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Clinical Trials/NCT03619785
NCT03619785
Unknown
Phase 4

Ultrasound-guided (US) Serratus Anterior Plane Block (SAPB) for Acute Rib Fractures in the Emergency Department (ED)

Andrew A Herring1 site in 1 country70 target enrollmentNovember 6, 2018

Overview

Phase
Phase 4
Intervention
Bupivacaine
Conditions
Rib Fractures
Sponsor
Andrew A Herring
Enrollment
70
Locations
1
Primary Endpoint
Change in Numeric Pain Rating Scale score between time 0 and time 60 when comparing block and control groups
Last Updated
7 years ago

Overview

Brief Summary

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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
November 6, 2018
End Date
August 31, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Andrew A Herring
Responsible Party
Sponsor Investigator
Principal Investigator

Andrew A Herring

Associate Research Director, Department of Emergency Medicine, Highland Hospital

Alameda Health System

Eligibility Criteria

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

Arms & Interventions

Experimental (SAPB)

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

Intervention: Bupivacaine

Control

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

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

Outcomes

Primary Outcomes

Change in Numeric Pain Rating Scale score between time 0 and time 60 when comparing block and control groups

Time Frame: 60 minutes

Change in Numeric Pain Rating Scale scores between time 0 and time 60 between block and control groups: Numeric Pain Rating Scale score at 0 minutes minus Numeric Pain Rating Scale score at 60 minutes, where a score of 0 is no pain and 10 is the worst pain the patient can imagine.

Secondary Outcomes

  • Adverse events(60 minutes)
  • Sensory testing(60 minutes)
  • Non-opioid medications given (yes/no)(20, 40, 60 minutes)
  • Change in Numeric Pain Rating Scale score at rest versus when taking a deep breath when comparing block and control groups(20, 40, 60 minutes)
  • Successful analgesia for block group(20, 40, 60 minutes)
  • Difference in total morphine equivalents(1, 4, 12, and 24 hours)

Study Sites (1)

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