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

Primary Purpose

Forearm Fracture

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lidocaine
Saline
Sponsored by
Rhode Island Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Forearm Fracture focused on measuring Hematoma block, Lidocaine, Forearm fracture, Radius fracture, Ulna fracture, Ketamine, Midazolam, Procedural sedation

Eligibility Criteria

3 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hasbro Children's Hospital/Rhode Island Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lidocaine

Normal Saline

Arm Description

Subjects randomly assigned to this arm will receive 2% lidocaine by injection into their fracture site in the form of a hematoma block.

Subjects randomly assigned to this arm will receive normal saline by injection into their fracture site

Outcomes

Primary Outcome Measures

Total sedation time

Secondary Outcome Measures

Non-union
Need for re-manipulation
Adverse effects of sedation
Adverse effects of hematoma block
Pain control

Full Information

First Posted
September 26, 2008
Last Updated
November 18, 2013
Sponsor
Rhode Island Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00763880
Brief Title
Hematoma Block as an Adjunct to Procedural Sedation for Forearm Fracture Reduction
Official Title
Hematoma Blocks in Forearm Fractures: An Effective Adjunct to Procedural Sedation?
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Why Stopped
Recruitment was taking longer than originally anticipated.
Study Start Date
November 2005 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rhode Island Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Forearm Fracture
Keywords
Hematoma block, Lidocaine, Forearm fracture, Radius fracture, Ulna fracture, Ketamine, Midazolam, Procedural sedation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine
Arm Type
Experimental
Arm Description
Subjects randomly assigned to this arm will receive 2% lidocaine by injection into their fracture site in the form of a hematoma block.
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
Subjects randomly assigned to this arm will receive normal saline by injection into their fracture site
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
Xylocaine, Lidocaine hydrochloride
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Sodium Chloride
Intervention Description
Volume of normal saline equivalent to providing 2.5mg/kg of 2% lidocaine, to a maximum of 10mL.
Primary Outcome Measure Information:
Title
Total sedation time
Time Frame
Evaluated upon completion of procedure
Secondary Outcome Measure Information:
Title
Non-union
Time Frame
1 month
Title
Need for re-manipulation
Time Frame
1 week
Title
Adverse effects of sedation
Time Frame
For the duration of the procedure
Title
Adverse effects of hematoma block
Time Frame
1 month
Title
Pain control
Time Frame
For entire duration of procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erika Constantine, MD
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hasbro Children's Hospital/Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

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

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