Recruiting

SAPB

Sponsor:

Andrew A Herring

Code:

NCT03619785

Conditions

Rib Fractures

Rib Fracture Multiple

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bupivacaine

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

Study Details

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.

Conditions

Rib Fractures

Rib Fracture Multiple

Study ID

NCT03619785

Start date

Nov 6, 2018

Status verified date

Dec, 2018

Completion date

Aug 31, 2019

Anticipated

Primary completion date

Aug 31, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental (SAPB)

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

active comparator: Control

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

Interventions

Bupivacaine

Patient will be positioned supine or in the lateral decubitus position on the side contralateral to the fracture(s). A 3.5 in 20-gauge needle, extension tubing, and a 30 mL syringe loaded with 0.25% bupivacaine and 3 mL of 1% lidocaine loaded in a 5 mL syringe with a 27-gauge needle will be prepared. The ribs, teres minor, latissimus dorsi, and serratus anterior will be identified with bedside US and the site of entry marked along the lateral aspect of the 4th-5th rib. The skin will be sterilized and lidocaine placed at the site of entry. The needle will be introduced at a steep angle and advanced in-plane, under US-guidance, to the plane superficial to the serratus anterior muscle. A test dose of normal saline will confirm proper needle tip placement with opening of the intramuscular layer. Injection with aliquots of 3-5 mL after negative aspiration will continue until 30mL of 0.25% bupivacaine are administered.

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

Oral or IV pain medication as needed.

Primary outcome measure

  • Change in Numeric Pain Rating Scale score between time 0 and time 60 when comparing block and control groups [ Time Frame: 60 minutes ]

Central Contacts and Locations

Central contacts

Andrew Herring

510-633-7498aherring@alamedahealthsystem.org

Jennifer Sun

510-437-8364jennsun@alamedahealthsystem.org

Locations

Alameda Health System - Highland Hospital

Recruiting

Oakland, California, United States, 94602

Contacts

Jennifer Sun

jennsun@alamedahealthsystem.org

More Information

Sponsor

Andrew A Herring

Last update posted

Dec 19, 2018

Last verified

Dec, 2018

Keywords

  • Nerve Block
  • Serratus Anterior Plane Block
  • Ultrasound
  • Emergency Department

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Andrew A Herring on 2018-12-19.