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Multimodal Perioperative Pain Management: ComfortSafe Program

NCT04046068 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2020-10-05

No results posted yet for this study

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

Interventions

PROCEDURE

ComfortSafe Care

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.

Sponsors & Collaborators

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-11
Primary Completion
2021-07-31
Completion
2021-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04046068 on ClinicalTrials.gov