Recruiting

Pain Management

Sponsor:

Georgetown University

Code:

NCT04046068

Conditions

Post-operative Pain

Post-operative Nausea and Vomiting

Respiratory Depression

Confusion Postoperative

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

ComfortSafe Care

Study Details

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.

Conditions

Post-operative Pain

Post-operative Nausea and Vomiting

Respiratory Depression

Confusion Postoperative

Study ID

NCT04046068

Start date

May 11, 2020

Status verified date

Sep, 2020

Completion date

Sep, 2021

Anticipated

Primary completion date

Jul, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

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.

Primary outcome measure

  • Post-operative Pain: VAS [ Time Frame: 24 hours ]
  • Post-operative nausea and vomiting [ Time Frame: 24 hours ]
  • respiratory depression [ Time Frame: 24 hours ]
  • confusion post-operative [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Lauren Payne, RN

2024445201lp827@georgetown.edu

Peggy Compton, RN, PhD

3109801036pcompton@nursing.upenn.edu

Locations

Medstar Georgetown University Hospital

Recruiting

Washington, District of Columbia, United States, 20007

Contacts

Lauren Payne

202-444-5201lp827@georgetown.edu

More Information

Sponsor

Georgetown University

Last update posted

Oct 5, 2020

Last verified

Sep, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Georgetown University on 2020-10-05.