US-guided SAPB for Rib Fractures in the ED

Andrew A Herring

Status and phase: Unknown; Phase 4

Conditions: Rib Fracture Multiple; Rib Fractures

Treatments: Drug: Fentanyl, morphine, hydromorphone, hydrocodone, acetaminophen, ketorolac, gabapentin, ketamine, ibuprofen; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03619785

17-10102B

Details and patient eligibility

About

The purpose of this randomized controlled study is to determine whether the serratus anterior plane block reduces pain more than the usual treatment for rib fractures in the same amount of time.

Full description

Patients with unilateral rib fractures in the Highland Hospital Emergency Department who agree to participate will be randomized 1:1 to either the control group or the experimental group. Those in the control group will receive the usual oral and/or IV pain medication as needed. The experimental group will receive an ultrasound-guided serratus anterior plane block. Numerical pain rating scale scores at rest and when taking a deep breath will be recorded pre-intervention and at times 0, 20, 40, and 60. At time 60, patients who received the SAPB will receive sensory testing. Patients will be offered additional pain medication as needed at times 20, 40, and 60.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females 18 years and older, capable of providing informed consent indicating awareness of the investigational nature of the study, in keeping with institutional policy.
• Written informed consent must be obtained from each patient prior to entering the study.
• Patients with moderate to severe pain (NRS 4 to 10) as a result of one or more rib fractures occurring at levels T2-T8, measured on a self-reported NRS.

Exclusion criteria

• Patient refusal
• Patients with significant pain from other injuries (as determined at the discretion of the treating physician)
• Patients deemed critically ill by provider
• Patients with decompensated psychiatric disorders
• Pregnant patients (positive urine or serum B-HCG)
• History of heart block or bradycardia
• History of uncontrolled seizures
• Patients allergic to lidocaine, bupivacaine, ropivacaine, or morphine
• Patients with bilateral rib fractures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Experimental (SAPB)

Experimental group

Description:

Patients randomized to the experimental arm receive an ultrasound-guided serratus anterior plane block for their rib fracture pain.

Treatment:

Drug: Bupivacaine

Control

Active Comparator group

Description:

Patients randomized to the control arm receive usual pain control treatment in the emergency department.

Treatment:

Drug: Fentanyl, morphine, hydromorphone, hydrocodone, acetaminophen, ketorolac, gabapentin, ketamine, ibuprofen