NGR 6803, R. S., Project Proposal

Running head: PREMEDICATION FOR NAUSEA IN CESEAREAN SECTION 1

Premedication for Nausea in Cesarean Section: Project Proposal

Samantha Rodriguez, Student Registered Nurse Anesthetist

University of South Florida

PREMEDICATION FOR NAUSEA IN CESEAREAN SECTION 2

Abstract

Cesarean section is commonly associated with complications such as nausea and vomiting in the

intraoperative and postoperative setting; however, a streamline method of preventing or reducing

the incidence of nausea and vomiting has yet to be initiated. Nausea is multifaceted, and most

evidence based research recommends pre-medicating high risk populations. However, this is not

always a common practice. According to the research, the incidence of perioperative nausea and

vomiting is best prevented with a low dose pharmacologic combination of serotonergic and

dopaminergic blocking medications. Pre-surgical assessment of the patient and their medical,

familial, and social history is key in preventing nausea in the obstetric patient. Another factor

that may decrease or prevent nausea in this patient population is collaboration between the

patient, surgeon and the anesthetist. With consideration of these aspects of care, clinicians may

best manage negative side effects and promote a positive birthing experience. Therefore, the aim

of this proposed, evidence-based practice project is to examine the effectiveness of using a

guideline for obstetrical care provided during the perioperative period to women undergoing

cesarean section. The guideline focuses on ensuring normotension of patients, while

premedicating patients who are at high risk of developing nausea, and encouraging the limitation

of intraoperative practices that cause nausea and vomiting. Data will be collected from Good

Samaritan Medical Center over an eight week time frame, and outcomes of the guideline

implemented method will be compared with previous practice standards. A detailed explanation

of the implementation of this project is described in the paragraphs to follow.


Preventing Nausea in Cesarean Section: Project Proposal.

Nausea and vomiting are some of the more common complications that occur during

cesarean section. These side effects can cause significant distress to the mother and families

involved, as well as cause difficulties during the procedure. Nausea is challenging to treat and

prevent because of the multiple etiologies and variability among individuals. Research shows

that multiple medications are effective and that surgical techniques can also minimize incidence.

Coordination between perioperative personnel and a thorough evaluation of the parturient also

appear to decrease incidence of nausea and vomiting. The purpose of this written discussion is

to propose an evidence based project at Good Samaritan Hospital, comparing current practice

outcomes with installation of a guideline for preventing nausea over an eight week duration.

Description of Problem

There are many instances of nausea and vomiting that accompany cesarean section; some

sources site as high as 80% of cases. In 2013, in the United States, just under one in three births

or 32.7% of births were via cesarean delivery (Osterman & Martin, 2014). If 80% of these

parturients experienced nausea that would amount to 1,032,857 mothers out of 1,291,071 total

cesarean sections. Osterman & Martin go on to explain that individual state trends were similar

to national trends with cesarean section (2014). As expected, births via cesarean section

worldwide are quite variable, with Liberia have less than 3.9% and the Dominican Republic

having over 56% of all births in 2013 (World Health Organization, 2015). The high incidence of

nausea with cesarean section suggest that there is a need for a change in current practice in

prevention of nausea and vomiting in this patient population.

The population affected is parturients undergoing cesarean section who experience

nausea and vomiting, these side effects present a serious risk if they occur intraoperatively. If


clinicians are able to identify which strategies are superior in this specific patient population then

they may be able to create a more streamline method for preventing nausea and consequently for

improving the labor experience. Our population of interest is women scheduled for cesarean

section at Good Samaritan Hospital for the selected eight week duration.

Other approaches have failed in the past because nausea that accompanies cesarean

section is multifaceted. Some possible causes of nausea and vomiting are hypotension, opioids

and other medications that are administered during cesarean section (Griffiths, Gyte, Paranjothy,

Brown, Broughton & Thomas, 2012). Nausea and vomiting that occur intraoperatively could

result in aspiration of gastric contents and could also jeopardize the surgical incision as a result

of movement. The many features of nausea and vomiting allow intervention to be focused at

multiple low cost strategies. For example, partnering with surgeons to minimize manipulation of

the uterus intraoperatively involves minimal expense. Also, the project will involve institution

of an evaluation tool to ensure adequate assessment of risks for perioperative nausea and

vomiting. Patients who are identified as being at risk will be premedicated with a combination

of antiemetics which have been supported by evidence to minimize nausea, create few side

effects, and are cost effective.

Review of Literature

We thoroughly assessed eight articles and found that timing and dosing methods could be

more important in preventing nausea and vomiting than the medications themselves. Multiple

medications have previously been identified as being effective in preventing nausea and

vomiting and the selected studies supported not only that fact but also that pretreatment,

multimodal treatment and lower doses of drugs are most effective at preventing nausea and

vomiting in the parturient. Therefore, the following themes of evidence were extracted and are


presented in the paragraphs below: a) pretreatment and multimodal treatment appear beneficial,

b) lower doses are just as effective, and c) minimizing surgical manipulation decreases nausea

and vomiting.

Pretreatment and Multimodal Treatment

Earlier research suggests that nausea and vomiting should not be prevented but rather

treated after the symptoms have already emerged. For example, Balki and Carvalho (2005)

believed that intraoperative maneuvers could prevent nausea and vomiting associated with

cesarean section and that after these techniques were fully employed then antiemetics could be

administered for any additional complaints. They suggest that by providing a quality regional

block, minimizing opioids and reducing surgical techniques that increase incidence of nausea

and vomiting, such as uterine exteriorization, these adverse effects could be prevented.

However, recent literature is supporting pretreatment due to relatively safe medications with few

side effects and the large incidence of nausea with cesarean section. A meta-analysis conducted

by Mishriky and Habib evaluated 702 patients who received metoclopramide for prophylaxis and

had no reported side effects from any of the patients (2012). Another study found that the

incidence of intraoperative nausea occurred as frequently as 20% to 60% of all patients

undergoing cesarean (Griffiths et al., 2013). Other studies have actually reported the incidences

as high as 80%. This evidence supports accounts that recommend prophylaxis should be utilized

as opposed to treatment of perioperative nausea and vomiting for cesarean delivery.

Chao, Evangelista, Rietzel, Artinian & Mullen (2013) looked at postoperative nausea and

vomiting in a retrospective study and found that multimodal treatment was associated with fewer

instances of postoperative nausea and vomiting (PONV) compared to monotherapy (P < .001 and

P = .018). Dominguez and Ashraf (2013) also stated that metoclopramide alone was not


effective in preventing PONV but that the combination of metoclopramide and ondansetron was

more effective than placebo (20 vs. 39%, p < 0.017). Habib and Ashraf (2013) found that,

compared to the placebo group, the multimodal group performed better at obtaining the results of

no intraoperative or PONV and no need for rescue dosing (odds ratio 3.2, 95% CI 1.7-6; P <

.001). Imeh, Olaniyi, Simeon & Omotola (2014) also supported multimodal prevention when

comparing dexamethasone and dexamethasone with ondansetron for PONV (9.3% vs 37%,

respectively, P = 0.003). Perioperative nausea and vomiting associated with cesarean section

was significantly reduced with multimodal regimens compared to single and placebo controls in

the recent research evaluated.

Lower Doses

There were no difference between four and eight milligrams of ondansetron (serotonin

receptor antagonist) for the treatment of perioperative nausea and vomiting prophylaxis

(Dominguez & Ashraf, 2013). No differences were detected between varying doses of serotonin

receptor antagonists in (Griffiths et al., 2012). Mishriky and Habib (2012) discovered that the

ten milligram dose of metoclopramide was effective at preventing nausea and vomiting

compared to previous studies that stated a larger doses were required. The results suggested that

the minimal effective dose that is recommended for the medication may be just as efficient at

preventing perioperative nausea and vomiting as larger doses.

Minimizing Manipulation

Habib et al. (2013), reinforces that exteriorization of the uterus (extra-abdominal repair of

the uterine incision at cesarean delivery) significantly increases the incidence of nausea in the

perioperative period. Karger (2003), also states that Patient movement and early ambulation in

the post anesthesia care unit (PACU) increases baseline PONV risk due to stimulation of the


vestibular nerve causing motion sickness. Minimizing surgical manipulation and patient

movement will result in decreased incidence of nausea and vomiting.

A total of eight articles were assessed for this literature review. The articles consisted of

four single research studies that were randomized controlled trials, two meta-analysis, one non-

experimental correlational design and one systematic appraisal. The John Hopkins Nursing

Evidence Based Practice (JHNEBP) appraisal tools assisted us in identifying the characteristics

of the designs so we could rate them level I to level V. The tools also enabled us to evaluate the

quality of the findings and we rated them from high quality (A), good quality (B) to low quality

or major flaws (C). Based on the appraisal of evidence our studies were rated as follows: one

VA, one IIIC, five IB and one IA. The evidence since 2012 is categorized in the good and

consistent evidence section which supports continued research prior to suggesting a change in

practice. Implementation of a pilot study and evaluation of the data will assist in determining if

these interventions will be effective at Good Samaritan Medical Center prior to changing

practice.

The results of this review suggest that current evidence supports pretreatment,

multimodal treatment, and minimizing intraoperative techniques that increase nausea

(exteriorization of the uterus, overuse of opioids and unnecessary movement of the patient). An

evidence-based translation project to answer the following PICO question is proposed: Will

pretreatment, multimodal treatment and minimizing intraoperative manipulation improve nausea

and vomiting in scheduled cesarean section patients compared to current practice?

Goals/Aims

The goals of this project are to decrease the incidence of nausea and vomiting during the

perioperative period and instill an organized method for evaluating and treating parturients who


are at risk. Doing this will ensure a more positive birthing experience for laboring women. The

inauguration of proposed methods will prospectively result in a decreased incidence of nausea

and vomiting in scheduled cesarean sections. By decreasing the incidence of nausea and

vomiting, the hospital’s satisfaction surveys will be monitored for a positive effect, in this patient

population, which will result in increased funding due to the Hospital Value-Based Funding from

Medicare.

Project Design and Conceptual Framework

The project design will be an evidence-based practice translation project and it is guided

by The JHEBP process. This framework follows three phases: answering the practice question,

evaluating the evidence and translating into practice. There are 18 steps listed under these

phases, and the framework begins with recruiting the inter-professional team located under the

practice question phase. Followed by developing and refining the question, as well as the scope

and identity of key stakeholders. These steps are followed by determining the responsibility of

the project leader. The evidence phase includes: organizing team meetings, conducting a search

for evidence, appraising the evidence, summarizing, synthesizing and developing

recommendations for change of practice. The last phase, translation, concludes with determining

the fit of the project with the setting, creating an action plan, securing resources, implementation

and evaluation. Reporting outcomes to stakeholders, identifying the next steps and

disseminating findings are also crucial steps in the translation phase.

The five steps encompassing the evidence section have already been conducted in this

project. Recruiting the team members and identifying member responsibility still need to occur,

as well as scheduling meetings and determine key stakeholders. After determining the additional


members involved and consolidating evidence, the project can move to the translation phase.

The guidelines in the translation phase are answered in the paragraphs to follow.

Implementation Plan

The project will be conducted on the labor and delivery unit at Good Samaritan Hospital

in Lafayette, Colorado. Informed consent will be obtained from all participants who meet

inclusion criteria and performance will be ethical and devoted. All patients who meet the

inclusion criteria will be monitored during the perioperative period for nausea and vomiting.

The patients will be evaluated using a risk evaluation tool for nausea and vomiting, and high risk

patients will be premedicated. Partnering with anesthesiologists, certified registered nurse

anesthetists (CRNA), nurses and surgeons will be essential. Education will be provided to these

staff members and documentation of the results will be extracted from the patient charts.

Analysis of previous data with new data after the plan is implemented, will compare reports of

nausea and documentation of emesis, as well as satisfaction survey scores. The lead investigator

will be Samantha Rodriguez, a first year student registered nurse anesthetist. She will be guided

in her work by Dr. Susan Perry¸ the director of the CRNA program at the University of South

Florida.

Setting

The labor and delivery unit at Good Samaritan Hospital has agreed to implement the

project, and administrative approvals to conduct the project at this location have been obtained.

The Institutional Review Board for Sisters of Charity Leavenworth Health Systems has approved

the project design.


Target Population

The target population includes uncomplicated, scheduled cesarean section parturients

using spinal anesthesia. Exclusion criteria are urgent or emergent cesarean sections, epidural

anesthesia, general anesthesia, systemically ill patients, multiple gestations, gestosis, patients

with allergies to the medications being used, current smokers and patients under the age of 18 or

older than 40.

Sampling Strategy

The sampling method will be convenience sampling. The total projected sample size will

include all parturients who are willing to participate during the eight week duration. This project

will compare previous documentation of nausea and vomiting on a similar sample size to

documentation after we have implemented the change.

Procedure/Intervention

This project will involve partnering with and educating physicians and nurses regarding

interventions that are supported by evidence to reduce the unpleasant symptoms of nausea and

vomiting that is so often associated with cesarean section. The education will include a review

of current research in the incidence of nausea and vomiting in this patient population, problems

that nausea and vomiting create, and current recommended practice guidelines.

The project involves, using a modified Risk Evaluation Tool that has previously been

shown to be effective in other populations. The simplified risk score is an evaluation tool that

assesses if patients have experienced nausea and vomiting previously related to anesthesia (Balki

& Carvalho, 2005). History of motion sickness, hypotension, and the use of opioids are also

predictors for nausea and vomiting. After assessing the participants, premedication will be

provided to those identified as high risk for developing nausea and vomiting. A combination of


5 mg metoclopramide and 4 mg ondansetron will be administered to the high risk population.

Patients will be medicated for complaints of nausea based on provider discretion. Patients will

receive one liter minimal parenteral fluids prior to onset of spinal anesthesia. Patients will also

be treated for hypotension based on provider discretion and opioid use should be minimized.

Intraoperatively, surgeons will be encouraged to only perform exteriorization of the

uterus when medically necessary. Moving the patient will occur once after anesthesia has been

administered. The patient will be moved from the operating table to their bed and additional

transfers will be discouraged.

These procedures will be implemented because they are consistent with current evidence.

Several studies (Habib et al., 2013; Balki & Carvalho, 2005) state that exteriorization of the

uterus significantly increases the incidence of nausea in the perioperative period. Balki &

Carvalho (2005), state that preventing hypotension and minimizing movement and opioid use are

beneficial in reducing nausea and vomiting. Lastly, Imeh, Olaniyi, Simeon & Omotola (2014)

also state that hypotension occurs frequently with spinal anesthesia and is associated with

increased nausea and vomiting. Through thorough assessment and prompt intervention, these

implemented methods should decrease the incidence of nausea and vomiting in this population.

Methods

Success of the project will be determined based on fewer occurrences of nausea and

vomiting from documentation in the patient charts. Pre and post intervention satisfaction scores

will also be compared. The number of patients that meet inclusion criteria during the eight week

time frame will be compared with the same number of patients that meet inclusion criteria prior

to installation of the interventions in a retrospective manner. Designated members of the project

team will be responsible for collecting data from the patient charts after the eight week duration.


Samantha Rodriguez, project director, will be responsible for data management and data will not

leave the Sisters of Charity Leavenworth’s, password protected, data management system.

Microsoft Access 2016 software will be utilized by the project team to organize and evaluate the

data. A hired statistician will also have access to the Microsoft Access management system.

Data will be organized based on rates of nausea and vomiting, number of antiemetics used and

satisfaction scores. This data will be accessible to team members with a password via the Sisters

of Charity Leavenworth employee website. Data will only be shared after completion of the

project and personal patient information will not be shared at any point in time. A data and

safety monitoring committee is not indicated given the nature of this project.

Analysis and Evaluation Plan

Data regarding the rates parturients experience nausea and vomiting, and number of times

patients receive antiemetics will be entered into spreadsheets. Additional data will contain the

factors included in the risk assessment questionnaire. This data will be evaluated by team

members in the form of graphs, trends, histograms and box plots. Statistical tests that will be

used are the t-test, to assist in determining if the two data sets are alike; the ANOVA which will

determine the variation between the two groups, and a statistical hypothesis test to determine if

the results are significant.

Protection of Human Subjects

The execution of this evidence based practice (EBP) project is consistent with

current research, and the variables implemented should pose no instances of harm or limitations

to prospective subjects. Informed consent will be obtained from every participant. Compliance

with HIPAA rules will be maintained throughout the assignment, although it is not necessary to

collect any identifiable patient information. An application for evaluation and approval of this


project will be submitted to the University of South Florida Institutional Review Board. The

plan will not begin until final approval has been granted. The variables create minimal risk for

participants, who may only be subject to the inconvenience associated with the request for

information and opinion. All members of the team will complete the Collaborative Institute

Training Initiative’s required and elective modules, including Research Involving Human

Subjects.

Dissemination of Results

The results of the EBP project will be disseminated first to key stakeholders during an

informal meeting at Good Samaritan Hospital, where the project will be conducted. Next, staff

members of Good Samaritan, and students and faculty of the University of South Florida’s

College of Nursing will be invited to a conference and informed of the results.

Summary

Nausea and vomiting are common problems among women who are undergoing regional

anesthesia for cesarean section. Nausea and vomiting can be distressing for families and cause

intraoperative complications. Because of the high incidence of nausea and vomiting in this

group and the low risk of side effects from antiemetics, pretreatment with antiemetics is

consistent with current research. Research also supports multimodal and small doses prior to

surgery for those that are identified as being at risk. Meticulous assessment and prompt

intervention of other factors that cause nausea, including hypotension, are also indicated.

Avoiding overuse of opioids and limiting surgical manipulation have been paramount in

decreasing documented rates of nausea and vomiting. By screening and pretreating cesarean

section patients for nausea and vomiting, and limiting intraoperative techniques shown to

increase nausea and vomiting, unpleasant side effects can be curtailed. By preventing or


decreasing nausea and vomiting during cesarean section, maternal satisfaction with the birthing

process will be improved and complications minimized.


References

Balki, M., Carvalho, J. C. A., (2005). Intraoperative nausea and vomiting during cesarean section

under regional anesthesia. International Journal of Obstetric Anesthesia, 14, 230-241.

doi:10.1016/j.ijoa.2004.12.004

Chao, Y., Evangelista L., Rietzel, K., Artinian, S., Mullen, K. (2013). Examining the predictors

of postoperative nausea and vomiting in women following cesarean delivery. Journal of

Obstetrics, Gynecological & Neonatal Nursing, 42, S84. doi:10.1111/1552-6909.12175

Dominguez, J.E., Habib, A.S. (2013). Prophylaxis and treatment of the side-effects of neuraxial

morphine analgesia following cesarean delivery. Current Opinion Anesthesiology, 26(3),

288-295. doi:10.1097 /ACO.0b013e328360b086

Griffiths, J.D., Gyte, M. L. G., Paranjothy, S., Brown, H.C., Broughton, H.K., Thomas, J. (2012).

Interventions for preventing nausea and vomiting in women undergoing regional

anesthesia for caesarean section. Cochrane Database of Systematic Reviews, (9).

doi:10 .1002/14651858.CD007579.pub2

Habib, A.S., George, R. B., Mckeen, D. M., White, W.D., Ituk, U.S., Megalla, S.A. & Allen,

T.K. (2013). Antiemetics added to phenylephrine infusion during cesarean delivery: a

randomized controlled trial. Obstetrics & Gynecology, 121(3), 615-623. doi:10.1097

/AOG.ob013e3182839fee

Imeh, A., Olaniyi, O., Simeon, O., Omotola, O. (2014). Dexamethasone versus a combination of

dexamethasone and ondansetron as prophylactic antiemetic in patients receiving


intrathecal morphine for caesarean section. African Health Sciences, 14(2), 453-459. doi:

http://dx.doi.org/10.4314/ahs.v14i2.23

Karger, B., Donnerer, J. (ed). (2003). Prevention and treatment of postoperative nausea and

vomititng. Antiemetic therapy. 121-160. doi:10.1159/000071414

Mishriky, B.M., Habib, A.S. (2012). Metoclopramide for nausea and vomiting prophylaxis

during and after caesarean delivery: a systematic review and meta-analysis. British

Journal of Anesthesia, 108(3), 374-383. doi:10.1093/bja/aer509

Osterman, M.J.K. & Martin, J.A. (2014). Trends in low-risk cesarean delivery in the United

States, 1990-2013. National Vital Statistics Reports, 63(6). Retrieved from http:

//www.cdc.gov/nchs/data/nvsr/nvsr63/nvsr63_06.pdf

World Health Organization. (2015). Global health observatory data repository: Women data by

country. Retrieved from http://apps.who.int/gho/data/node.main.REPWOMEN39 ?

lang=en

Documents

NGR 6803, R. S., Project Proposal