Multimodal Perioperative Pain Management: ComfortSafe Program

NCT ID: NCT04046068

Last Updated: 2020-10-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-11
• Study Completion Date: 2021-09-30

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.

Conditions

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: collaborator

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medstar Georgetown University Hospital

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

Site Status: RECRUITING

Countries

United States

Central Contacts

Lauren Payne, RN

Role: CONTACT

lp827@georgetown.edu

2024445201

Peggy Compton, RN, PhD

Role: CONTACT

pcompton@nursing.upenn.edu

3109801036

Facility Contacts

Lauren Payne

Role: primary

lp827@georgetown.edu

202-444-5201

Other Identifiers

2018-0854

Identifier Type: -

Identifier Source: org_study_id