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Postoperative Subtenons Anesthesia for Postoperative Pain in Pediatric Strabismus Surgery

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ClinicalTrials.gov Identifier: NCT01812044
Recruitment Status : Completed
First Posted : March 15, 2013
Results First Posted : April 26, 2016
Last Update Posted : April 26, 2016
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition Strabismus
Interventions Drug: subtenons anesthetic - preservative-free bupivacaine 0.75%
Drug: topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel
Drug: topical control - 0.5 cc of Hypromellose 0.3% gel
Drug: subtenons control - 0.5 cc of Normal Saline
Enrollment 57
Recruitment Details 57 participants signed consent. 7 participants were withdrawn by PI prior to randomization.
Pre-assignment Details  
Arm/Group Title Subtenons Anesthetic and Topical Control Topical Anesthetic and Subtenons Control Topical Control and Subtenons Control
Hide Arm/Group Description

Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery

subtenons anesthetic - preservative-free bupivacaine 0.75%

topical control - 0.5 cc of Hypromellose 0.3% gel

Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery

topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel

subtenons control - 0.5 cc of Normal Saline

Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery

topical control - 0.5 cc of Hypromellose 0.3% gel

subtenons control - 0.5 cc of Normal Saline

Period Title: Overall Study
Started 17 17 16
Completed 17 17 16
Not Completed 0 0 0
Arm/Group Title Subtenons Anesthetic and Topical Control Topical Anesthetic and Subtenons Control Topical Control and Subtenons Control Total
Hide Arm/Group Description

Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery

subtenons anesthetic - preservative-free bupivacaine 0.75%

topical control - 0.5 cc of Hypromellose 0.3% gel

Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery

topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel

subtenons control - 0.5 cc of Normal Saline

Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery

topical control - 0.5 cc of Hypromellose 0.3% gel

subtenons control - 0.5 cc of Normal Saline

Total of all reporting groups
Overall Number of Baseline Participants 17 17 16 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Months
Number Analyzed 17 participants 17 participants 16 participants 50 participants
53.6
(13 to 87)
50.1
(19 to 91)
60.9
(27 to 89)
54.9
(13 to 91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 16 participants 50 participants
Female
7
  41.2%
7
  41.2%
7
  43.8%
21
  42.0%
Male
10
  58.8%
10
  58.8%
9
  56.3%
29
  58.0%
1.Primary Outcome
Title Average Pain Score Over the First 30 Post-operative Minutes Using the CHEOPS Scale
Hide Description

Pain will be assessed by a masked observer using the Children's Hospital Eastern Ontario Pain Scale (CHEOPS) scale. The CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) is a behavioral scale for evaluating postoperative pain in young children. The scale is assessed using the sum of a score for cry (1-3), facial expression (0-2), verbalization (0-2), torso (1-2), touch (1-2) and legs (1-2). The minimum score is 4, the maximum score is 13, and higher scores indicate more pain.

Pain is rated every 5 minutes for the first 30 minutes postoperatively. Each pain score collected in the first 30 minutes was averaged to calculate a per per participant average pain score over the first 30 minutes . Then each participant's per participant average pain score was combined to calculate the reported mean for “Average pain score over the first 30 post-operative minutes using the CHEOPS scale.” for each group.

Time Frame 0-30 minutes post-operative
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subtenons Anesthetic and Topical Control Topical Anesthetic and Subtenons Control Topical Control and Subtenons Control
Hide Arm/Group Description:

Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery

subtenons anesthetic - preservative-free bupivacaine 0.75%

topical control - 0.5 cc of Hypromellose 0.3% gel

Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery

topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel

subtenons control - 0.5 cc of Normal Saline

Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery

topical control - 0.5 cc of Hypromellose 0.3% gel

subtenons control - 0.5 cc of Normal Saline

Overall Number of Participants Analyzed 17 17 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.36  (0.97) 6.57  (1.06) 6.58  (0.51)
2.Secondary Outcome
Title Peak Pain Score
Hide Description

This secondary outcome will include the peak pain score for duration of follow up period. Pain will be assessed by masked observers, using the CHEOPS scale. The CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) is a behavioral scale for evaluating postoperative pain in young children. The scale is assessed using the sum of a score for cry (1-3), facial expression (0-2), verbalization (0-2), torso (1-2), touch (1-2) and legs (1-2). The minimum score is 4, the maximum score is 13, and higher scores indicate more pain.

A pain score was assessed and recorded every 5 minutes by a masked observer (clinical research coordinator) for the first 30 minutes after extubation, then every 15 minutes for the next hour, then, if applicable, hourly until discharge.

Time Frame 0-150 minutes post-operative
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subtenons Anesthetic and Topical Control Topical Anesthetic and Subtenons Control Topical Control and Subtenons Control
Hide Arm/Group Description:

Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery

subtenons anesthetic - preservative-free bupivacaine 0.75%

topical control - 0.5 cc of Hypromellose 0.3% gel

Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery

topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel

subtenons control - 0.5 cc of Normal Saline

Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery

topical control - 0.5 cc of Hypromellose 0.3% gel

subtenons control - 0.5 cc of Normal Saline

Overall Number of Participants Analyzed 17 17 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.65  (2.42) 10.47  (2.27) 9.69  (2.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Subtenons Anesthetic and Topical Control, Topical Anesthetic and Subtenons Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.035
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-value based on Wilcoxon rank sum test of difference in medians between groups.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Subtenons Anesthetic and Topical Control, Topical Control and Subtenons Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.189
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-value based on Wilcoxon rank sum test of difference in medians between groups.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Topical Anesthetic and Subtenons Control, Topical Control and Subtenons Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.298
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-value based on Wilcoxon rank sum test of difference in medians between groups.
3.Secondary Outcome
Title Total Narcotic Use During Post-operative Recovery
Hide Description This secondary outcome will include total narcotic use
Time Frame Total time in post-operative recovery - up to 6 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subtenons Anesthetic and Topical Control Topical Anesthetic and Subtenons Control Topical Control and Subtenons Control
Hide Arm/Group Description:

Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery

subtenons anesthetic - preservative-free bupivacaine 0.75%

topical control - 0.5 cc of Hypromellose 0.3% gel

Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery

topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel

subtenons control - 0.5 cc of Normal Saline

Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery

topical control - 0.5 cc of Hypromellose 0.3% gel

subtenons control - 0.5 cc of Normal Saline

Overall Number of Participants Analyzed 17 17 16
Mean (Standard Deviation)
Unit of Measure: mcg/kg
1.65  (0.61) 1.78  (0.66) 1.60  (.077)
4.Secondary Outcome
Title Negative Postoperative Behavior Score on the PHBQ (Post Hospitalization Behavioral Questionnaire)
Hide Description

This secondary outcome will determine the negative postoperative behaviors based on the PHBQ questionnaire given to the parents of the child 1 week (+/- 3 days) post-operatively.

with a score of 81 indicating no change, a score of less than 81 indicating a change for the better, and a score of over 81 indicating a change for the worse, on average, in behavior.

Lowest score 27; highest score 135

Time Frame 1 week (+/- 3 days) post operatively
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subtenons Anesthetic and Topical Control Topical Anesthetic and Subtenons Control Topical Control and Subtenons Control
Hide Arm/Group Description:

Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery

subtenons anesthetic - preservative-free bupivacaine 0.75%

topical control - 0.5 cc of Hypromellose 0.3% gel

Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery

topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel

subtenons control - 0.5 cc of Normal Saline

Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery

topical control - 0.5 cc of Hypromellose 0.3% gel

subtenons control - 0.5 cc of Normal Saline

Overall Number of Participants Analyzed 17 17 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
80.2  (7.8) 78.2  (10.9) 78.5  (12.1)
5.Secondary Outcome
Title Average Time to Discharge
Hide Description [Not Specified]
Time Frame 0-150 minutes post-operative
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subtenons Anesthetic and Topical Control Topical Anesthetic and Subtenons Control Topical Control and Subtenons Control
Hide Arm/Group Description:

Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery

subtenons anesthetic - preservative-free bupivacaine 0.75%

topical control - 0.5 cc of Hypromellose 0.3% gel

Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery

topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel

subtenons control - 0.5 cc of Normal Saline

Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery

topical control - 0.5 cc of Hypromellose 0.3% gel

subtenons control - 0.5 cc of Normal Saline

Overall Number of Participants Analyzed 17 17 16
Mean (Standard Deviation)
Unit of Measure: minutes
106  (16) 107  (25) 106  (21)
6.Secondary Outcome
Title Number of Participants With Post Operative Nausea and Vomiting
Hide Description [Not Specified]
Time Frame 0-150 minutes post-operative
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subtenons Anesthetic and Topical Control Topical Anesthetic and Subtenons Control Topical Control and Subtenons Control
Hide Arm/Group Description:

Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery

subtenons anesthetic - preservative-free bupivacaine 0.75%

topical control - 0.5 cc of Hypromellose 0.3% gel

Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery

topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel

subtenons control - 0.5 cc of Normal Saline

Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery

topical control - 0.5 cc of Hypromellose 0.3% gel

subtenons control - 0.5 cc of Normal Saline

Overall Number of Participants Analyzed 17 17 16
Measure Type: Number
Unit of Measure: participants
1 1 1
7.Secondary Outcome
Title Number of Participants Who Required Anti-emetic Medication Post-operatively
Hide Description [Not Specified]
Time Frame Total time in post-operative recovery - up to 6 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subtenons Anesthetic and Topical Control Topical Anesthetic and Subtenons Control Topical Control and Subtenons Control
Hide Arm/Group Description:

Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery

subtenons anesthetic - preservative-free bupivacaine 0.75%

topical control - 0.5 cc of Hypromellose 0.3% gel

Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery

topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel

subtenons control - 0.5 cc of Normal Saline

Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery

topical control - 0.5 cc of Hypromellose 0.3% gel

subtenons control - 0.5 cc of Normal Saline

Overall Number of Participants Analyzed 17 17 16
Measure Type: Number
Unit of Measure: participants
1 1 1
8.Secondary Outcome
Title Peak Pain Score During First 30 Minutes
Hide Description

This secondary outcome will include the peak pain score for duration of follow up period. Pain will be assessed by masked observers, using the CHEOPS scale. The CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) is a behavioral scale for evaluating postoperative pain in young children. The scale is assessed using the sum of a score for cry (1-3), facial expression (0-2), verbalization (0-2), torso (1-2), touch (1-2) and legs (1-2). The minimum score is 4, the maximum score is 13, and higher scores indicate more pain.

Pain is rated every 5 minutes for the first 30 minutes postoperatively.

Time Frame 0-30 minutes post-operative
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subtenons Anesthetic and Topical Control Topical Anesthetic and Subtenons Control Topical Control and Subtenons Control
Hide Arm/Group Description:

Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery

subtenons anesthetic - preservative-free bupivacaine 0.75%

topical control - 0.5 cc of Hypromellose 0.3% gel

Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery

topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel

subtenons control - 0.5 cc of Normal Saline

Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery

topical control - 0.5 cc of Hypromellose 0.3% gel

subtenons control - 0.5 cc of Normal Saline

Overall Number of Participants Analyzed 17 17 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.0  (1.9) 7.8  (2.4) 8.3  (2.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Subtenons Anesthetic and Topical Control Topical Anesthetic and Subtenons Control Topical Control and Subtenons Control
Hide Arm/Group Description

Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery

subtenons anesthetic - preservative-free bupivacaine 0.75%

topical control - 0.5 cc of Hypromellose 0.3% gel

Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery

topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel

subtenons control - 0.5 cc of Normal Saline

Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery

topical control - 0.5 cc of Hypromellose 0.3% gel

subtenons control - 0.5 cc of Normal Saline

All-Cause Mortality
Subtenons Anesthetic and Topical Control Topical Anesthetic and Subtenons Control Topical Control and Subtenons Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Subtenons Anesthetic and Topical Control Topical Anesthetic and Subtenons Control Topical Control and Subtenons Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Subtenons Anesthetic and Topical Control Topical Anesthetic and Subtenons Control Topical Control and Subtenons Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%)   0/16 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Laura Enyedi, M.D.
Organization: Duke University Medical Center
Phone: 919-684-2038
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01812044     History of Changes
Other Study ID Numbers: Pro00033000
First Submitted: March 13, 2013
First Posted: March 15, 2013
Results First Submitted: December 1, 2015
Results First Posted: April 26, 2016
Last Update Posted: April 26, 2016