Running Head: MULTIMODAL VS.

OPIOID ONLY PAIN MANAGEMENT 1

Research Proposal: Can the use of Multimodal Vs. Opioid Only Pain Management

Reduce Pain, and Improve Outcomes in Enhanced Recovery After Surgery (ERAS)

Surgical Patients?

Jean A. O’Connor

NUR 560 Nursing Research

SUNY Polytechnic Institute

December 11, 2017

MULTIMODAL VS. OPIOID ONLY PAIN MANAGEMENT 2

Abstract

Opioids are traditionally used to manage acute and chronic pain in healthcare settings.

Opioid side effects, and risk of addiction has called for alternative methods to pain

management. Multimodal pain management is one way to reduce the use of opioids.

Enhanced Recovery After Surgery (ERAS) is a surgical approach that can reduce opioid

use through multimodal pain management. In this qualitative, quasi-experimental study

of 100 men and women undergoing gastrointestinal, gynecological, or orthopedic surgery

in a single clinical research site, participants will be enrolled in ERAS or non-ERAS

surgical groups and will be followed for 6 months postoperatively. Multivariate analysis

of variance will be used to evaluate pain management in ERAS vs. non-ERAS surgical

patients, and outcome data including: complications, days to discharge, and readmission

rates. Results of this study will determine if multimodal pain management in ERAS

surgical patients reduce pain, and improve outcomes compared to current standards of

surgical care in non-ERAS surgical patients.

MULTIMODAL VS. OPIOID ONLY PAIN MANAGEMENT 3

Managing acute pain in the post-operative period is one of the goals during phase

I recovery in the post anesthesia care unit (PACU), (Polomano, Dunwoody, Krenzischek,

& Rathmell, 2008), and opioids have long been the gold standard of how that pain is

managed (Gupta & Gan, 2015). Opioid use continues throughout the recovery phase on

the surgical unit, and after discharge. Pain management has typically been singular in

approach, with opioids such as Fentanyl, Hydromorphone, Morphine, and Oxycodone as

the primary opioids of choice. However, opioid use presents with certain risks to patients

including nausea, vomiting, respiratory depression, lethargy, reduced mobility,

constipation, urinary retention, and addiction risk, which can affect both patient

outcomes, and health care costs (Tabler, 2016; Gupta & Gan, 2016). With the rise in our

nations opioid epidemic, there has been a mobilization to decrease opioid use in both the

acute and chronic pain patients (Murthy, 2016; Mason, 2016).

Multimodal pain management is gaining traction as an alternative to singular

opioid use during the perioperative and post-operative period, and falls under the

guidelines of Enhanced Recovery After Surgery (ERAS) protocols for major abdominal,

gastrointestinal (GI), gynecological (GYN), Orthopedic, Bariatric, and Urologic surgeries

(ERAS Society, 2016). The practice of ERAS originally developed in Europe out of a

desire to fast track major abdominal surgeries, and to reduce the length of stay through a

multimodal approach to recovery (Ljungqvist, Young-Fadok, & Demartines, 2017). The

ERAS society was founded in 2010 as an international, nonprofit, medical, academic

society focused on fluid surgical protocols guided by evidence-based practice in

perioperative care that utilizes a multimodal approach to surgery (Ljungqvist, 2014).

Understanding the effectiveness of multimodal pain management vs. singular opioid use
MULTIMODAL VS. OPIOID ONLY PAIN MANAGEMENT 4

in reducing pain, and improving outcomes in ERAS surgical patients will help to guide

how to successfully manage surgical pain, and potentially reduce outpatient opioid use.

Statement of the Problem

Opioid addiction in the United States has reached a critical level (Murthy, 2016).

There is a long history of opioid use in relation to pain management for both acute and

chronic pain (Tompkins, Hobelmann & Compton, 2016). The push by pharmaceutical

companies to prescribe opioids, the Joint Commissions oversight of pain assessment,

treatment, and reassessment based on the 0-10 numeric pain scale, and the need to

appease pain related HCAHPS and patient satisfaction scores created by the Centers for

Medicare and Medicaid Services (CMS) tied to hospital reimbursements, has contributed

to the overuse of opioids for chronic and acute pain management (Mason, 2016;

Tompkins, Hobelmann, & Compton, 2016; Van Zee, 2009). Effective alternative

approaches to pain management are necessary to help reduce long-term opioid use.

Multimodal pain management is one option that can be used on ERAS surgical patients

that challenges the singular opioid approach to pain management throughout the

perioperative, post-operative, and discharge periods.

In the Post Anesthesia Care Unit (PACU) patients are traditionally managed

utilizing a singular approach to pain management with the use of opioids during Phase I

of recovery (Polomano, Dunwoody, Krenzischek, & Rathmell, 2008). Unfortunately

opioid use has spread beyond acute surgical management. ERAS is a relatively new way

of managing surgical patients in the United States, and ERAS protocols are guided by a

multimodal approach to pain management, reducing opioid use throughout the entire

perioperative, post-operative, and discharge periods. The purpose of this research is to

MULTIMODAL VS. OPIOID ONLY PAIN MANAGEMENT 5

determine if multimodal pain management is as effective as opioid alone pain

management in reducing pain, and improving outcomes in ERAS surgical patients.

Review of Relevant Literature

In 1992 the Agency for Health Care Policy and Research (AHCPR) established

clinical guidelines which set pain management goals to include reducing pain,

complications, length of hospital stay, patient education on communicating pain, and

increasing patient satisfaction (Good, 1998). The goal of ERAS is to reduce metabolic

stress, accelerate recovery, and minimize hospital stay through the use of multimodal

pain management, fluid homeostasis, reduction of complications, and early mobilization

(Ljungqvist, 2014).

Current literature is demonstrating the positive effects of multimodal pain

management for surgical management of patients (Lamplot, Wagner, Manning, 2014;

Devin, McGirt, 2015, Kang et. al., 2013; Murato-Ooiwa, Tsukada & Wakui, 2017),

however these are not ERAS surgical cases. The ERAS protocols for gynecologic

oncology, and gastrointestinal surgery elaborate on the management of pain through

multimodal technique, but emphasize that the current literature regarding multimodal

pain management is not related to ERAS cases (Nelson et al., 2016; Feldheiser et al.,

2016). Very little data is available comparing multimodal pain management of ERAS

surgical cases to non-ERAS surgical cases (Kehlet & Holte, 2001). One retrospective

urology study demonstrated a positive result with multimodal pain management

compared to opioids in ERAS patients (Xu et. al., 2015), Non-opioid pain management in

the form of multimodal pain management and in conjunction with ERAS protocols
MULTIMODAL VS. OPIOID ONLY PAIN MANAGEMENT 6

warrant further education and implementation (White, 2017; Stone et. al., 2017; Wardhan

& Chelly, 2017), especially in light of the current opioid crisis.

If multimodal pain management can be as effective, if not more effective, than

opioid use alone, then we may see improved patient outcomes, and an overall reduction

in opioid use in the ERAS surgical patient population. However further research, such as

proposed in this study will be necessary to specifically identify the effects of multimodal

pain management as it relates to ERAS surgical cases, and compared to non-ERAS

surgical cases to establish a more cogent relationship between the two.

Theoretical Framework

Metabolic stress reduction is one of the major goals guiding the ERAS protocols.

Metabolic stress creates a catabolic state with the development of insulin resistance, and

multiple metabolic postoperative complications (Ljungqvist, 2014; Kehlet & Holte,

2001)). Pain causes the release of the two major stress hormones cortisol and

catecholamine leading to insulin resistance. Pain management therefore is a priority in

ERAS protocols. ERAS protocols seek to reduce pain, and control metabolic stress

through a multimodal approach to pain management (Ljungqvist, 2014).

Good and Moore’s middle-range theory of acute pain management evolved from

the AHCPR guidelines, and align themselves with the ERAS principles of balancing

analgesia and side effects through propositions and interventions that focus on

multimodal pain management, attentive pain management, and patient participation

(Good, 1998). According to Good (1998), “From this theory, testable hypotheses

regarding pain management can be deduced, and new findings can be used to support and

extend the theory.” Good and Moore’s theory reads analogous to the founding principles
MULTIMODAL VS. OPIOID ONLY PAIN MANAGEMENT 7

of the ERAS protocols inspired by the early work of Professor Henrik Kehlet M.D.

(Carli, 2014; ERAS Society, 2016). This study aligns itself with Good and Moor’s theory

of acute pain management as it seeks to determine if multimodal pain management can be

effective in managing pain, and improving outcomes in ERAS surgical patients vs. non-

ERAS surgical patients.

Definition of Terms

Conceptual and operational terms and definitions used in this study include:

1. Multimodal pain management-A synergistic combination of regional anesthesia,

and analgesia including: non-steroidal anti-inflammatory drugs (NSAIDS),

Acetaminophen, Gabapentin, Pregabalin, Tramadol, Oxycodone,

Hydromorphone, Dexamethasone, and intravenous Lidocaine.

2. Opioid pain management-Narcotic analgesics used post-operatively that may

include Fentanyl, Hydromorphone, Morphine, and Oxycodone.

3. ERAS-Enhanced Recovery After Surgery. A multimodal approach to surgery that

seeks to improve patient outcomes, and reduce length of stay with the utilization

of multimodal pain management, fluid homeostasis, early mobilization, and

decreased complications.

4. Numeric Pain scale-A scale ranging from 0-10 to determine a patient’s pain level.

5. Patient satisfaction scores/HCAHPs-Hospital Consumer Assessment of

Healthcare Providers and Systems, a patient satisfactory survey developed by the

Centers for Medicare and Medicaid Services (CMS), and required by all hospitals

to distribute to adult inpatients.

6. Outcomes-Dependent variables used for this study including nausea, vomiting,

MULTIMODAL VS. OPIOID ONLY PAIN MANAGEMENT 8

constipation, urinary retention, bleeding, PE, days to discharge, and readmission

rates.

Methods and Procedures

This study is seeking to determine if the use of multimodal pain management vs.

opioid only pain management can reduce pain and improve outcomes in ERAS surgical

patients. Data collection for this study will look at both ERAS and non-ERAS patient

reported pain levels, and outcomes that comprise of days to discharge, readmission rates,

and complications including nausea, vomiting, constipation, urinary retention, bleeding,

and pulmonary embolus (PE). Data will be collected from one site through detailed data

collection questionnaires, and medical record review. Follow up will be continued on the

data collection questionnaire, and HCAHPS questionnaire through telephone interviews.

Internal site medical record review will be used to identify patients that qualify

for this study. ERAS and non-ERAS patients will be flagged for study participation by

their prospective surgeon. Patients will be given preoperative teaching on both ERAS and

non-ERAS approaches to their prospective surgical procedures and will chose the course

based on informed surgical consent. Patients will then follow the preoperative surgical

management for ERAS or non-ERAS surgical procedures.

On the day of surgery patients will be admitted to the Ambulatory Surgery Area

(ASC) where the Data Collection Questionnaire will be initiated. ERAS cases receiving

preoperative nerve blocks will be transferred to the PACU per standard protocol, and the

Data Collection Questionnaire will be handed off from the ASC nurse to the PACU

nurse. Anesthesia will manage the preoperative nerve block, and intraoperative

anesthesia, and pain management choices per either the ERAS or non-ERAS protocols.
MULTIMODAL VS. OPIOID ONLY PAIN MANAGEMENT 9

Surgeons will perform prospective surgical procedures per their surgical expertise.

Operating room (OR) nurses will receive the Data Collection Questionnaire on handoff

from the ASC, or PACU nurse, and will document all necessary intraoperative data.

At anesthesia end time, the patient will be transferred to the PACU for phase I

recovery. The Data Collection Questionnaire will be handed off from the OR nurse to the

PACU nurse. At the completion of phase I the patient will be transferred to the

postoperative surgical unit, and the Data Collection Questionnaire will be handed off

from the PACU nurse to the surgical floor nurse. Upon patient discharge the Research

nurse will collect all the Data Collection Questionnaires, and will continue to document

data at the 1,3, and 6-month follow-up phone call visits.

After discharge the patient will receive the self administered, mailed survey,

HCAHPS questionnaire, which will be collected to review the pain management section

questions. If the patient does not complete the HCAHPS form, this data will be collected

at the 1-month follow-up phone visit. This data collects closed-ended questions, which

has the benefits of easy administration and analysis due to number tabulation of the

responses (Polit & Beck, 2018).

Follow up phone call questionnaires will be determined by an interview schedule

at 1 month, 3 month and 6 months. Interview data are advantageous because they tend to

have higher response rates than mailed questionnaires, provide more information, and

tend to lack ambiguity (Polit & Beck, 2018). The importance of patient participation in

the postoperative surveys and interviews will need to be reinforced at the time of

discharge.
MULTIMODAL VS. OPIOID ONLY PAIN MANAGEMENT 10

Research Design

This research proposal design is a long term, qualitative, quasi-experimental

design looking to determine if multimodal pain management is as effective as single

opioid pain management in reducing pain and improving outcomes in ERAS vs. non-

ERAS surgical patients. Pain management will be evaluated based on the pain numeric

rating scale, and the HCAHPS pain management questions. Outcomes are defined as days

to discharge, readmission rates, and complications such as nausea, vomiting,

constipation, urinary retention, bleeding, and PE. Prospectively study participants will be

site specific and meet the surgical criteria for ERAS for GI, GYN, and Orthopedic cases,

and will be compared to non-ERAS identical surgical procedure patients.

Setting

This will be a single clinical site setting located in a community hospital. Patients

will be evaluated for eligibility during the office surgical consultation, and then followed

throughout the perioperative and postoperative period that includes: the ambulatory

surgery area, the operating room, the PACU, and the surgical unit. Follow up will be over

the phone, and not require visits unless complications require further evaluation.

Sampling

This long term, qualitative, quasi-experimental study will be using consecutive

sampling for the total population sample that meet the eligibility criteria. Sample size will

include 100 men and women to be enrolled in GI, GYN, or orthopedic ERAS protocols

vs. current standards of non-ERAS surgical care protocols. Prospective sampling will

occur from one single site and include all ERAS surgical cases and identical non-ERAS

surgical cases. Prospective study participants will be site specific and meet the surgical
MULTIMODAL VS. OPIOID ONLY PAIN MANAGEMENT 11

criteria for ERAS for GI, GYN, and Orthopedic cases, and or standard of care non-ERAS

surgical cases. Eligibility criteria include medical clearance for surgery, and the ability to

follow nutritional directions. Informed consent will be obtained.

Ethical Considerations

This study consists of human subjects and two treatment modalities. Qualification

criteria for ERAS patients include the ability to follow preoperative nutritional directions,

or be assisted by someone who can. Those unable to follow directions may present a bias

for research staff. Ethical considerations include the protection of study participant’s

privacy through HIPPA, and adherence to the nurse’s code of ethics as it relates to

research (Epstein & Turner, 2015). Pain is a very personal, and subjective feeling, and

patients who experience perceived pain during their recovery, and regardless of which

protocol they may be enrolled in, may feel they are not sufficiently being relieved of their

pain, and may feel they were not fully informed of the risks. This could lead to distrust,

and withdrawal from the study. Institutional IRB approval will be obtained, and patient

informed consent will be collected.

Measurement Instruments

Internal site medical record data will be collected including patient reported pain

using the numeric pain scale, and the HCAHPS self administered, mailed survey

questionnaire. Follow up phone call data collection will be determined by an interview

schedule at 1, 3, and 6 months, where data will be collected on hospital readmission, and

postoperative complications. The numeric pain scale will assess pain management at each

interval.

The numeric pain scale rating 0-10 is a valid and reliable tool to assess
MULTIMODAL VS. OPIOID ONLY PAIN MANAGEMENT 12

postoperative pain (Williamson, & Hoggart, 2005). This tool will be used frequently

throughout the study to determine pain levels and response to pain management. The

HCAHPS form is a nationally, standardized, publically reported, health care quality

measure tool devised by the Centers for Medicare & Medicaid Services, and the Agency

for Healthcare Research and Quality (AHRQ), and endorsed by the National Quality

Forum that measures patients’ perspectives on health care (CMS.gov, 2014). Only the

HCAHPS section on pain will be collected for this study.

Data Collection

Data will be collected in a systematic fashion and will be formatted into a

standardized questionnaire that covers the preoperative, intraoperative, postoperative,

surgical unit, and follow-up phases of the protocol. The data collection questionnaire

will cover the following categories, however, analysis data will focus on the independent

and dependent variables. All patients will be required to sign an informed consent to

participate in this study. Patient confidentiality will be maintained under HIPPA All data

to be collected can be found in the following two charts.

MULTIMODAL VS. OPIOID ONLY PAIN MANAGEMENT 13

Preoperative Intraoperative Postoperative

Management Management Management
Study Category: ERAS or NON- Intubated: Yes or No PAR Score on Arrival
ERAS
Name Anesthesia Type PAR Score at Discharge
DOB General Numeric Pain Scale on Arrival
Medical Record Number Spinal Numeric Pain Scale on
Discharge
Gender Epidural Complications Phase I:
Airway
Hemodynamics
Nausea
Vomiting
Bleeding
Chest Pain
Shortness of Breath
Urinary Retention
Diagnosis IV Lidocaine Postoperative Pain
Management: drug, dose,
route, time

Surgical Procedure Narcotics Numeric Pain Scale for Every

Pain Medication Intervention
Medical History Other Intraoperative Medication Postoperative IV Fluids

Surgical History IV Fluids Postoperative Vital Signs

Allergies
Home Medications
Preoperative Oral Fluid Intake
Amount
Time of Last Oral Intake
Preoperative Vital Signs
Preoperative Numeric Pain Scale
EBL Foley: Yes or No
Foley: Yes or No Foley Removed in PACU Yes
or No
Urine Output Ambulated in PACU: Yes or
No
Duration of Surgery
Complication Intraoperative:
Airway, Hemodynamics,
Vomiting, Bleeding.

Preoperative Pain Management

Preoperative Nerve Block: Type

and Location

Complications Preoperatively:
Hemodynamic
Block Side Effects
MULTIMODAL VS. OPIOID ONLY PAIN MANAGEMENT 14

Surgical Unit Follow-up Phone Call Management

Management 1, 3, and 6 months
Date Date
Postoperative Day (POD): 1,2,3,4,5,6,7 Numeric Pain Scale
Circle POD, and Complete for Each POD
patient is admitted
IV Fluids HCAHPS Questionnaire
Foley: Yes or No List of all Medications: drug, dose, route
Postoperative Pain Management: drug, List of Pain Medications: drug, dose, route
dose route, time
Numeric Pain Scale for Every Pain Readmission to Hospital:
Medication Intervention Date
Reason
Complications Surgical Unit: Complications Home:
Nausea Nausea
Vomiting Vomiting
Hemodynamics Bleeding
Bleeding Chest Pain
Chest Pain Shortness of Breath
Shortness of Breath S/S DVT
Signs/Symptoms DVT Constipation
Constipation Urinary Retention
Urinary Retention
Time and Date of Each Ambulation
Time and Date of Discharge
Numeric Pain Scale Upon Discharge
Discharge Prescriptions: drug, dose, route,
schedule, PRN. Include over the counter
medication not requiring a prescription
covered in the discharge instructions.

Analysis

Multivariate analysis of variance (MANOVA) will be used to analyze study data.

Multivariate analysis is used for complex relationships among variables (Polit & Beck,

2018). MANOVA will compare the two groups, those that are ERAS surgical patients,

and those that are not ERAS surgical patients (the independent variables). MANOVA

will determine several dependent variables, the first being the effectiveness of

multimodal pain management on ERAS surgical patients as compared to opioid only pain
MULTIMODAL VS. OPIOID ONLY PAIN MANAGEMENT 15

management on non-ERAS patients. Outcomes data including complications such as

nausea, vomiting, constipation, urinary retention, bleeding, PE, as well as time to

discharge and readmission rates will also be evaluated in both groups.

Limitations

This study is not without its limitations. Pain is an individual, subjective human

experience. Personal beliefs on pain, and pain management may bias patient’s decision to

participate as an ERAS patient in this protocol. Healthcare providers are not without bias

towards what they are used to in terms of standards for pain management. Healthcare

workers lack knowledge in the area of acute pain management and have been accused of

both under medicating pain Polomano et.al., 2008), or over prescribing for pain (VanZee,

2009). As ERAS is a relatively new way of managing a patient’s surgical experience,

healthcare workers knowledge may be lacking in this area, and therefore bias towards

change from what is known, to what is new may exist (Ljungqvist, 2014). Therefore

adequate patient teaching, and professional education programs should be established in

advance.

Dissemination of Findings

Research on multimodal pain management compared to singular opioid pain

management for ERAS surgical cases is lacking (Nelson et. al., 2016). This study will be

useful in determining the effectiveness of multimodal pain management on ERAS

surgical cases, and the data should be presented to those specialties that could benefit the

most from this information. However, if multimodal pain management proves to be

effective over singular opioid use, then all disciplines that prescribe pain management for

acute pain could potentially benefit from these results as well. The main target audience
MULTIMODAL VS. OPIOID ONLY PAIN MANAGEMENT 16

for this study includes: perioperative and surgical nurses, anesthesiologists, surgeons, and

surgical patients. The results of this study should be presented in a peer-reviewed journal

in the areas of perioperative nursing, anesthesia, and surgical journals specific to

gastroenterology, gynecology, and orthopedics. Journal articles allow for higher

dissemination of information, from a trusted scientific source, and afford credibility to the

work being published. Options for peer-reviewed journals to incorporate the results of

this study into their publications include but are not limited to: The Journal of

PeriAnesthesia Nursing, The Journal of Anesthesia and Clinical Research,

Gastroenterology Nursing, Journal of Gastrointestinal Surgery, Journal of Gynecologic

Oncology Nursing, Gynecologic Oncology Journal, Orthopedic Nursing Journal, Journal

of Orthopedic Surgery and Research.

Discussion

Managing postoperative pain is critical to reducing metabolic stress in

postoperative patients. Pain that is well controlled postoperatively leads to improved

outcomes, and reduces costs related to prolonged hospital stay. Opioids have been the

gold standard for pain management, but are not without side effects. Opioid addiction

has garnered attention in the United States due to the over prescribing, and misuse of

opioids. Multimodal pain management is an alternative to singular opioid use in the

management of pain in surgical patients. ERAS is relatively new way of managing

surgical patients that includes the use of multimodal pain management to improve patient

outcomes. This protocol seeks to determine if the use of multimodal pain management vs.

singular opioid pain management will reduce pain and improve outcomes in ERAS

surgical patients compared to the current standard of surgical care.

MULTIMODAL VS. OPIOID ONLY PAIN MANAGEMENT 17

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