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

This study has been terminated.
(Recruitment was taking longer than originally anticipated.)
Sponsor:
Information provided by (Responsible Party):
Erika Constantine, Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT00763880
First received: September 26, 2008
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Forearm Fracture
Drug: Lidocaine
Drug: Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hematoma Blocks in Forearm Fractures: An Effective Adjunct to Procedural Sedation?

Resource links provided by NLM:


Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • Total sedation time [ Time Frame: Evaluated upon completion of procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Non-union [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Need for re-manipulation [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
  • Adverse effects of sedation [ Time Frame: For the duration of the procedure ] [ Designated as safety issue: Yes ]
  • Adverse effects of hematoma block [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Pain control [ Time Frame: For entire duration of procedure ] [ Designated as safety issue: No ]

Enrollment: 89
Study Start Date: November 2005
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Saline
  • Sodium Chloride

  Eligibility

Ages Eligible for Study:   3 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00763880

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

No publications provided

Responsible Party: Erika Constantine, Clinical Assistant Professor, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT00763880     History of Changes
Other Study ID Numbers: CMTT # 4040-05
Study First Received: September 26, 2008
Last Updated: November 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Rhode Island Hospital:
Hematoma block
Lidocaine
Forearm fracture
Radius fracture
Ulna fracture
Ketamine
Midazolam
Procedural sedation

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

ClinicalTrials.gov processed this record on October 01, 2014