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Continuous Interscalene Block Results in Superior Recovery Throughout the First Postoperative Week

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ClinicalTrials.gov Identifier: NCT01881776
Recruitment Status : Completed
First Posted : June 20, 2013
Results First Posted : June 4, 2014
Last Update Posted : June 4, 2014
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Supportive Care
Conditions Postoperative Pain
Adverse Effects
Intervention Procedure: ISB
Enrollment 71
Recruitment Details St Luke’s-Roosevelt Hospital Center between August 2011 and June 2012
Pre-assignment Details One patient enrolled preferred to get SISB instead of GA and was therefore not randomized to treatment.
Arm/Group Title Single ISB (SISB) Group Continuous ISB (CISB) Group General Anesthesia (GA) Group
Hide Arm/Group Description

Patients in this group received single injection (SISB) interscalene brachial plexus block

ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.

For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.

Patients in this group received continuous (CISB) interscalene brachial plexus block

ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.

For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.

Patients in this group received general anesthesia (GA)
Period Title: Overall Study
Started 24 24 22
Completed 23 20 20
Not Completed 1 4 2
Reason Not Completed
Lost to Follow-up             1             2             1
Protocol Violation             0             2             1
Arm/Group Title Single ISB (SISB) Group Continuous ISB (CISB) Group General Anesthesia (GA) Group Total
Hide Arm/Group Description

Patients in this group received single injection (SISB) interscalene brachial plexus block

ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.

For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.

Patients in this group received continuous (CISB) interscalene brachial plexus block

ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.

For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.

Patients in this group received general anesthesia (GA) Total of all reporting groups
Overall Number of Baseline Participants 24 24 22 70
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 22 participants 70 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19
  79.2%
20
  83.3%
19
  86.4%
58
  82.9%
>=65 years
5
  20.8%
4
  16.7%
3
  13.6%
12
  17.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 24 participants 22 participants 70 participants
57  (9) 56  (10) 52  (12) 55  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 22 participants 70 participants
Female
13
  54.2%
17
  70.8%
14
  63.6%
44
  62.9%
Male
11
  45.8%
7
  29.2%
8
  36.4%
26
  37.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants 24 participants 22 participants 70 participants
24 24 22 70
1.Primary Outcome
Title Patients With Pain: Numerical Rating Scale (NRS-11(0-10): 0:no Pain and 10:Severe/Worst Pain) ≥ 4
Hide Description The effects of the three anesthetic techniques (continuous interscalene brachial plexus block (CISB), single interscalene brachial plexus block (SISB), or general anesthesia (GA)) when used intraoperatively as a sole anesthesia modality were studied on postoperative pain (highest NRS pain rating)
Time Frame throughout the first postoperative week on days 1, 2, 3, and 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single ISB (SISB) Group Continuous ISB (CISB) Group General Anesthesia (GA) Group
Hide Arm/Group Description:

Patients in this group received single injection (SISB) interscalene brachial plexus block

ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.

For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.

Patients in this group received continuous (CISB) interscalene brachial plexus block

ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.

For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.

Patients in this group received general anesthesia (GA)
Overall Number of Participants Analyzed 23 20 20
Measure Type: Number
Unit of Measure: participants
19 5 11
2.Secondary Outcome
Title Time-to-first Pain
Hide Description The effects of the three anesthetic techniques (SISB, CISB, and GA) when used intraoperatively as a sole anesthesia modality were studied on postoperative pain (time-to-first pain).
Time Frame throughout the first postoperative week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single ISB (SISB) Group Continuous ISB (CISB) Group General Anesthesia (GA) Group
Hide Arm/Group Description:

Patients in this group received single injection (SISB) interscalene brachial plexus block

ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.

For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.

Patients in this group received continuous (CISB) interscalene brachial plexus block

ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.

For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.

Patients in this group received general anesthesia (GA)
Overall Number of Participants Analyzed 23 20 20
Mean (Standard Deviation)
Unit of Measure: hours
11  (5) 26  (24) 2  (3)
3.Secondary Outcome
Title The Number of Patients Consume ≥1 Dose of Analgesics
Hide Description The effects of the three anesthetic techniques (SISB, CISB, and GA) when used intraoperatively as a sole anesthesia modality were studied on postoperative pain (analgesic consumption).
Time Frame throughout the first postoperative week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single ISB (SISB) Group Continuous ISB (CISB) Group General Anesthesia (GA) Group
Hide Arm/Group Description:

Patients in this group received single injection (SISB) interscalene brachial plexus block

ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.

For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.

Patients in this group received continuous (CISB) interscalene brachial plexus block

ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.

For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.

Patients in this group received general anesthesia (GA)
Overall Number of Participants Analyzed 23 20 20
Measure Type: Number
Unit of Measure: participants
16 12 13
4.Other Pre-specified Outcome
Title Fast-tracked Postoperative Care Unit (PACU) Bypass Patient Number
Hide Description To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using fast-tracked PACU bypass rate
Time Frame throughout the first postoperative week (how many patients left PACU immediately just after the operation)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single ISB (SISB) Group Continuous ISB (CISB) Group General Anesthesia (GA) Group
Hide Arm/Group Description:

Patients in this group received single injection (SISB) interscalene brachial plexus block

ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.

For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.

Patients in this group received continuous (CISB) interscalene brachial plexus block

ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.

For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.

Patients in this group received general anesthesia (GA)
Overall Number of Participants Analyzed 23 20 20
Measure Type: Number
Unit of Measure: participants
20 19 0
5.Other Pre-specified Outcome
Title Length of PACU Stay
Hide Description To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using length of PACU stay.
Time Frame throughout the first postoperative week (how long patients stayed in PACU just after the operation)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single ISB (SISB) Group Continuous ISB (CISB) Group General Anesthesia (GA) Group
Hide Arm/Group Description:

Patients in this group received single injection (SISB) interscalene brachial plexus block

ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.

For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.

Patients in this group received continuous (CISB) interscalene brachial plexus block

ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.

For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.

Patients in this group received general anesthesia (GA)
Overall Number of Participants Analyzed 23 20 20
Mean (Standard Deviation)
Unit of Measure: minutes
30  (42) 20  (31) 165  (118)
6.Other Pre-specified Outcome
Title Time to Discharge Home
Hide Description To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using time-to-discharge home.
Time Frame throughout the first postoperative week (how long patients stayed in the hospital (includes PACU and hospital time)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single ISB (SISB) Group Continuous ISB (CISB) Group General Anesthesia (GA) Group
Hide Arm/Group Description:

Patients in this group received single injection (SISB) interscalene brachial plexus block

ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.

For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.

Patients in this group received continuous (CISB) interscalene brachial plexus block

ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.

For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.

Patients in this group received general anesthesia (GA)
Overall Number of Participants Analyzed 23 20 20
Mean (Standard Deviation)
Unit of Measure: minutes
115  (109) 94  (55) 302  (249)
7.Other Pre-specified Outcome
Title Total Hours of Sleep
Hide Description To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using sleep duration.
Time Frame first postoperative week (on day 7)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single ISB (SISB) Group Continuous ISB (CISB) Group General Anesthesia (GA) Group
Hide Arm/Group Description:

Patients in this group received single injection (SISB) interscalene brachial plexus block

ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.

For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.

Patients in this group received continuous (CISB) interscalene brachial plexus block

ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.

For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.

Patients in this group received general anesthesia (GA)
Overall Number of Participants Analyzed 23 20 20
Mean (Standard Deviation)
Unit of Measure: hours
5  (2) 7  (1) 6  (2)
Time Frame Throughout the first postoperative week
Adverse Event Reporting Description Postoperative Dizziness, Nausea and Vomiting (PONV): All these symptoms were asked altogether to the patients and assessed only as positive or negative
 
Arm/Group Title Single ISB (SISB) Group Continuous ISB (CISB) Group General Anesthesia (GA) Group
Hide Arm/Group Description

Patients in this group received single injection (SISB) interscalene brachial plexus block

ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.

For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.

Patients in this group received continuous (CISB) interscalene brachial plexus block

ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.

For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.

Patients in this group received general anesthesia (GA)
All-Cause Mortality
Single ISB (SISB) Group Continuous ISB (CISB) Group General Anesthesia (GA) Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Single ISB (SISB) Group Continuous ISB (CISB) Group General Anesthesia (GA) Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/23 (21.74%)      0/20 (0.00%)      2/20 (10.00%)    
Gastrointestinal disorders       
PONV   5/23 (21.74%)  5 0/20 (0.00%)  0 2/20 (10.00%)  2
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Single ISB (SISB) Group Continuous ISB (CISB) Group General Anesthesia (GA) Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/23 (0.00%)      0/20 (0.00%)      0/20 (0.00%)    
1. It was difficult to keep three different groups blinded. 2. The resting and mobilization highest/worst NRS pain scores were ignored and only the highest pain scores of the postoperative days 1, 2, 3, and 7 were recorded.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr.Admir Hadzic
Organization: StLukeNY
Phone: 212-665-1400
EMail: admir@nysora.com
Layout table for additonal information
Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT01881776    
Other Study ID Numbers: 10142
First Submitted: February 26, 2013
First Posted: June 20, 2013
Results First Submitted: July 11, 2013
Results First Posted: June 4, 2014
Last Update Posted: June 4, 2014