovery Using Modified Quality of Recovery Survey (MQOR-40)
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