Clinical trial NCT03187080: Enhanced Recovery Strategies in Elective Breast Surgery
Official title: Evaluating the Use of Enhanced Recovery Strategies and Paravertebral Block in Elective Breast Reduction and Breast Augmentation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain, Acute
Nausea
Vomiting, Postoperative
Opioid Use
Satisfaction
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 113
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: There are four serial aims of this study. The overarching goal 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.
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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. To date, no prospective, randomized, blinded study has been performed to evaluate the efficacy of PVB on perioperative pain management in this patient population.

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. The investigators hypothesize that the use of such strategies will improve the patient experience of breast reduction and augmentation beyond the current standard of care.

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.

Following completion of all 4 groups, the investigators 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.

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. Patient-reported pain assessments (including a numeric rating scale) will be used to evaluate the 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, analgesic and antiemetic medication use will be calculated, average time (minutes) spent in the Post Anesthesia Care Unit (PACU), average time (minutes) spent in Phase 2, and total time (minutes) between the end of the operation and discharge to home will be compared, the occurrence of unplanned hospital admission will be evaluated, PONV assessed, overall satisfaction, patients' assessment of quality of recovery as determined by a validated survey, and complications documented. 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 or Madison Surgery Center (MSC) 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. Patient-reported pain assessments (including a numeric rating scale) will be used to evaluate the 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, analgesic and antiemetic medication use will be calculated, average time (minutes) spent in the PACU, average time (minutes) spent in Phase 2, and total time (minutes) between the end of the operation and discharge to home will be compared, the occurrence of unplanned hospital admission will be evaluated, PONV assessed, overall satisfaction, patients' assessment of quality of recovery as determined by a validated survey, and complications will be documented. 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.

Validated pain assessments will be used to evaluate the 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, analgesic and antiemetic medication use will be calculated, average time (minutes) spent in the PACU, average time (minutes) spent in Phase 2, and total time (minutes) between the end of the operation and discharge to home will be compared, and the occurrence of unplanned hospital admission will be evaluated, occurrence of PONV assessed, assessment of recovery, overall satisfaction, and complications documented. This data will be obtained through review of medical records, questionnaires, and postoperative diaries.

Eligibility criteria: 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 or Madison Surgery Center (MSC).
* 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 or MSC and thus would not be undergoing surgery at Transformations or MSC. This would include women with sepsis/bacteremia, significant valvular disorders or heart conditions.

Primary outcomes:
measure: Numerical Pain Scores, Rated by Patient on 0-10 Scale
timeFrame: Postoperative day 1
Secondary outcomes:
measure: Numerical Pain Scores, Rated by Patient on 0-10 Scale
timeFrame: Day of surgery
measure: Time Spent in Each Phase of Care Prior to Discharge
timeFrame: Day of surgery
measure: Time to Discharge to Home
timeFrame: Day of surgery
measure: Analgesic Requirements Reported as the Number of Participants Who Were Still Taking Medications Post-Operatively Day 7
timeFrame: 1 week after surgery
measure: Post-operative Nausea and Vomiting (Subjective Report) Measured as the Mean Incidence Reported Post-Operatively Day 7
timeFrame: 1 week after surgery
measure: Anti-emetic Requirements Measured as Number of Participants Taking Anti-nausea Medication Post-Operatively Day 7
timeFrame: 1 week after surgery
measure: Patients' Assessment of Perceived Quality of Recovery Using Modified Quality of Recovery Survey (MQOR-40)
timeFrame: 1 week after surgery
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Venkat K Rao, MD, MBA
role: PRINCIPAL_INVESTIGATOR
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