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Epidural vs. Systemic Analgesia in the Intensive Care Unit

Primary Purpose

Patients With Acute Pain Admitted to the Intensive Care Unit

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
epidural analgesia
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients With Acute Pain Admitted to the Intensive Care Unit focused on measuring acute pain, epidural analgesia, intensive care unit

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:Patients aged 18-99, admitted to the General Intensive Care Unit from January 2011 to June 2021 (inclusive), due to a medical condition that may expose them to significant pain during hospitalization: chest, abdominal, pelvic or lower extremity surgery, pancreatitis, multiple rib fractures, trauma including chest, abdominal, pelvic, or lower limb trauma, and treated with epidural or systemic anesthesia during their stay in the unit.

-

Exclusion Criteria:Patients not admitted for the above reasons. -

Sites / Locations

  • Meir medical center Kfar SabaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

epidural analgesia group

systemic analgesia group

Arm Description

Outcomes

Primary Outcome Measures

delirium score
To compare delirium score, as measured by RASS score, between the epidural group and the systemic analgesia group

Secondary Outcome Measures

pain score
To compare pain score, as measured by VAS score, between the epidural group and the systemic analgesia group

Full Information

First Posted
July 29, 2021
Last Updated
April 12, 2022
Sponsor
Meir Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04996524
Brief Title
Epidural vs. Systemic Analgesia in the Intensive Care Unit
Official Title
Epidural vs. Systemic Analgesia in the Intensive Care Unit: Retrospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meir Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Many patients admitted to the general intensive care unit suffer from pain, whether acute or chronic. Those patients include post-operative patients, multi trauma, acute pancreatitis and patients with multiple rib fractures. Most patients in the intensive care unit, whether intubated and ventilated or not, are treated with systemic analgesic drugs, usually given intravenously, enterally, or trans dermally (fentanyl patches). Continuous epidural anesthesia has been shown in several studies to have an advantage over systemic analgesia in specific conditions, such as pancreatitis, multiple rib fractures and upper abdominal surgeries. Some of its benefits include improved gastrointestinal motility (reduction of ileus rates), decreased thromboembolic events (DVT) and better quality of pain control. In intubated and ventilated patients, continuous epidural anesthesia may reduce the amount of required systemic sedation. Reducing the amount of sedation may contribute to a decrease in delirium rates, shortening the time to extubation and reducing other adverse effects associated with high requirements of sedation drugs (such as a decrease in blood pressure). Most of the studies comparing systemic analgesia to epidural analgesia examined a population of patients hospitalized in the surgical ward, post breast, abdominal or orthopedic surgeries of the pelvis and lower extremities, or due to other conditions such as pancreatitis or multiple rib fractures. There are almost no studies that have examined the effectiveness of epidural analgesia in patients admitted to the intensive care unit, including sedated and ventilated patients, compared with systemic analgesia. From 2011 until today, our intensive care unit has admitted about 300 patients who were treated with continuous epidural analgesia. In this study we would like to compare them to another group of patients (about 300 patients as well), who were admitted to the unit for similar etiologies (post-operative, multi- trauma, pancreatitis, etc.), and to observe differences between the groups. We would like to examine differences in mortality within 28 days, as well as differences in morbidity, such as the level of analgesia and delirium rates between groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Acute Pain Admitted to the Intensive Care Unit
Keywords
acute pain, epidural analgesia, intensive care unit

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
epidural analgesia group
Arm Type
Experimental
Arm Title
systemic analgesia group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
epidural analgesia
Intervention Description
Patients recieving epidural analgesia instead of systemic analgesia for acute pain in the intensive care unit
Primary Outcome Measure Information:
Title
delirium score
Description
To compare delirium score, as measured by RASS score, between the epidural group and the systemic analgesia group
Time Frame
6 months post ICU admission
Secondary Outcome Measure Information:
Title
pain score
Description
To compare pain score, as measured by VAS score, between the epidural group and the systemic analgesia group
Time Frame
6 months post ICU admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:Patients aged 18-99, admitted to the General Intensive Care Unit from January 2011 to June 2021 (inclusive), due to a medical condition that may expose them to significant pain during hospitalization: chest, abdominal, pelvic or lower extremity surgery, pancreatitis, multiple rib fractures, trauma including chest, abdominal, pelvic, or lower limb trauma, and treated with epidural or systemic anesthesia during their stay in the unit. - Exclusion Criteria:Patients not admitted for the above reasons. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Dichtwald, Dr
Phone
972-9-7472133
Ext
1
Email
sara.dichtwald@clalit.org.il
Facility Information:
Facility Name
Meir medical center Kfar Saba
City
Kfar Saba
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
sara dichtwald, MD
Phone
972-9-7472133
Email
sara.dichtwald@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Brian Fredman, Prof
Phone
972-9-7471545
Email
fredman.brian@clalit.org.il

12. IPD Sharing Statement

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Epidural vs. Systemic Analgesia in the Intensive Care Unit

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