Multimodal Perioperative Pain Management: ComfortSafe Program

Improving Patient Outcomes Using Multimodal Perioperative Pain Management: The ComfortSafe Program

Proposed is a demonstration project to characterize the immediate, short-term and long-term pain and other post-operative outcomes of 60, self-selected breast (n=20), caesarian-section (n=20) and abdominal (n=20) surgical patients who receive opioid-sparing, multimodal anesthesia and pain management care as guided by the ComfortSafe Pyramid.

Study Overview

• Status: Unknown
• Conditions: Post-operative Pain; Respiratory Depression; Post-operative Nausea and Vomiting; Confusion Postoperative
• Intervention / Treatment: Procedure: ComfortSafe Care

Detailed Description

In well-characterized samples of patients undergoing breast, caesarian-section or abdominal surgery, the efficacy and safety of perioperative pain care organized by ComfortSafe Pyramid approaches will be evaluated. In addition, patient satisfaction with this care will be evaluated. Post-operative pain and opioid-related outcomes will be operationalized using standardized symptom (nausea, vomiting, respiratory depression, confusion, acute and chronic pain) severity measures, prn analgesic (opioid and non-opioid) consumption, and urine toxicology. Together, these original data will have important implications for the clinical management of post-operative pain utilizing opioid-sparing and multi-modal approaches.

A total of 60 self-selected surgical patients will be enrolled in the study, 20 undergoing breast surgery, 20 undergoing caesarian-section, and 20 undergoing abdominal surgery. All will receive anesthesia and pain management consistent with the ComfortSafe Pyramid which emphasizes opioid-sparing and multimodal approaches. Side and adverse opioid-related effects and post-operative pain will be assessed at regular intervals during the immediate post-operative period (24 hours). To evaluate the incidence of opioid misuse/abuse and the development of chronic pain, an opioid use history, urine toxicology and Brief Pain Inventory will be collected at 1 month, 3 months and 6 months following discharge. Patient satisfaction measures will be obtained at discharge, 1 month, and 3 months follow-up timepoint.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Lauren Payne, RN; Phone Number: 2024445201; Email: lp827@georgetown.edu
• Study Contact Backup: Name: Peggy Compton, RN, PhD; Phone Number: 3109801036; Email: pcompton@nursing.upenn.edu

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Recruiting
      • MedStar Georgetown University Hospital
      • Contact: Lauren Payne; Phone Number: 202-444-5201; Email: lp827@georgetown.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients preparing to undergo surgery will be recruited from the Pre-Anesthesia Testing (PAT) unit in the Department of Anesthesiology at Medstar Georgetown University Hospital (MGUH). The staff nurse practitioner will inform all patients scheduled for caesarian-section or abdominal surgery of the ComfortSafe program, and provide them a patient education brochure for their review. If a patient is interested in participating in the program, he or she will be instructed to contact the study research nurse to learn more about participation and consider enrolling. Subjects will therefore be self-selected and enrolled on a rolling, convenience basis.

Description

Inclusion Criteria:

1. Be between the ages of 21 and 75 years of age.
2. Be eligible to receive bupivacaine liposomal injectable suspension.
3. Be undergoing a planned inpatient surgical (breast, caesarian-section or abdominal) procedure with general anesthesia.
4. Provide an opioid-free urine prior to surgical procedure.
5. Have a supportive, significant other willing to facilitate patient adherence to ComfortSafe program
6. Be agreeable to study procedures and capable of signing an informed consent.

Exclusion Criteria:

1. Be on chronic opioid therapy for chronic pain or treatment of opioid use disorder.
2. Have chronic pain.
3. Have an active substance use disorder on alcohol, benzodiazepine, methamphetamine, cocaine or other drugs of abuse (except nicotine).
4. Be acutely psychotic, severely depressed and in need of inpatient treatment, or an immediate suicide risk.
5. Have a neurological or psychiatric illness (i.e., schizophrenia, quadriplegia, stroke) that would affect pain responses.
6. Be undergoing a surgical procedure for which liposomal bupivacaine cannot be used (eg. Skin graft, wound debridement, ureteroscopy, hysteroscopy, eye surgery).
7. Have a diagnosis of Obstructive Sleep Apnea with use of CPAP
8. Have an ASA score of 2 or greater as determined by the anesthesiologist.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative Pain: VAS	Severity of post-operative pain will be operationalized as both (1) responses on a visual analogue pain scale (VAS) and (2) consumption of analgesic medications. The VAS ranges from 0 (no pain) to 10 (worst pain imaginable). Dose and type of analgesic medications consumed during the first 24 hours postoperatively will be abstracted from the electronic record and total amount of each entered into the study database. Opioids administered will be converted into morphine equivalent doses (MED) for analysis.	24 hours
Post-operative nausea and vomiting	The incidence and severity of post-operative nausea and vomiting experienced by the subjects will be measured at each time point using Postoperative Nausea and Vomiting (PONV) impact scale. This tool records the frequency, intensity and duration of nausea, as well as the number of vomits, and designed to detect minimal clinically important differences. Specifically, the tool uses ordinal responses to quantify nausea intensity and impact on the patient, where (i)=0, (ii)=1, (iii)=2, and (iv)=3. In addition, the number of vomits are used to quantify vomiting intensity, scored as the number of vomits (0-2, or 3 if three or more vomits); both scores are added together to obtain the simplified PONV impact scale score. When anitemetics are used, their dose and timing will be recorded.	24 hours
respiratory depression	Respiratory depression will be scored as present (respiratory rate ≤ 10 breaths/minute) or absent (respiratory rate > 10 breaths/minute)	24 hours
confusion post-operative	Post-operative confusion will be assessed with the Delirium Observation Screening (DOS) scale, a 13-item scale developed to facilitate early recognition of delirium according to Diagnostic and Statistical Manual-IV criteria. Evaluated on a 4pt Likert scale (0-never, 4-always) are, consciousness; attention; thinking; memory; psychomotor activity; sleep/wake; mood; and perception, with items totaled to provide an overall delirium score. The scale boasts good internal consistency, and content, predictive, concurrent and construct validity in adult and elderly populations.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic Post-surgical Pain	To capture the presence and severity of ongoing pain, the Brief Pain Inventory (BPI) will be administered. This tool goes beyond measurement of the intensity of pain (sensory dimension), to evaluate interference by pain in the patient's life (reactive dimension), as well as pain relief, pain quality, and the patient's perception of the cause of pain. With respect to functionality, the BPI asks for ratings of the degree to which pain interferes with mood, walking and other physical activity, work, social activity, relations with others, and sleep; using numeric 0 to 10 scales, with 0 being "no interference" and 10 being "interferes completely," the mean of these scores is used as a pain interference score. For analysis, the pain worst rating can be chosen to be the primary response variable, with the other items serving as a check on variability, or, alternatively, the ratings can be combined to give a composite index of pain severity.	1 month, 3 months and 6 months
Chronic Post-surgical opioid consumption	Patients will be discharged with an analgesic use diary and daily MME will be calculated.	1 month, 3 months and 6 months

Collaborators and Investigators

• Sponsor: Georgetown University
• Collaborators: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 11, 2020
• Primary Completion (ANTICIPATED): July 1, 2021
• Study Completion (ANTICIPATED): September 1, 2021

Study Registration Dates

• First Submitted: July 17, 2019
• First Submitted That Met QC Criteria: August 2, 2019
• First Posted (ACTUAL): August 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 5, 2020
• Last Update Submitted That Met QC Criteria: September 30, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Postoperative Complications; Pain; Neurologic Manifestations; Neurobehavioral Manifestations; Signs and Symptoms, Digestive; Nausea; Pain, Postoperative; Vomiting; Respiratory Insufficiency; Postoperative Nausea and Vomiting; Confusion
• Other Study ID Numbers: 2018-0854

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No