Regional Anesthesia for Sickle Cell Crisis Using Ultrasound in The Emergency Department: Phase I

NCT01256281 | Terminated Phase 1 Results DMC

• 1 other identifier: 10-0934
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis of this study is: Femoral nerve blocks can feasibly be performed on patients with Sickle Cell Disease and painful crisis in the Emergency Department.

Conditions

Sickle Cell Disease

Keywords

Sickle Cell Disease; Pain; Vasoocclusion; Nerve Block; Regional Anesthesia

Outcome Measures

Primary Outcomes (1)

• Pain Score in Legs (0-10)

  Pain score in legs at 2-4 hours after intervention will be the primary outcome. Data analysis not done.

  2-4 hours after intervention

Study Arms (1)

Femoral Nerve Block

EXPERIMENTAL

Patients enrolled will receive ultrasound guided FNB in addition to standard care. If subjects are experiencing pain in both lower extremities, both extremities will be blocked; if subjects are experiencing pain in one lower extremity, only the affected extremity will be blocked.

Procedure: Femoral Nerve Block

Interventions

Femoral Nerve Block PROCEDURE

Patients enrolled will receive ultrasound guided FNB in addition to standard care. If subjects are experiencing pain in both lower extremities, both extremities will be blocked; if subjects are experiencing pain in one lower extremity, only the affected extremity will be blocked.

Femoral Nerve Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or above
• Documented SCD: HbSS, HbSC, HbSβ0Thal, HbSβ+Thal
• Rapid onset of acute pain consistent with VOC
• Pain in at least one lower extremity
• Pain requiring admission to the hospital
• Cognitive ability to report pain on a 0-10 NRS

You may not qualify if:

• Primary admitting diagnosis other than VOC
• Contraindication to femoral nerve block
• Pregnant

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Pain

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

study was terminated due to lack of resources. no data analysis for this study.

Results Point of Contact

• Title: Dr. Jeffrey Glassberg
• Organization: Icahn School of Medicine at Mount Sinai

jeffrey.glassberg@mountsinai.org

(212) 824-8056

Study Officials

• Jeffrey D Glassberg, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2010
• First Posted: December 8, 2010
• Study Start: September 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: April 23, 2015
• Results First Posted: April 23, 2015

Record last verified: 2015-04

Locations

US (1)