Enhanced Recovery Strategies in Elective Breast Surgery

Bilateral breast reduction and bilateral breast augmentation are both routine plastic surgery
procedures commonly performed on an outpatient basis. While patient satisfaction following
these procedures is high, postoperative pain management can be challenging, resulting in
decreased patient satisfaction, delayed recovery including delayed return to work and daily
activities, increased opioid pain medication requirements and occasionally unplanned hospital
admissions, surgical complications, and increased cost of care [Davis].

PVB is a common procedure used for analgesia in breast surgery in combination with multimodal
perioperative pain regimens, though its use has not been formally studied in a prospective
fashion. Our Division recently retrospectively studied the use of PVB in breast reduction,
finding that postoperative pain scores and rates of PONV were decreased with the use of PVB.
To date, no prospective, randomized, blinded study has been performed to evaluate the
efficacy of PVB on perioperative pain management in this patient population. Multiple studies
performed in patients undergoing post-mastectomy breast reconstruction have demonstrated the
safety and efficacy of PVB as an adjunctive pain control modality. In a prospective study
evaluating patients undergoing post-mastectomy autologous breast reconstruction, Parikh and
colleagues found that patients who received PVB had significant improvement in postoperative
pain, shorter time to oral-only opioid usage and decreased length of hospital stay compared
to patients who received standard postoperative pain control [Parikh]. A meta-analysis
conducted by Schnabel and colleagues studied 15 randomized controlled trials evaluating PVB
in addition to general anesthesia for patients undergoing breast surgery found significant
decrease in postoperative pain scores with low risk ratio for adverse events [Schnabel].

The concept of "enhanced recovery" or "fast track" surgery was borne out of several
prospective studies in the gastrointestinal surgery literature, and has been shown in
multiple types of operations and across specialties to be beneficial for patients as well as
economically advantageous [Anderson, Bonde, Adamina]. The concept of using an integrative,
multimodal, multidisciplinary approach for minimizing the physiologic stress response in
attempt to improve recovery after surgery was first described in 1997 [Kehlet]. Throughout
the past several years there has been increasing focus on applying such principles to breast
surgery, though to date the literature has focused on operations primarily performed for
breast cancer, including mastectomy and breast reconstruction [Arsalani, Bonde]. The goal of
"enhanced recovery after surgery" (or "ERAS") protocols is to identify and employ a set of
pre-, peri- and postoperative strategies to improve patient outcomes and the recovery process
after surgery. Such interventions have the goal of minimizing perioperative physiologic
stressors (e.g. pain, fatigue, anxiety, nausea and vomiting) that can lead to morbidity.
Categories related to "enhanced recovery after breast surgery" (ERABS) include standardized
preadmission counseling, preoperative fasting, preanesthetic anxiolytics, anesthetic
protocols, intraoperative warming, pain control, prevention of nausea and vomiting,
mobilization, and postdischarge support [Arsalani].

Thus, the overarching goal of this study is to evaluate the safety and efficacy of PVB alone,
as well as in conjunction with a global set of perioperative enhanced recovery strategies in
elective breast surgery. We hypothesize that the use of such strategies will improve the
patient experience of breast reduction and augmentation beyond the current standard of care.

We are conducting this study because, to our knowledge, no previous study has prospectively
evaluated the use of PVB (with or without additional ERAS strategies) in groups comprised
only of patients undergoing non-oncologic breast surgery. We hypothesize that the use of PVB
in breast reduction and breast augmentation may be as beneficial as it has been shown to be
in patients undergoing lumpectomy or mastectomy and subsequent reconstruction. In addition,
no other study, to our knowledge, has prospectively studied enhanced recovery strategies
(with PVB) in elective breast surgery (including reduction and augmentation). Due to the
physical and psychosocial differences in patients undergoing elective breast surgery
(compared to oncologic breast surgery), we wish to study elective breast surgery to better
understand the effects of ERABS strategies on postoperative pain, nausea, and overall patient
recovery.

There are four serial aims of this study. The overarching goal of the study is to
prospectively assess the use of PVB as an adjunct for postoperative pain control both alone
and in the setting of related ERABS strategies in elective breast surgery (both breast
reduction and breast augmentation, two of the most common non-oncologic breast operations
performed in an ambulatory setting). The methodologies used to assess postoperative pain, the
set of collective ERABS strategies, the potential risks and benefits of study participation,
and the inclusion/exclusion criteria will be the same in the groups studying breast reduction
and those studying breast augmentation. As both operations are performed on a regular basis
in the PI's practice, we feel it essential to evaluate both operations.

Following completion of all 4 groups, we will be able to assess the impact of PVB alone as
well as the impact of ERABS strategies in both breast reduction and breast augmentation. We
hope that this will help inform clinical conversations with patients and also guide clinical
decision-making with respect to postoperative pain management and overall optimization of
recovery in elective breast surgery. We feel it important that the four distinct groups be
included under the single protocol.

The primary aim in all four groups in this study is to evaluate postoperative pain scores in
patients receiving either paravertebral block or ERABS strategies compared to patients who do
not receive these interventions. Additional outcomes include use of analgesic and antiemetic
medication, development of PONV, time to discharge, patients' assessment of quality of
recovery as determined by a validated survey and overall patient satisfaction.

Group 1: To prospectively determine the effect of PVB on perioperative pain and postoperative
recovery following breast reduction. We will use patient-reported pain assessments (including
a numeric rating scale) to evaluate our primary endpoint (pain scores on postoperative day 1
(POD1)) as well as additional outcome measures of pain scores in recovery and at 1 week
post-surgery. To determine the effect of PVB on secondary endpoints of this study, we will
calculate analgesic and antiemetic medication use, compare average time (minutes) spent in
the PACU, average time (minutes) spent in Phase 2, total time (minutes) between the end of
the operation and discharge to home, and evaluate the occurrence of unplanned hospital
admission, PONV, overall satisfaction, patients' assessment of quality of recovery as
determined by a validated survey [Gornall, Myles], and complications. This data will be
obtained through review of medical records, surveys, and postoperative diaries.

Patients electing to undergo breast reduction will be invited to participate in the study at
their preoperative visit. All patients choosing to take part in the study will be consented
prior to their procedure. The study participants will be randomized to one of two arms within
each Group using block randomization. Details of the allocated group will be written on a
piece of paper and placed inside sealed, opaque, and sequentially numbered, envelopes. Block
randomization will be performed using a computer-generated number list and an Excel
spreadsheet template. Block randomization will ensure equal numbers of subjects in each
group. Either the anesthesiologist or the surgical team will open the envelope when the
patient presents to UW Transformations Surgery Center the day of surgery. The subject will be
randomized to receive either (a) standard postoperative nausea and pain control as well as a
sham superficial injection of normal saline or (b) PVB in addition to standard postoperative
nausea and pain control. PVB and sham superficial injections of normal saline will be
performed by a trained anesthesiology provider and will be performed in the routine manner.
Surgery will take place in the usual fashion and participants will receive standard of care
for pain and nausea control.

Following surgery, patients will be assessed for postoperative pain, nausea and vomiting.
Assessment for postoperative pain will consist of a validated pain score survey administered
prior to transfer to phase II postoperatively, on POD1, and at their one-week postoperative
visit. Participants will also be asked to record, using a postoperative diary/log, when they
take postoperative analgesics and antiemetics, which medications are taken, and quantity of
medication taken. This will also be reviewed both in the medical record and upon discussion
with the participant at the postoperative visits. Assessment of the time spent in the
recovery room, time spent in Phase 2 of recovery, and time to discharge from the hospital
(total time between the end of surgery to discharge from hospital), will be obtained via
review of the medical record. At the first postoperative visit, participants will undergo a
routine interview that includes discussion of their pain control, analgesic and antiemetic
use, recovery process, and overall satisfaction. The medical record will be reviewed for any
unplanned postoperative hospital readmissions related to the surgery.

Group 2: To prospectively determine the effect of PVB on perioperative pain and postoperative
recovery following breast augmentation. We will use patient-reported pain assessments
(including a numeric rating scale) to evaluate our primary endpoint (pain scores on
postoperative day 1 (POD1)) as well as additional outcome measures of pain scores in recovery
and at 1 week post-surgery. To determine the effect of PVB on secondary endpoints of this
study, we will calculate analgesic and antiemetic medication use, compare average time
(minutes) spent in the PACU, average time (minutes) spent in Phase 2, total time (minutes)
between the end of the operation and discharge to home, and evaluate the occurrence of
unplanned hospital admission, PONV, overall satisfaction, patients' assessment of quality of
recovery as determined by a validated survey, and complications. This data will be obtained
through review of medical records, surveys, and postoperative diaries.

The procedures will be the same as those described for Group 1, except patients will be
undergoing planned breast augmentation.

Groups 3 and 4: To prospectively compare the standard of care for ambulatory breast surgery
to "fast track" (also known as "enhanced recovery") strategies for breast surgery by
assessing pain scores, pain medication and antiemetic use, development of nausea/vomiting,
time to discharge, and patient satisfaction.

For the third serial Group in the study, patients electing to undergo breast reduction
surgery will be invited to participate in the study at their preoperative visit. For the
fourth Group in the study, all procedures will be the same as described in this section, but
the patients will be undergoing breast augmentation surgery (not breast reduction). All
patients choosing to take part in the study will be consented prior to their procedure. The
study participants will be randomized, using block randomization, a computer-generated
randomization template, and sealed, numbered, and opaque envelopes, to either receive (a)
perioperative pain, nausea, and recovery strategies as part of our Enhanced Recovery after
Breast Surgery (ERABS) protocol, or (b) perioperative instructions, anesthesia and
medications as per our institution's current standard of care for elective breast reduction
or breast augmentation.

We will use validated pain assessments to evaluate our primary endpoint (pain scores on
postoperative day 1 (POD1)) as well as additional outcome measures of pain scores in recovery
and at 1 week post-surgery. To determine the effect of PVB on secondary endpoints of this
study, we will calculate analgesic and antiemetic medication use, compare average time
(minutes) spent in the PACU, average time (minutes) spent in Phase 2, total time (minutes)
between the end of the operation and discharge to home, and evaluate the occurrence of
unplanned hospital admission, occurrence of PONV, assessment of recovery, overall
satisfaction, and complications. This data will be obtained through review of medical
records, questionnaires, and postoperative diaries.

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.

- 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 and thus would not be
undergoing surgery at Transformations. This would include women with
sepsis/bacteremia, significant valvular disorders or heart conditions.