Enhanced Recovery Strategies in Elective Breast Surgery

Summary

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. The investigators 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.

Conditions

• Pain, Acute
• Nausea
• Vomiting, Postoperative
• Opioid Use
• Satisfaction

Interventions

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 2.5 mcg/mL of epinephrine will be connected to the Pajunk needle and used for injection. The needle will be advanced toward and through the superior costotransverse ligament or internal intercostal membrane. Once through the ligament, the pleura will be seen deflecting anteriorly with the hydrodissection. Negative aspiration will be confirmed, and the local anesthetic will be injected into the paravertebral space.

OTHER

Enhanced recovery after breast surgery (ERABS) strategies

For comparing ERABS strategies to current standard of care, the following perioperative strategies will be utilized: * 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 following ways: * PVB is less commonly used in elective surgery. * Patients do not eat or drink after midnight. * There is no standardized preoperative information packet. * Anesthetic/intraoperative analgesic and antiemetic regimen varies between providers.

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 connected to the Pajunk needle and used for injection. The needle will be advanced toward and through the superior costotransverse ligament or internal intercostal membrane. Once through the ligament, the pleura will be seen deflecting anteriorly with the hydrodissection. Negative aspiration will be confirmed, and the local anesthetic will be injected into the paravertebral space.

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.

Sponsors & Collaborators

• University of Wisconsin, Madison

  lead OTHER

Principal Investigators

• Venkat K Rao, MD, MBA · University of Wisconsin, Madison

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-10-19

Primary Completion

2021-06-15

Completion

2021-06-15

FDA Drug

Yes

Countries

• United States

Study Locations