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NCT06519929 · ClinicalTrials.gov registry record · Phase 4

Analgesic Techniques for Rib Fractures

A Phase 4 study of Rib Fractures, sponsored by Thomas Jefferson University.

Active
Registry status
Phase 4
Development phase
24
Enrollment target
1
Study location

NCT06519929 is a Phase 4 study of Rib Fractures that is active but no longer recruiting, run by Thomas Jefferson University. The registered enrollment target is 24 participants, below the 98-participant average among 9 other Rib Fractures trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06519929, a Phase 4 study of Rib Fractures, is active but no longer recruiting, sponsored by Thomas Jefferson University.

ACTIVE NOT RECRUITING
Registry status
Phase 4
Development phase
24 participants
Enrollment target
1
Study location

Study Summary

This study will be a 3-arm, parallel-group, randomized controlled trial comparing three analgesic techniques for rib fractures with a sample size of 24 patients (8 per group). Patients will be randomly assigned to one of the following three groups: 1) ESP block with catheter using ropivacaine (bolus followed by continuous infusion); 2) lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h; or 3) standard care with multimodal analgesia and opioids. Our specific aims are: 1. To compare the opioid use and pain ratings over the first 72 hours after enrollment. 2. To quantify the changes in vital capacity, oxygen requirement, and freedom from mechanical ventilation that result from the intervention. 3. To explore the impact of ESP blocks and lidocaine infusions on the development of chronic pain and post-discharge opioid use (exploratory). Inclusion Criteria: • Adult patients ≥ 55 years old who have sustained 3 or more unilateral rib fractures and are admitted to the hospital. Exclusion Criteria: * Allergy to amide local anesthetics, lidocaine, or ropivacaine * Pregnancy * Bilateral rib fractures * Coagulopathy (INR \> 1.5; PTT \> 1.5 times ULN, or platelets \< 75,000) * Conduction block on EKG * Total body weight \< 40 kg * Painful distracting injuries: acute thoracic spine fracture, severe traumatic brain injury or spinal cord injury, unstable pelvic fracture, open abdomen * Spine fracture at the level of intended ESP block * Infection near the ESP insertion site or active bacteremia or sepsis * Any patient deemed a poor candidate for ESP block and/or lidocaine infusion will also be excluded

Conditions Studied

Interventions

  • PROCEDURE ESP block with catheter using ropivacaine (bolus followed by continuous infusion)
  • DRUG Lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h

Study Locations (1)

Pennsylvania

  • Thomas Jefferson University Hospital - Philadelphia

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2024-09-23
Est. Completion 2025-12-01
Phase Phase 4

Sponsor

Thomas Jefferson University

292 total trials

What the Registry Record Tells You About NCT06519929

The ClinicalTrials.gov registry entry for NCT06519929 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 98-participant average among 9 other Rib Fractures trials with a reported enrollment target (76% lower). The listed sponsor is Thomas Jefferson University, which has 292 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Rib Fractures appearing as the primary indexed condition, and to 2 interventions - of which ESP block with catheter using ropivacaine (bolus followed by continuous infusion) is the first listed.

NCT06519929 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT06519929 about?

NCT06519929 is a clinical study titled "Analgesic Techniques for Rib Fractures". This study will be a 3-arm, parallel-group, randomized controlled trial comparing three analgesic techniques for rib fractures with a sample size of 24 patients (8 per group). Patients will be randomly assigned to one of the following three groups: 1) ESP block with catheter using ropivacaine (bolus...

What is the current status of trial NCT06519929?

This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 24 participants. The study started on 2024-09-23. Estimated completion is 2025-12-01.

What conditions does trial NCT06519929 study?

This clinical trial studies the following conditions: Rib Fractures.

What interventions are being tested in trial NCT06519929?

The interventions under investigation include: ESP block with catheter using ropivacaine (bolus followed by continuous infusion) (PROCEDURE), Lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h (DRUG).

Who is sponsoring clinical trial NCT06519929?

This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06519929 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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