ACTIVE_NOT_RECRUITING

Analgesic Techniques for Rib Fractures

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Pilot Study Comparing Three Analgesia Approaches for Rib Fractures

Quick Facts

Study Start:2024-09-23
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06519929

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥ 55 years old
  2. * Sustained 3 or more unilateral rib fractures and are admitted to the hospital
  1. * Allergy to amide local anesthetics or any study medications
  2. * Pregnancy
  3. * Bilateral rib fractures
  4. * Coagulopathy (INR \> 1.5; platelets \< 100,000)
  5. * Conduction block on EKG
  6. * Spine fracture at the level of intended ESP block
  7. * Infection near the ESP insertion site or active bacteremia or sepsis
  8. * Any patient deemed a poor candidate for ESP block and/or lidocaine infusion will also be excluded

Contacts and Locations

Principal Investigator

Eric Schwenk, MD
PRINCIPAL_INVESTIGATOR
Thomas Jefferson University

Study Locations (Sites)

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
United States

Collaborators and Investigators

Sponsor: Thomas Jefferson University

  • Eric Schwenk, MD, PRINCIPAL_INVESTIGATOR, Thomas Jefferson University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-23
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2024-09-23
Study Completion Date2025-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • Rib Fractures