Clinical trial NCT06519929: Analgesic Techniques for Rib Fractures
Official title: A Pilot Study Comparing Three Analgesia Approaches for Rib Fractures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Rib Fractures
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 24
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3-arm, parallel-group, randomized controlled trial
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: Inclusion Criteria:

* ≥ 55 years old
* Sustained 3 or more unilateral rib fractures and are admitted to the hospital

Exclusion Criteria:

* Allergy to amide local anesthetics or any study medications
* Pregnancy
* Bilateral rib fractures
* Coagulopathy (INR \> 1.5; platelets \< 100,000)
* Conduction block on EKG
* 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

Primary outcomes:
measure: Opioid Use in oral morphine equivalents (OME)
timeFrame: 72 Hours
measure: Brief Pain Inventory - current pain subscale (0-10)
timeFrame: 0-72 Hours
Secondary outcomes:
measure: Daily opioid use
timeFrame: 30 Days
measure: Daily opioid Use
timeFrame: 90 Days
measure: Brief Pain Inventory
timeFrame: Days 1-3
measure: Brief Pain Inventory
timeFrame: Day 30
measure: Brief Pain Inventory
timeFrame: Day 90
measure: Vital capacity (mL)
timeFrame: Baseline prior to intervention
measure: Vital capacity (mL)
timeFrame: Day 1
measure: Vital capacity (mL)
timeFrame: Day 2
measure: Vital capacity (mL)
timeFrame: Day 3
measure: Duke Activity Status Index
timeFrame: Baseline prior to intervention
measure: Short-form 12
timeFrame: Baseline prior to intervention
measure: Short-form 12
timeFrame: Day 30
measure: Short-form 12
timeFrame: Day 90
measure: 3D-CAM/CAM-ICU
timeFrame: Day 1
measure: 3D-CAM/CAM-ICU
timeFrame: Day 2
measure: 3D-CAM/CAM-ICU
timeFrame: Day 3
measure: Respiratory depression
timeFrame: Days 1-3
measure: Epidural eligibility
timeFrame: Day 1
measure: RibScore
timeFrame: Day 1
measure: Presence of perioral numbness
timeFrame: Day 1
measure: Presence of perioral numbness
timeFrame: Day 2
measure: Presence of perioral numbness
timeFrame: Day 3
measure: Presence of tinnitus
timeFrame: Day 1
measure: Presence of tinnitus
timeFrame: Day 2
measure: Presence of tinnitus
timeFrame: Day 3
measure: Presence of metallic taste
timeFrame: Day 1
measure: Presence of metallic taste
timeFrame: Day 2
measure: Presence of metallic taste
timeFrame: Day 3
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Eric Schwenk, MD
role: PRINCIPAL_INVESTIGATOR
References: