Post-operative PainNCT04046068
Multimodal Perioperative Pain Management: ComfortSafe Program
An observational study of Post-operative Pain and Post-operative Nausea and Vomiting, run by Georgetown University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Post-operative Pain, Post-operative Nausea and Vomiting, Respiratory Depression
- What is being tested?
- ComfortSafe Care
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2020to Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Be between the ages of 21 and 75 years of age.
- Be eligible to receive bupivacaine liposomal injectable suspension.
- Be undergoing a planned inpatient surgical (breast, caesarian-section or abdominal) procedure with general anesthesia.
- Provide an opioid-free urine prior to surgical procedure.
- Have a supportive, significant other willing to facilitate patient adherence to ComfortSafe program
- Be agreeable to study procedures and capable of signing an informed consent.
Who cannot join
- Be on chronic opioid therapy for chronic pain or treatment of opioid use disorder.
- Have chronic pain.
- Have an active substance use disorder on alcohol, benzodiazepine, methamphetamine, cocaine or other drugs of abuse (except nicotine).
- Be acutely psychotic, severely depressed and in need of inpatient treatment, or an immediate suicide risk.
- Have a neurological or psychiatric illness (i.e., schizophrenia, quadriplegia, stroke) that would affect pain responses.
- Be undergoing a surgical procedure for which liposomal bupivacaine cannot be used (eg. Skin graft, wound debridement, ureteroscopy, hysteroscopy, eye surgery).
- Have a diagnosis of Obstructive Sleep Apnea with use of CPAP
- Have an ASA score of 2 or greater as determined by the anesthesiologist.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Lauren Payne, 202-444-5201, lp827@georgetown.edu
About this study
Official title: Improving Patient Outcomes Using Multimodal Perioperative Pain Management: The ComfortSafe Program
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.
Read the 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
- Being tested
- ComfortSafe Care
- Medical subject headings
- Pain, Postoperative, Vomiting, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ComfortSafe CareProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
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.
Measured: 24 hours
respiratory depression
Respiratory depression will be scored as present (respiratory rate ≤ 10 breaths/minute) or absent (respiratory rate > 10 breaths/minute)
Measured: 24 hours
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.
Measured: 24 hours
Secondary outcomes (2)
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.
Measured: 1 month, 3 months and 6 months
Chronic Post-surgical opioid consumption
Patients will be discharged with an analgesic use diary and daily MME will be calculated.
Measured: 1 month, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start11 May 2020
- Primary completionJul 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046068
- Sponsor's protocol ID
- 2018-0854
- Status last verified
- Sep 2020
- First submitted
- 17 Jul 2019
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Patient Outcomes Using Multimodal Perioperative Pain Management: The ComfortSafe Program
- ClinicalTrials.gov ID
- NCT04046068
- Acronym / sponsor ID
- 2018-0854
- Conditions
- Post-operative Pain, Post-operative Nausea and Vomiting, Respiratory Depression, Confusion Postoperative
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- 11 May 2020 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 6 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Be between the ages of 21 and 75 years of age.
- Be eligible to receive bupivacaine liposomal injectable suspension.
- Be undergoing a planned inpatient surgical (breast, caesarian-section or abdominal) procedure with general anesthesia.
- Provide an opioid-free urine prior to surgical procedure.
- Have a supportive, significant other willing to facilitate patient adherence to ComfortSafe program
Key exclusion criteria (8 listed)
- Be on chronic opioid therapy for chronic pain or treatment of opioid use disorder.
- Have chronic pain.
- Have an active substance use disorder on alcohol, benzodiazepine, methamphetamine, cocaine or other drugs of abuse (except nicotine).
- Be acutely psychotic, severely depressed and in need of inpatient treatment, or an immediate suicide risk.
- Have a neurological or psychiatric illness (i.e., schizophrenia, quadriplegia, stroke) that would affect pain responses.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ComfortSafe CareIn 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. | Procedure or surgery | – |
Primary outcome
Post-operative Pain: VAS
Time frame: 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
Time frame: 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
Time frame: 24 hours
Respiratory depression will be scored as present (respiratory rate ≤ 10 breaths/minute) or absent (respiratory rate > 10 breaths/minute)
confusion post-operative
Time frame: 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.
2 secondary outcomes
Chronic Post-surgical Pain
Time frame: 1 month, 3 months and 6 months
Chronic Post-surgical opioid consumption
Time frame: 1 month, 3 months and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-operative Pain and Post-operative Nausea and Vomiting, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lauren Payne, RN (2024445201, lp827@georgetown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative Pain: VAS (time frame: 24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.