Multimodal Perioperative Pain Management: ComfortSafe Program

Status unconfirmed

Conditions studied: Post-operative Pain, Post-operative Nausea and Vomiting, Respiratory Depression, Confusion Postoperative

In brief

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.

Key facts

Study ID

NCT04046068

Run by

Georgetown University

People needed

60

Starts

2020-05-11

Expected to finish

2021-09-01

Last updated by the study team

2020-10-05

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Medstar Georgetown University Hospital — Washington D.C., District of Columbia, United States (enrolling)

Full record on ClinicalTrials.gov

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