Multimodal Perioperative Pain Management: ComfortSafe Program

NCT04046068 | Unknown

• 1 other identifier: 2018-0854
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-operative Pain; Post-operative Nausea and Vomiting; Respiratory Depression; Confusion Postoperative

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Chronic Post-surgical Pain

  1 month, 3 months and 6 months

• Chronic Post-surgical opioid consumption

  1 month, 3 months and 6 months

Interventions

ComfortSafe Care PROCEDURE

In most cases, sevoflurane, an inhalation anesthetic, will be used in higher-than-traditional concentrations to replace opioids and provide safe control of vital signs along with amnesia and analgesia. Intravenous (IV) propofol, esmolol, and other beta-blockers can also be administered to prevent increases in BP and HR during surgery. At the time of wound closure, the ComfortSafe Pyramid derived Preemergence Analgesic Checklist guides the anesthesia and surgical teams through collaborative decisions for implementation of a multimodal analgesic plan. Local anesthetics, including liposomal bupivacaine, can then be injected and IV non-opioid analgesics administered allowing the patient to awaken comfortably from anesthesia. Standardized kits for liposomal bupivacaine administration will be utilized. If the patient does have pain, IV opioids can be administered to provide immediate relief without hesitation since the non-opioid analgesics have already been given.

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Georgetown University: lead
• University of Pennsylvania: collaborator

Study Sites (1)

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Vomiting; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Signs and Symptoms, Digestive; Respiration Disorders; Respiratory Tract Diseases

Central Study Contacts

Lauren Payne, RN

CONTACT

2024445201; lp827@georgetown.edu

Peggy Compton, RN, PhD

CONTACT

3109801036; pcompton@nursing.upenn.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: August 6, 2019
• Study Start: May 11, 2020
• Primary Completion: July 1, 2021
• Study Completion: September 1, 2021
• Last Updated: October 5, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)