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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Mount Sinai School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01256281
First received: December 7, 2010
Last updated: October 2, 2012
Last verified: October 2012

December 7, 2010
October 2, 2012
September 2010
January 2014   (final data collection date for primary outcome measure)
pain score in legs (0-10) [ Time Frame: 2-4 hours after intervention ] [ Designated as safety issue: No ]
Pain score in legs at 2-4 hours after intervention will be the primary outcome. However the study is not designed to test this. The study's primary purpose is to see if the intervention is feasible.
Same as current
Complete list of historical versions of study NCT01256281 on ClinicalTrials.gov Archive Site
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Regional Anesthesia for Sickle Cell Crisis Using Ultrasound in The Emergency Department: Phase I
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.

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.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Sickle Cell Disease
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.
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.
Intervention: Procedure: Femoral Nerve Block
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
6
January 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United States
 
NCT01256281
10-0934
Yes
Mount Sinai School of Medicine
Mount Sinai School of Medicine
Not Provided
Principal Investigator: Jeffrey D Glassberg, MD Mount Sinai School of Medicine
Mount Sinai School of Medicine
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP