Hematoma Block as an Adjunct to Procedural Sedation for Forearm Fracture Reduction
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 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?|
- Total sedation time [ Time Frame: Evaluated upon completion of procedure ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||November 2005|
|Study Completion Date:||September 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Subjects randomly assigned to this arm will receive 2% lidocaine by injection into their fracture site in the form of a hematoma block.
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.
Placebo Comparator: Normal Saline
Subjects randomly assigned to this arm will receive normal saline by injection into their fracture site
Volume of normal saline equivalent to providing 2.5mg/kg of 2% lidocaine, to a maximum of 10mL.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00763880
|United States, Rhode Island|
|Hasbro Children's Hospital/Rhode Island Hospital|
|Providence, Rhode Island, United States, 02903|
|Principal Investigator:||Erika Constantine, MD||Rhode Island Hospital|