Hematoma Block as an Adjunct to Procedural Sedation for Forearm Fracture Reduction

Hematoma Blocks in Forearm Fractures: An Effective Adjunct to Procedural Sedation?

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00763880

Enrollment

Registered

2008-10-01

Start date

2005-11-30

Completion date

2008-09-30

Last updated

2013-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Forearm Fracture

Keywords

Hematoma block, Lidocaine, Forearm fracture, Radius fracture, Ulna fracture, Ketamine, Midazolam, Procedural sedation

Brief summary

The purpose of our study is to determine if the use of a hematoma block together with intravenous sedation and analgesia is an effective means of managing forearm fractures in the Emergency Department. To determine this, we have designed a randomized, double-blind, placebo controlled trial of hematoma block versus saline for the manipulation of forearm fractures under conscious sedation with ketamine and midazolam. Our hypotheses are two-fold: First, the use of a hematoma block together with conscious sedation will allow for improved pain control. Second, the use of a hematoma block together with conscious sedation will allow us to use less sedation, therefore promoting faster recovery from sedation and more efficient patient turnover in the Emergency Department.

Interventions

DRUGLidocaine

2% Lidocaine (no epinephrine) in the dose of 2.5 mg/kg to a maximum of 10mL will be instilled once into the fracture site in the form of a hematoma block.

DRUGSaline

Volume of normal saline equivalent to providing 2.5mg/kg of 2% lidocaine, to a maximum of 10mL.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

3 Years to 17 Years

Healthy volunteers

Yes

Inclusion criteria

* English or Spanish speaking * Ages 3-17 * Closed distal forearm fracture requiring reduction under sedation in the Emergency Department * Fracture involves the distal third of the forearm

Exclusion criteria

* Multiple trauma victims * Associated nerve or vascular damage * Associated elbow or humerus injury * Sensitivity or allergy to lidocaine * Contraindications to procedural sedation * Previous attempts at reduction for the same injury

Design outcomes

Primary

Measure	Time frame
Total sedation time	Evaluated upon completion of procedure

Secondary

Measure	Time frame
Non-union	1 month
Need for re-manipulation	1 week
Adverse effects of sedation	For the duration of the procedure
Adverse effects of hematoma block	1 month
Pain control	For entire duration of procedure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026