Analgesic Techniques for Rib Fractures

Thomas Jefferson University

Status and phase: Active, not recruiting; Phase 4

Conditions: Rib Fractures

Treatments: Drug: Lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h; Procedure: ESP block with catheter using ropivacaine (bolus followed by continuous infusion)

Study type: Interventional

Funder types: Other

Identifiers

NCT06519929

IRISID-2022-1186

Details and patient eligibility

About

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

Enrollment: 24 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 3 patient groups

ESP block with catheter using ropivacaine (bolus followed by continuous infusion)

Experimental group

Treatment:

Procedure: ESP block with catheter using ropivacaine (bolus followed by continuous infusion)

Lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h

Active Comparator group

Treatment:

Drug: Lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h

Standard care with multimodal analgesia and opioids

No Intervention group