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

November 18, 2013 updated by: Erika Constantine, Rhode Island Hospital

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Hasbro Children's Hospital/Rhode Island Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lidocaine
Subjects randomly assigned to this arm will receive 2% lidocaine by injection into their fracture site in the form of a hematoma block.
Drug: Lidocaine
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.
Other Names:
  • Xylocaine
  • Lidocaine hydrochloride
Placebo Comparator: Normal Saline
Subjects randomly assigned to this arm will receive normal saline by injection into their fracture site
Drug: Saline
Volume of normal saline equivalent to providing 2.5mg/kg of 2% lidocaine, to a maximum of 10mL.
Other Names:
  • Sodium Chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total sedation time
Time Frame: Evaluated upon completion of procedure
Evaluated upon completion of procedure

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rhode Island Hospital

Investigators

  • Principal Investigator: Erika Constantine, MD, Rhode Island Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

September 26, 2008

First Submitted That Met QC Criteria

September 26, 2008

First Posted (Estimate)

October 1, 2008

Study Record Updates

Last Update Posted (Estimate)

November 19, 2013

Last Update Submitted That Met QC Criteria

November 18, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMTT # 4040-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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