Status:
UNKNOWN
Multimodal Perioperative Pain Management: ComfortSafe Program
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
University of Pennsylvania
Conditions:
Post-operative Pain
Post-operative Nausea and Vomiting
Eligibility:
All Genders
21-75 years
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 abdo...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 11 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04046068
Start Date
May 11 2020
End Date
September 1 2021
Last Update
October 5 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007