Multimodal Perioperative Pain Management: ComfortSafe Program

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

• Registration Number: NCT04046068
• Lead Sponsor: Georgetown University

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.

Study Timeline

• Study First Submitted: 2019-07-17
• Study First Submitted QC: 2019-08-02
• Study First Posted: 2019-08-06
• Study Start: 2020-05-11
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-30
• Last Update Posted: 2020-10-05
• Primary Completion: 2021-07
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-operative Pain: VAS	24 hours	Severity of post-operative pain will be operationalized as both (1) responses on a visual analogue pain scale (VAS) and (2) consumption of analgesic medications. The VAS ranges from 0 (no pain) to 10 (worst pain imaginable). Dose and type of analgesic medications consumed during the first 24 hours postoperatively will be abstracted from the electronic record and total amount of each entered into the study database. Opioids administered will be converted into morphine equivalent doses (MED) for analysis.
Post-operative nausea and vomiting	24 hours	The incidence and severity of post-operative nausea and vomiting experienced by the subjects will be measured at each time point using Postoperative Nausea and Vomiting (PONV) impact scale. This tool records the frequency, intensity and duration of nausea, as well as the number of vomits, and designed to detect minimal clinically important differences. Specifically, the tool uses ordinal responses to quantify nausea intensity and impact on the patient, where (i)=0, (ii)=1, (iii)=2, and (iv)=3. In addition, the number of vomits are used to quantify vomiting intensity, scored as the number of vomits (0-2, or 3 if three or more vomits); both scores are added together to obtain the simplified PONV impact scale score. When anitemetics are used, their dose and timing will be recorded.
respiratory depression	24 hours	Respiratory depression will be scored as present (respiratory rate ≤ 10 breaths/minute) or absent (respiratory rate \> 10 breaths/minute)
confusion post-operative	24 hours	Post-operative confusion will be assessed with the Delirium Observation Screening (DOS) scale, a 13-item scale developed to facilitate early recognition of delirium according to Diagnostic and Statistical Manual-IV criteria. Evaluated on a 4pt Likert scale (0-never, 4-always) are, consciousness; attention; thinking; memory; psychomotor activity; sleep/wake; mood; and perception, with items totaled to provide an overall delirium score. The scale boasts good internal consistency, and content, predictive, concurrent and construct validity in adult and elderly populations.

Secondary Outcome Measures

Name	Time	Method
Chronic Post-surgical Pain	1 month, 3 months and 6 months	To capture the presence and severity of ongoing pain, the Brief Pain Inventory (BPI) will be administered. This tool goes beyond measurement of the intensity of pain (sensory dimension), to evaluate interference by pain in the patient's life (reactive dimension), as well as pain relief, pain quality, and the patient's perception of the cause of pain. With respect to functionality, the BPI asks for ratings of the degree to which pain interferes with mood, walking and other physical activity, work, social activity, relations with others, and sleep; using numeric 0 to 10 scales, with 0 being "no interference" and 10 being "interferes completely," the mean of these scores is used as a pain interference score. For analysis, the pain worst rating can be chosen to be the primary response variable, with the other items serving as a check on variability, or, alternatively, the ratings can be combined to give a composite index of pain severity.
Chronic Post-surgical opioid consumption	1 month, 3 months and 6 months	Patients will be discharged with an analgesic use diary and daily MME will be calculated.

Trial Locations

Locations (1)

Medstar Georgetown University Hospital; 🇺🇸 Washington, District of Columbia, United States