Study: NCT03187080

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline
Description: 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.

Intervention type: PROCEDURE
Group type: SHAM_COMPARATOR
Intervention: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline
Description: 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.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline
Description: 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.

Intervention type: PROCEDURE
Group type: SHAM_COMPARATOR
Intervention: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline
Description: 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.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline
Description: 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.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline
Description: 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.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Enhanced recovery after breast surgery (ERABS) strategies
Description: 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.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Enhanced recovery after breast surgery (ERABS) strategies
Description: 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.

Intervention type: PROCEDURE
Group type: SHAM_COMPARATOR
Intervention: Sham paravertebral block using saline
Description: 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.

Intervention type: PROCEDURE
Group type: SHAM_COMPARATOR
Intervention: Sham paravertebral block using saline
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Paravertebral block using local anesthetic
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Paravertebral block using local anesthetic
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Paravertebral block using local anesthetic
Description: 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.