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

Phase 4

Terminated

• Conditions: Forearm Fracture
• Interventions: Drug: Saline; Drug: Lidocaine

• Registration Number: NCT00763880
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Study First Submitted: 2008-09-26
• Study First Submitted QC: 2008-09-26
• Study First Posted: 2008-10-01
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-18
• Last Update Posted: 2013-11-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 89

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Normal Saline	Saline	Subjects randomly assigned to this arm will receive normal saline by injection into their fracture site
Lidocaine	Lidocaine	Subjects randomly assigned to this arm will receive 2% lidocaine by injection into their fracture site in the form of a hematoma block.

Primary Outcome Measures

Name	Time	Method
Total sedation time	Evaluated upon completion of procedure

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hasbro Children's Hospital/Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States