Trauma Clinical Trial - Liposomal Bupivacaine Intercostal Nerve Block vs

Status Recruiting

Clinical Trial Summary

Management of traumatic rib fractures continues to be a challenge for trauma surgeons. Currently, many analgesic options are available to patients suffering from rib fractures. Formulations currently used for conventional intercostal nerve blocks (CINB) are relatively safe, do not require additional equipment or specialized anesthesia personnel, do not require catheter repositioning, and provide improved analgesia immediately over the aforementioned systemic therapies. A goal of these authors to introduce an additional safe option for extended local analgesia in the setting of multiple rib fractures given the inconclusive evidence supporting or refuting the current standard of care

Clinical Trial Description

The objective of this study is to quantify and draw inferences on the efficacy of a multiple level liposomal bupivacaine intercostal nerve blockade (LBINB) in patients with multiple traumatic rib fractures.

The primary objective is to assess the quality and duration of analgesia based on numeric grading pain scale, improvement in pulmonary function parameters, reduction pulmonary complications, and duration of hospitalization in patients receiving LBINBs relative to those receiving the current standard of care, CEA, in patients recovering from multiple traumatic rib fractures.

The secondary objective of this study is to assess cost and rate of complications associated with LBINB relative to CEA.

This is a two arm, randomized trial. Patients suffering multiple traumatic rib fractures will be offered CEA or LBINB. As the current standard of care, CEA will serve as the control, and outcomes measured in patients receiving LBINB will be statistically evaluated relative to the CEA control group.

All patients will receive standardized NSAID and opioid analgesia protocol for break through pain, as well as standardized routines for pulmonary hygiene and physiotherapy.

Indications for CEA and LBINB in this study include patients suffering from traumatic thoracic injury with greater than or equal to 3 fractured ribs ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03574376
Study type	Interventional
Source	OSF Healthcare System
Contact	Chadrick R Evans, MD
Phone	309-655-2383
Email	cevans@peoriasurgical.com
Status	Recruiting
Phase	Phase 4
Start date	August 29, 2018
Completion date	August 1, 2021

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04848376` - Post-Market Clinical Follow-up Study of A-SPINE's Products
Terminated	`NCT03781817` - Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures	Phase 4
Completed	`NCT04342416` - Using a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women	N/A
Recruiting	`NCT04856449` - DBT Skills Plus EMDR for BPD and Trauma	N/A
Completed	`NCT04356963` - Adjunct VR Pain Management in Acute Brain Injury	N/A
Completed	`NCT05669313` - The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With ROTEM
Active, not recruiting	`NCT03622632` - Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
Recruiting	`NCT04725721` - Testing FIRST in Youth Outpatient Psychotherapy	N/A
Active, not recruiting	`NCT05530642` - An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel	N/A
Not yet recruiting	`NCT05649891` - Checklists Resuscitation Emergency Department	N/A
Not yet recruiting	`NCT03696563` - FreeO2 PreHospital - Automated Oxygen Titration vs Manual Titration According to the BLS-PCS	N/A
Withdrawn	`NCT03249129` - Identification of Autoantibodies and Autoantigens in the Cerebrospinal Fluid of Patients With Spinal Cord Trauma
Completed	`NCT02240732` - Surgical Tourniquets and Cerebral Emboli	N/A
Completed	`NCT02227979` - Effects of PURPLE Cry Intervention	N/A
Withdrawn	`NCT01169025` - Fentanyl vs. Low-Dose Ketamine for the Relief of Moderate to Severe Pain in Aeromedical Patients	N/A
Recruiting	`NCT01812941` - Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients	N/A
Completed	`NCT01475344` - Fibrinogen Concentrate (FGTW) in Trauma Patients, Presumed to Bleed (FI in TIC)	Phase 1/Phase 2
Completed	`NCT03112304` - Child STEPS for Youth Mental Health in Maine Sustainability	N/A
Completed	`NCT01201863` - Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy	Phase 4
Completed	`NCT01210417` - Trauma Heart to Arm Time	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Liposomal Bupivacaine Intercostal Nerve Block vs Thoracic Epidural for Regional Analgesia in Multiple Rib Fractures

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms