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

April 6, 2015 updated by: Icahn School of Medicine at Mount Sinai

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Phase I: The feasibility cohort will consist of a convenience sample. Dr. Glassberg will wear the SCD-FNB pager at all times and will enroll patients whenever logistically possible.

Participants: ED patients aged >18 who require admission for vasoocclusive pain involving the lower extremities. Vasoocclusive pain is defined as acute onset of corporeal pain, not controlled by oral analgesics, in a patient with SCD with no other apparent cause.

Description of Standard Analgesic Practices: All patients enrolled in the study will receive standardized care based on ED computer order sets designed by Drs. Shi & Glassberg and other members of the Hematology and Emergency departments (appendix E). Based on NIH52 and American Pain Society53 guidelines and current clinical evidence, these protocols were established to ensure delivery of optimal opiate therapy for patients with VOC pain. Initially, the patient will receive IV doses of opiates at the EP's discretion, followed by initiation of morphine or hydro-morphone PCA (patient controlled analgesia). PCA will continue when patient is moved to the inpatient floor, where care will also be guided by standardized order sets.

Description of the FNB Intervention: Throughout the FNB procedure, the patient will have continuous EKG, NIBP and O2 saturation monitoring. With the patient in the supine position, the leg to be blocked will be slightly abducted and externally rotated. The femoral crease and the area approximately 3 inches above and below is prepped and draped in usual sterile fashion. 1-2 ml of local anesthetic will be injected at the probable site of insertion. A sterile ultrasound probe is used to identify the femoral vessels and the femoral nerve, which usually lies 1-2 cm lateral to the artery. The femoral nerve sheath is then entered under direct visualization. Before injection, the syringe will be gently aspirated with negative blood return to ensure that the needle is not intravascular. 20mL of 0.25% bupivicaine will then be given, and deposition of anesthetic will be visualized within the nerve sheath. Intermittent aspiration and continuous ultrasound visualization during anesthetic delivery will ensure that the tip of the needle has not migrated. Injection will also be stopped and the needle repositioned if the patient complains of new or worsening pain, as this may indicate intraneural injection. 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.

Outcomes: This study is not exploring the efficacy of the intervention, nor is the intervention being compared to a control. Phase one is simply to verify that FNB is a feasible procedure to be performed in the ER in this population.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Femoral Nerve Block
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score in Legs (0-10)
Time Frame: 2-4 hours after intervention

Pain score in legs at 2-4 hours after intervention will be the primary outcome.

Data analysis not done.
2-4 hours after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Jeffrey D Glassberg, MD, Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

December 7, 2010

First Submitted That Met QC Criteria

December 7, 2010

First Posted (Estimate)

December 8, 2010

Study Record Updates

Last Update Posted (Estimate)

April 23, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-0934

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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