Enhanced Recovery Strategies in Elective Breast Surgery
common.study.values.description
“Enhanced Recovery Strategies in Elective Breast Surgery”
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.
common.study.values.location
participant.ui.study.affiliations-map.online-study.header-virtual
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common.study.values.methods
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common.study.methods.is-healthy-no
Procedure - Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline
Paravertebral block (PVB) will be performed in the standard fashion using an out-of-plane ultrasound approach by an anesthesiologist with appropriate training in regional anesthesia. Landmarks on the patient will be identified. The skin will be sterilized. The intended target (paravertebral space) will be located using an ultrasound. A Pajunk UniPlex NanoLine needle will be inserted. A syringe filled with sterile saline (used for hydrodissection) connected to a syringe of 0.25% bupivacaine with ...read more on ClinicalTrials.org
Enhanced recovery after breast surgery (ERABS) strategies
For comparing ERABS strategies to our current standard of care, we will utilize the following perioperative strategies [Arsalani]: Standardized written information given preoperatively. Allow clear liquids for up to 2 hours prior to arrival at the surgery center. Use paravertebral block to augment postoperative pain control. Standardized multimodal analgesic regimen Antiemetics Easily accessible call-in or walk-in postop care/support The proposed strategies differ from standard of care in the fo ...read more on ClinicalTrials.org
Procedure - Sham paravertebral block using saline
Paravertebral block (PVB) will be performed in the standard fashion using an out-of-plane ultrasound approach by an anesthesiologist with appropriate training in regional anesthesia. Landmarks on the patient will be identified. The skin will be sterilized. The intended target (paravertebral space) will be located using an ultrasound. A Pajunk UniPlex NanoLine needle will be inserted. A syringe filled with sterile saline (used for hydrodissection) connected to a syringe of sterile saline will be ...read more on ClinicalTrials.org
Drug - Paravertebral block using local anesthetic
Use of local anesthetic (0.25% bupivacaine) that is *NOT* an experimental drug but will be used as part of the paravertebral block to provide local anesthetic. This will not be given to those in the sham block groups.
participant.views.study.view.additional
participant.views.study.view.scientific-title
Evaluating the Use of Enhanced Recovery Strategies and Paravertebral Block in Elective Breast Reduction and Breast Augmentation
common.study.values.clinical-trial-id
NCT03187080
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9b6wnd
