Post-operative Pain Clinical Trial
Official title:
Improving Patient Outcomes Using Multimodal Perioperative Pain Management: The ComfortSafe Program
NCT number | NCT04046068 |
Other study ID # | 2018-0854 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 11, 2020 |
Est. completion date | September 2021 |
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | September 2021 |
Est. primary completion date | July 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 75 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Medstar Georgetown University Hospital | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Georgetown University | University of Pennsylvania |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post-operative Pain: VAS | 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. | 24 hours | |
Primary | Post-operative nausea and vomiting | 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. | 24 hours | |
Primary | respiratory depression | Respiratory depression will be scored as present (respiratory rate = 10 breaths/minute) or absent (respiratory rate > 10 breaths/minute) | 24 hours | |
Primary | confusion post-operative | 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. | 24 hours | |
Secondary | Chronic Post-surgical Pain | 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. | 1 month, 3 months and 6 months | |
Secondary | Chronic Post-surgical opioid consumption | Patients will be discharged with an analgesic use diary and daily MME will be calculated. | 1 month, 3 months and 6 months |
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