NCT03590782

Brief Summary

Rib fractures are a common cause of respiratory distress in trauma patients as poor pain control and subsequent hypoventilation commonly results in lung tissue collapse (atelectasis). The current mainstay of treatment in rib fractures are oral and intravenous opioids however these are often ineffective and can also precipitate hypoventilation. Recently there has been interest in regional anaesthesia techniques for managing painful conditions of the thorax as a way to avoid pain and opioid related hypoventilation. These techniques include ultrasound guided nerve blocks such as the intercostal, paravertebral and serratus anterior blocks. The use of these techniques is however limited by minimal dermatomal coverage as well as a high incidence of complications The erector spinae plane block is a new, very promising technique which offers a safe means of providing anaesthesia to a large part of the hemithorax with a single injection. The proposed study will seek to establish whether the erector spinae plane block can be successfully used in the emergency department for pain control in patients with acute rib fractures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 18, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

October 12, 2020

Status Verified

October 1, 2020

Enrollment Period

1.6 years

First QC Date

July 4, 2018

Last Update Submit

October 9, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visual analogue pain scale

    Pain scale with be taken pre- and post-block and regular intervals. The visual analogue pain scale ranges from 0-10, with 0 being no pain and 10 being the worse pain imaginable. Lower numerical scores are better for outcomes as it implies that the pain is more well managed.

    30-60 minutes

Interventions

An ultrasound guided erector spinae block will be performed.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with acute rib fractures failing traditional therapy.

You may qualify if:

  • Patients over the age of 18
  • Acute rib fractures with pain that is subjectively poorly controlled despite oral and/or intravenous opioids.

You may not qualify if:

  • Hemodynamic instability,
  • Active infection overlying the site of injection
  • Patients receiving anticoagulation
  • Patients with a history of a bleeding disorder
  • Patients with thrombocytopenia
  • Pregnant, are incarcerated
  • Decline the procedure
  • Inability to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Sciences Centre

Winnipeg, Manitoba, R3A1R9, Canada

Location

MeSH Terms

Conditions

Rib Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesThoracic Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2018

First Posted

July 18, 2018

Study Start

March 1, 2019

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

October 12, 2020

Record last verified: 2020-10

Locations