Epidural vs. Systemic Analgesia in the Intensive Care Unit

NCT ID: NCT04996524

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 647 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2023-04-01

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

epidural analgesia group

Group Type: EXPERIMENTAL

epidural analgesia

Intervention Type: DRUG

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

systemic analgesia group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

epidural analgesia

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

sara dichtwald

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Meir medical center Kfar Saba

Kfar Saba, , Israel

Countries

Israel

Other Identifiers

0158-21-MMC

Identifier Type: -

Identifier Source: org_study_id