Epidural vs. Systemic Analgesia in the Intensive Care Unit

NCT04996524 | Completed

• 1 other identifier: 0158-21-MMC
• Study Type: interventional
• Target: 647
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients With Acute Pain Admitted to the Intensive Care Unit

Keywords

acute pain, epidural analgesia, intensive care unit

Outcome Measures

Primary Outcomes (1)

• delirium score

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

  6 months post ICU admission

Secondary Outcomes (1)

• pain score

  6 months post ICU admission

Study Arms (2)

epidural analgesia group

EXPERIMENTAL

Drug: epidural analgesia

systemic analgesia group

NO INTERVENTION

Interventions

epidural analgesia DRUG

Patients recieving epidural analgesia instead of systemic analgesia for acute pain in the intensive care unit

epidural analgesia group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Meir medical center Kfar Saba

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Analgesia, Epidural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 9, 2021
• Study Start: August 1, 2021
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

IL (1)