Reduction in Postoperative Nausea and Vomiting (PONV) Leads to Decrease in Emesis, Length of Stay, and Opioid Use in Bariatric Surgery Patients

General Information

Institution Name: Bon Secours St. Francis Hospital

Primary Author & Title: Ginny Ledbetter, MSN, APRN, ACNS-BC, CBN, Bariatrics Program Manager and MBS Coordinator

Co-Authors & Titles: Kaitlin O’Brien, DNP, RN, Bariatric & Metabolic Surgical Clinical Reviewer; Hilliary Goode, BS, MSN, CRNA, Lead CRNA, Bariatric & Metabolic Surgery; Patrick D. Walker, PharmD, BCCCP, Pharmacy Clinical Specialist; Alison Partridge, PhD, RN, CPAN, Research Nurse Scientist, RSFH Nursing Excellence Department; Charles K. Mitchell, Jr., MD, FACS, FASMBS, Medical Director, Bariatric Surgery and Medical Weight Loss; Bryan K. Thomas, MD, Bariatric Surgeon

Name of the Case Study: Reduction in Postoperative Nausea and Vomiting (PONV) Leads to Decrease in Emesis, Length of Stay, and Opioid Use in Bariatric Surgery Patients

Problem Detailing

Bariatric surgery is inherently associated with an increased risk of postoperative nausea and vomiting (PONV) compared to other surgical disciplines. In bariatric surgery patients, PONV is cited as one of the most common causes for prolonged lengths of stay (LOS) and unplanned readmissions.¹ A recent position statement published by the American Society for Bariatric Surgery states that “there is an urgent need for more research to address the significant problem of PONV in this special population.”² In their position statement, a lack of bariatric-specific screening, established management guidelines and appropriate measurement tools are among the greatest needs.² This highlights the need for more research.

After our involvement with the ENERGY Project in 2017, and with the implementation of our ERAS protocol, locally, our program observed significant improvement in LOS and drastically decreased use of opioids both in the inpatient and outpatient setting. As we continued to follow our quality data, we noted a rise in the incidence of PONV within our bariatric surgery patients. Bariatric patients were experiencing more of these occurrences than the rest of our surgical population.

A further review of our 2020 data demonstrated a higher rate of PONV and documented emesis in our bariatric patients. Our patients were having more PONV in the Post-Anesthesia Care Unit (PACU) and on the inpatient nursing unit (SPCU) than other surgery patients.

The goal of this project is to work toward improving the patient experience and decrease PONV and LOS in the bariatric surgery patient in the PACU and on SPCU.

Bon Secours St. Francis Hospital is one of four hospitals in the Roper St. Francis Healthcare system in Charleston, South Carolina. It is licensed for 190 beds and was the Lowcountry’s first Magnet Hospital. The hospital was designated in 2010 and redesignated in 2015 and 2020. The hospital specializes in neurosurgery, bariatrics, maternity care, and cancer care. Bon Secours St. Francis Hospital is a leader in image-guided, minimally invasive surgeries and was the first hospital in South Carolina to obtain CyberKnife® and O-arm™. Some of Bon Secours St. Francis Hospital’s awards include four stars for overall hospital performance by Centers for Medicare & Medicaid Services; Grade-A rating from Leapfrog; Blue Distinction Center for Maternity Care, Bariatric Surgery, and Spine Surgery; Healthgrades Critical Care Excellence Award (2018-2020); and Healthgrades recognition as one of America’s 100 Best Hospitals for General Surgery Award and America’s 100 Best Hospitals for Stroke Care Award (2020).

Goal Specification

SMART Goal

Specific: The goal of this project is to decrease PONV in the bariatric surgery patient, both within the PACU and in the SPCU, by December of 2021.

Measurable: Our data was extracted from a combination of the electronic medical record (EMR) and the MBSAQIP database.

Achievable: We have the necessary staff to implement this project.

Relevant: Eliminating nausea and vomiting should increase patient satisfaction. Decreasing LOS and readmissions is a cost savings for both patients and the hospital.

Timeline: January 26 through December 31, 2021.

Strategic Planning

Our project team leveraged a Plan-Do-Check-Act (PDCA) methodology.

Plan: We identified a subgroup of key stakeholders from the Metabolic & Bariatric Surgery (MBS) Committee members and developed a team to evaluate baseline PONV data, review literature, identify opportunities for improvement, and make recommendations for change in our current process. Our team consisted of:

• One General and Bariatric Surgeon, Chief, Department of Surgery, Bon Secours Francis Hospital, Medical Director, Roper St. Francis Bariatric Surgery and Metabolic Weight Loss Division
• One Bariatric Surgeon, Bon Secours Francis Hospital
• One Lead CRNA, Bariatric and Metabolic Surgery Bon Secours Francis Hospital
• One Bariatric Coordinator, Bon Secours Francis Hospital
• One Pharmacy Clinical Specialist, Bon Secours Francis Hospital
• One Quality Specialist and MBSCR Bon Secours Francis Hospital
• One Quality Specialist, Research Nurse Scientist RSFH Department of Nursing Excellence

In addition to our project team, we have an interdisciplinary MBS Committee that meets monthly.

The MBS Committee consists of two bariatric surgeons, two obesity medicine physicians, four advanced practice providers, one program coordinator, five dietitians, four representatives from the Quality Department, four representatives from hospital administration, five anesthesia providers, one pharmacist, and one clinical psychologist. The committee also includes representatives from Endoscopy, Imaging, Physical Therapy, Respiratory Therapy, Infusion Center, Physician Office, the preoperative area, PACU, and the inpatient nursing unit; two representatives from the OR; and four Clinical Educators.

Do: The CRNA reviewed all charts for patients undergoing bariatric surgery from October to December 2020 who had PONV in PACU and on SPCU. The presence of PONV was determined by chart review of rescue antiemetics received (ondansetron or promethazine).

A literature review was also completed.

The Fourth Consensus Guidelines for Management of PONV, published by the American Society of Enhanced Recovery (ASER) and Society of Ambulatory Anesthesia (SAMBA), highlights the importance of a multimodal approach.³ Several therapies with various mechanisms of action are cited but there is a significant lack of evidence highlighting the single best approach.⁴ Fosaprepitant and aprepitant are Neurokinin 1 (NK1) receptor antagonists and carry a Category

A Level 1 recommendation for PONV prophylaxis.³ The decision to trial fosaprepitant over alternative antiemetics with similar quality of evidence stemmed from NK1 receptor antagonists’ proven ability to reduce acute and delayed emesis. In a prospective, double-bind placebo-controlled study of 125 patients undergoing bariatric surgery with Apfel scores ≥2, utilization of aprepitant was associated with an absolute risk reduction in incidence of vomiting of 11.9%.⁵

In a retrospective chart review of 338 female patients undergoing bariatric surgery, aprepitant was associated with a cumulative reduction in vomiting episodes at 48 hours (p=0.04).6 In a retrospective database analysis of 4 identically designed, double-blind, randomized controlled studies of 171 female patients with Apfel scores ≥2, use of fosaprepitant demonstrated statistically significant reductions in vomiting episodes at 0-2 hours (p=0.002), 0-24 hours (p<0.001), and 0-48 hours (p<0.001) after surgery.6 The ASER/SAMBA guidelines suggest “NK1 receptor antagonists may be useful when postoperative emesis is highly undesirable, such as in gastric surgery.”⁷

The literature review indicated that bariatric surgical patients are high risk for PONV, as several variables comprise this risk category, including surgical site, mechanical manipulation of stomach, length of surgery, female predominance, and preoperative smoking cessation requirement.^8,9

Process Evaluation

Anesthesia proposed the addition of fosaprepitant to our established ERAS PONV prophylaxis protocol. This consisted of preoperative application of a scopolamine patch, IV dexamethasone 8 mg prior to induction of anesthesia, and IV ondansetron 4 mg within 30 minutes of emergence. After literature review and discussion with pharmacy leadership, fosaprepitant use for bariatric cases was implemented January 2021 with plans for formal review and approval by the Pharmacy and Therapeutics (P&T) committee after a three-month trial period. The PONV subgroup met biweekly to review data in preparation for P&T committee meeting on April 6, 2021, where key stakeholders were granted formal approval to continue utilization of fosaprepitant. It was added to the preoperative medication order set and was given to all bariatric surgery patients. On December 7, 2021, fosaprepitant was brought back to the P&T committee as a follow-up item to review six months of internal data since its implementation as part of the Bariatric Surgery ERAS protocol.

The team’s data gathering approach included:

• We created an Excel spreadsheet for data Metrics included postoperative nausea in PACU and/or SPCU, documented emesis, and drinking within 8 hours of surgery.
• We developed an encounter form to interview each patient. Starting on postoperative day (POD) one, a PACU nurse would evaluate the patient’s PACU experience via interview. On POD two, an anesthesia provider would perform a follow-up interview to assess for any painful or noxious stimuli throughout the perioperative
• Additional follow-up interviews were performed by phone, typically 24 to 48 hours after discharge, to assess patient’s oral intake
• All data collected was maintained in an Excel spreadsheet and updated Members of the PONV project team developed a handout highlighting key components within our

ERAS protocol and in-services were provided in May 2021 to the Ambulatory Surgery Unit (ASU), PACU and SPCU staff on the overall goals and Performance Improvement (PI) initiatives.

Several changes were made throughout the project period that could influence outcomes. Effective June 1, 2021, utilization of a preoperative scopolamine patch was discontinued. This decision stemmed from concerns that scopolamine’s anticholinergic effects could pose as a barrier to early ambulation, thus contributing more risk than benefit in light of fosaprepitant’s implementation.

Additional changes included utilization of an 8 mg dose of ondansetron in the OR, rather than 4 mg. In the early stages of data collection, our team noted that several patients were receiving an additional 4 mg dose in the PACU. We thus decided to optimize our initial ondansetron dose and provide a different drug class in the PACU as a rescue antiemetic. Other changes effective June 1, 2021 included implementation of QueaseEASE aromatherapy in PACU and SPCU, and adjustment of our goal time for postoperative ambulation and oral fluid intake from 8 hours to 6 hours.

Nurses documented the time that patients left PACU on the SPCU whiteboard as a visual cue to optimize achievement of time-dependent goals. We worked with pharmacy to develop a bariatric-specific ANES Phase 1 order set for the PACU. It provided guidance for first and second-line treatment of postoperative pain to decrease opioid use and treatment of postoperative nausea. Components included ketorolac 15mg IV for pain management, as well as QueaseEASE, promethazine 6.25mg IV, and lorazepam 0.5mg IV for nausea management.

Outcome Evaluation

Check: PONV was measured utilizing the documented administration of a rescue antiemetic in PACU or on the inpatient unit in the electronic medical record (EMR). Emesis was measured based on documented emesis volume or emesis occurrences in the EMR. Percentage was calculated based on the number of patients that received a rescue antiemetic or had emesis documented divided by the overall bariatric surgical cases each month multiplied by one hundred.

PONV data was reviewed at the monthly MBS Committee meetings. With the implementation of these process changes, we observed a decrease in PONV in our patient population from an average of 45% in 2020 to an average of 24% in 2021, and a decrease in documented emesis from an average of 16% in 2020 to an average of 4% in 2021.

One surgeon scheduled post-op ondansetron on SPCU instead of on an as-needed basis, which affected the data. As of December 2021, both surgeons prescribe scheduled post-op ondansetron and only promethazine is considered a rescue medication.

The addition of fosaprepitant and other interventions described has positively contributed to improved patient outcomes.

Act: We continue to review monthly PONV data at the MBS committee meetings in 2022 and assess for opportunities for improvement. We share data with the units, posting results and showing the success of our interventions.

Setbacks

One anesthesiologist was resistant to our strategy to minimize opioids and continued to pursue their use in our cases. All providers are tracked on an Excel spreadsheet. It was decided to exclude this provider from our analysis. Two physicians prescribed promethazine as PRN. We will perform further analysis to determine which orders were given PRN and given to treat breakthrough.

Throughout this PI project, reeducation was performed to address noncompliance with our PONV protocol. One PACU nurse was providing aromatherapy and administering IV rescue antiemetics concomitantly. Some staff members also did not retrieve preoperative orders which prompted repeat education.

There was a delay to updating the order sets in our EMR. This potentially served as a barrier since our order sets were not reflective of our PONV protocol when we began our intervention. To prevent a delay in our go-live, we provided education to the PACU nurses and Anesthesia on the protocol. This allowed us to begin implementation before the official order set was established in the system.

Gold standard assessment of postoperative pain or nausea relies on direct patient communication.³ Assessing pain and nausea can be challenging due to its subjective nature as well as the varying degrees of sedation seen in the perioperative period. In review of our baseline data, most patients reported high scores on pain and nausea scales, which prompted us to evaluate our process. However, the reliability of this data does serve as a limitation.

The timing of our PONV PI project and the implementation of the da Vinci robotic cases could have also served as a limitation, as this procedure can be associated with increased nausea, vomiting, intraoperative time, and anesthesia requirements. Utilization of da Vinci technology for robotic-assisted surgery began a couple of months prior, in January. We found that patients did not experience increased vomiting so, in spite of the longer cases and the implementation of robotic surgery, we did not see a change in our data.

We cannot be confident fosaprepitant caused the change or if it was one of the other variables implemented during our project. We also implemented the use of aromatherapy June 2021. In review, it would have been better if our project was organized differently, with consistent gaps in between each intervention.

Cost Evaluation

With an average cost of an RSFH general acute care inpatient day at $880, by cutting our length of stay (LOS) from 2 days down to 1 day, there was a potential cost savings in 2021 (332 patients) of $292,160 (calculated based on a cost of $880 per patient). While we did not reduce our LOS down to our goal of 1 day, we did reduce LOS from 2020 to 2021. Using the same volume of patients from 2020 to 2021 (332) with actual LOS data, our potential cost savings from 2020 to 2021 is as follows:

• Total potential cost savings from 2020 to 2021: $111,020.80
  • Potential cost savings for RNY cases: $20,451.20
  • Potential cost savings for sleeve cases: $90,569.60

The annual medication cost of implementation of fosaprepitant is approximately $15,000. In selecting a NK-1 receptor antagonist for the Bariatric PONV prophylaxis protocol, the parenteral prodrug

formulation, fosaprepitant, was chosen over the active oral formulation, aprepitant, to avoid potential cost constraints that would be incurred directly by the patient and optimize adherence. Since administration recommendations for PONV prophylaxis is 3 hours prior to induction, aprepitant would require patient to purchase as an outpatient and self-administer prior to presenting to the facility for their procedure.

The additional costs associated with PONV were up to one hundred times more expensive compared with prophylaxis with generic antiemetic. The cost of treating vomiting was three times more than the cost of treating nausea.

There was no additional funding for this project.

Knowledge Acquisition

Lessons learned from this project include:

• It is beneficial to have a committed team. For example, the Anesthesia team was very involved; they spoke with patients and physically went to the PACU and talked to the One of our team members previously worked in the PACU; that was helpful as she knew many of the staff. We worked directly with a PharmD, who was integral to the success of this project, a key stakeholder and part of the committee.
• It is important to have a consistent care team. In addition to the anesthesia team and PACU nurses, we had core set of floor nurses that were taking care of the bariatric While we did not experience any issues on this project, we did address it early on to make sure the project was being implemented across the board in the same way.

• Always look at your data, as this is important for continuous improvement. If you find an issue, you could dig further to determine the cause, for example, did an anesthesia provider go off protocol? Is it a one off or a trend?

Our project is unique. Our team is already involved in bariatric patient care and available, so we did not need to pull outside of our resources. Our stakeholders are engaged; the monthly interdisciplinary meetings are well attended. We share our data, and the committee provides feedback to help tweak our process. It is always encouraging when you are trying to make a change and you have interest and support for that change.

End-of-Project Decision-Making

We are still adjusting our process, and we recently added a postoperative preventative pain medication which might influence the data.

We are currently reviewing our process, taking out steps, and simplifying the data we collect while ensuring we are still on track.

We plan to share our results with other service lines. We have educated indirectly by word of mouth, and this has helped others with an interest in implementation in their programs. We will continue to monitor and review our data on a monthly basis and look for opportunities for improvement.

References

1. Berger ER, Huffman KM, Fraker T, et al. (2018). Prevalence and Risk Factors for Bariatric Surgery Readmissions: Findings From 130,007 Admissions in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program. Ann Surg, 267(1), 122–131.

2. Schumann R, Ziemann-Gimmel P, Sultana A, et al. (2021). Postoperative Nausea and vomiting in bariatric surgery: a position statement endorsed by the ASMBS and the ISPCOP. Surg Obes Rel Dis, 17(11), 1829-1833.
3. Gan TJ, Belani KG, Bergese S, et al. (2020). Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting. Anesth Analg, 131(2), 411–448.
4. Naeem, Z, Chen, IL, Pryor, AD, et al. (2020). Antiemetic prophylaxis and anesthetic approaches to reduce postoperative nausea and vomiting in bariatric surgery patients: a systematic review. Obes Surg, 30(8), 3188-3200.
5. Sinha AC, Singh PM, Williams NW, et al. (2014). Aprepitant’s prophylactic efficacy in decreasing postoperative nausea and vomiting in morbidly obese patients undergoing bariatric surgery. Obes Surg, 24(2), 225–231.
6. Therneau IW, Martin EE, Sprung J, et al. (2018). The Role of Aprepitant in Prevention of Postoperative Nausea and Vomiting After Bariatric Surgery. Obes Surg, 28(1), 37–43.
7. Murakami C, Kakuta N, Kume K, et al. (2017). A Comparison of Fosaprepitant and Ondansetron for Preventing Postoperative Nausea and Vomiting in Moderate to High Risk Patients: A Retrospective Database Analysis. BioMed Research International, 2017, 5703528.
8. Apfel CC, Kranke P, & Eberhart LH. (2004). Comparison of surgical site and patient’s history with a simplified risk score for the prediction of postoperative nausea and vomiting. Anaesthesia, 59(11), 1078–1082. https://doi.org/10.1111/j.1365- 2004.03875.x
9. Koivuranta M, Läärä E, Snåre L, & Alahuhta, (1997). A survey of postoperative nausea and vomiting. Anaesthesia, 52(5), 443–449.