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Use of Patient-Controlled Analgesia in Acute Pancreatitis (PCA-AP)

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ClinicalTrials.gov Identifier: NCT04816877
Recruitment Status : Recruiting
First Posted : March 25, 2021
Last Update Posted : July 21, 2022
Sponsor:
Information provided by (Responsible Party):
Sunil Sheth, Beth Israel Deaconess Medical Center

Brief Summary:
Acute pancreatitis (AP) represents a critical health concern nationwide, with estimated 274,000 admissions annually and at a cost of 2.6 billion dollars. Current treatment strategies for AP are limited to supportive care with fluid resuscitation, analgesia, nutrition and prevention of end organ damage. Abdominal pain is often the predominant symptom in patients with AP and is treated with analgesics. As there is currently no disease-specific medical treatment to change the natural history of pancreatitis, pain control remains central to the treatment of AP. Among the analgesics, opioids have been shown to be provide safe and effective pain control in patients with AP. Current literature shows that there is no difference in the risk of pancreatitis complications or clinically serious adverse events between opioids and other analgesia options. Among hospitalized AP patients, adequate pain control often requires the use of intravenous (IV) opiates in the first 24-48 hours, which can later be transitioned to oral (PO) opioids. While there are various methods of delivering opioid medications such as IV, PO, and transdermal to name a few, IV opioids are commonly administered, either on a scheduled and/or on an as needed (PRN) basis as directed by the attending physician. In contrast to the conventional, method of physician directed IV opioid delivery, patient-controlled analgesia (PCA) is a form of IV opioid medication delivery in which the patient can rapidly titrate the opioid dose to manage variable levels of pain. This modality of opioid administration is often preferred by patients and has been widely used in postsurgical and obstetric patients to effectively treat their pain. PCA allows for faster intervention on pain limiting time to treatment and peak pain levels and has also been shown to decrease total opioid dose. However, there is limited evidence in published literature assessing the feasibility of using PCA to treat the pain of AP or comparing its efficacy and safety profile compared to the more traditional physician directed analgesia. One retrospective study has shown that use of PCA was surprisingly associated with longer hospital stays and higher rates of outpatient opioid use when compared to routine physician-directed analgesia (PDA), however there are no prospective trials to study this comparison. Hence, in this study, the investigators will compare the effects of using PCA among patients with AP to that of conventional PDA.

Condition or disease Intervention/treatment
Acute Pancreatitis Drug: Opioid

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Study Type : Observational
Estimated Enrollment : 174 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Use Of Patient Controlled Analgesia For Treating The Pain Of Acute Pancreatitis: A Prospective Study
Actual Study Start Date : February 1, 2022
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : April 30, 2024


Group/Cohort Intervention/treatment
Patient controlled analgesia (PCA) group
Patients in this group will be allocated to the PCA arm, i.e., they will be receiving a PCA pump for administration of opioids.
Drug: Opioid
Patients with acute pancreatitis will be divided into two groups - patient controlled analgesia (PCA) and physician-directed analgesia (PDA). Opioids are routinely administered as standard of care for treating pain associated with acute pancreatitis. Patients in the PCA group will be receiving opioids via a PCA pump, that the patient can use to self-regulate the dose and timing of drug administration. We will follow a specific protocol that has been designed by our pain physician for the PCA pump. Patients in the PDA arm will receive PRN opioids as directed by the physician, which will be administered by the nurse.

Physician directed analgesia (PDA) group
Patients in this group will be allocated to the PDA arm, i.e., they will be receiving opioids administered by the nurse, as and when directed by the physician.
Drug: Opioid
Patients with acute pancreatitis will be divided into two groups - patient controlled analgesia (PCA) and physician-directed analgesia (PDA). Opioids are routinely administered as standard of care for treating pain associated with acute pancreatitis. Patients in the PCA group will be receiving opioids via a PCA pump, that the patient can use to self-regulate the dose and timing of drug administration. We will follow a specific protocol that has been designed by our pain physician for the PCA pump. Patients in the PDA arm will receive PRN opioids as directed by the physician, which will be administered by the nurse.




Primary Outcome Measures :
  1. Length of stay (days) [ Time Frame: Through hospital stay, an average of 5-7 days ]

Secondary Outcome Measures :
  1. Number of hours the patient gets nothing by mouth (NPO) before diet is initiated [ Time Frame: An average of 1-2 days into the hospital stay ]
  2. Mean pain scores on numeric rating scale (NRS) over the first 24 hours, second 24 hours and course of their hospital stay [ Time Frame: Day 1 of hospitalization ]
  3. Overall patient satisfaction with pain control (Likert scale 1-10) [ Time Frame: Through hospital stay, an average of 5-7 days ]
  4. Total opioid dose for pain control during hospitalization (average morphine milliequivalents during hospital stay) [ Time Frame: Through hospital stay, an average of 5-7 days ]
  5. Time to transition to PO opioids [ Time Frame: Through hospital stay, an average of 5-7 days ]
  6. Opioid-related adverse events/side effects [ Time Frame: Through hospital stay, an average of 5-7 days ]
  7. Use of naloxone and antiemetics [ Time Frame: Through hospital stay, an average of 5-7 days ]
  8. Number of rescue doses of opioids required daily and in total through the hospital stay [ Time Frame: Through hospital stay, an average of 5-7 days ]
  9. ICU transfer [ Time Frame: Through hospital stay, an average of 5-7 days ]
  10. 30-day readmission rates [ Time Frame: 30 days ]
  11. All-cause inpatient mortality and opioid-related inpatient mortality [ Time Frame: Through hospital stay, an average of 5-7 days ]
  12. 30-day mortality [ Time Frame: 30 days ]
  13. Daily morphine milliequivalents on discharge [ Time Frame: Through hospital stay, an average of 5-7 days ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients diagnosed with acute pancreatitis who are admitted to our hospital (BIDMC) and meet above mentioned inclusion criteria will be enrolled in the study.
Criteria

Inclusion Criteria:

  • Diagnosis of acute pancreatitis confirmed by revised Atlanta criteria
  • Admitted to the medical floor within 48 hours of emergency department arrival at Beth Israel Deaconess Medical Center (BIDMC) in Boston, Massachusetts.
  • Age 18-65

Exclusion Criteria:

  • Active illicit drug use
  • Discharged from the emergency department
  • Direct admission to ICU from emergency department
  • Known allergy to opioid medications
  • Age <18 or >65
  • Known chronic pain syndrome or concurrent other medical condition with chronic pain
  • Active encephalopathy/confusion/delirium/psychiatric illness or any other condition that limits capacity
  • Known chronic opioid use
  • Renal insufficiency (baseline Creatinine of >2 and/or acute kidney injury with Creatinine>3 on admission)
  • Known allergy to acetaminophen or hepatic dysfunction otherwise limiting acetaminophen use

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04816877


Contacts
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Contact: Sunil Sheth, MD 617-667-7957 ssheth@bidmc.harvard.edu

Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Sunil Sheth, MD    617-667-7957    ssheth@bidmc.harvard.edu   
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
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Responsible Party: Sunil Sheth, Associate Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT04816877    
Other Study ID Numbers: 2021P000203
First Posted: March 25, 2021    Key Record Dates
Last Update Posted: July 21, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents