Clinical trial NCT04046068: Multimodal Perioperative Pain Management: ComfortSafe Program
Official title: Improving Patient Outcomes Using Multimodal Perioperative Pain Management: The ComfortSafe Program
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post-operative Pain
Post-operative Nausea and Vomiting
Respiratory Depression
Confusion Postoperative
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
First posted: 2019-08-06
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Post-operative Pain: VAS
timeFrame: 24 hours
measure: Post-operative nausea and vomiting
timeFrame: 24 hours
measure: respiratory depression
timeFrame: 24 hours
measure: confusion post-operative
timeFrame: 24 hours
Secondary outcomes:
measure: Chronic Post-surgical Pain
timeFrame: 1 month, 3 months and 6 months
measure: Chronic Post-surgical opioid consumption
timeFrame: 1 month, 3 months and 6 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Medstar Georgetown University Hospital
state: District of Columbia
Study officials:
References: