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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00763880
Recruitment Status : Terminated (Recruitment was taking longer than originally anticipated.)
First Posted : October 1, 2008
Last Update Posted : November 19, 2013
Information provided by (Responsible Party):
Erika Constantine, Rhode Island Hospital

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.

Condition or disease Intervention/treatment Phase
Forearm Fracture Drug: Lidocaine Drug: Saline Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hematoma Blocks in Forearm Fractures: An Effective Adjunct to Procedural Sedation?
Study Start Date : November 2005
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

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 Name: Sodium Chloride

Primary Outcome Measures :
  1. Total sedation time [ Time Frame: Evaluated upon completion of procedure ]

Secondary Outcome Measures :
  1. Non-union [ Time Frame: 1 month ]
  2. Need for re-manipulation [ Time Frame: 1 week ]
  3. Adverse effects of sedation [ Time Frame: For the duration of the procedure ]
  4. Adverse effects of hematoma block [ Time Frame: 1 month ]
  5. Pain control [ Time Frame: For entire duration of procedure ]

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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00763880

United States, Rhode Island
Hasbro Children's Hospital/Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Rhode Island Hospital
Principal Investigator: Erika Constantine, MD Rhode Island Hospital

Responsible Party: Erika Constantine, Clinical Assistant Professor, Rhode Island Hospital Identifier: NCT00763880     History of Changes
Other Study ID Numbers: CMTT # 4040-05
First Posted: October 1, 2008    Key Record Dates
Last Update Posted: November 19, 2013
Last Verified: November 2013

Keywords provided by Erika Constantine, Rhode Island Hospital:
Hematoma block
Forearm fracture
Radius fracture
Ulna fracture
Procedural sedation

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries
Pathologic Processes
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action