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IV Steroids Versus Steroids Included in Block for Orthopedic Lower Limb Surgery

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ClinicalTrials.gov Identifier: NCT03855059
Recruitment Status : Completed
First Posted : February 26, 2019
Results First Posted : July 21, 2021
Last Update Posted : July 21, 2021
Sponsor:
Information provided by (Responsible Party):
Peter R. Lichtenthal, MD, University of Arizona

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition Lower Limb Injury
Interventions Drug: Placebos
Drug: Dexamethasone Sodium Phosphate
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervenous Steroid Perineural Steroid
Hide Arm/Group Description Steroid given intervenously at the time of Peripheral nerve block Steroid given in syringe with the local anesthetic
Period Title: Overall Study
Started 25 25
Completed 23 25
Not Completed 2 0
Arm/Group Title Intervenous Steroid Perineural Steroid Total
Hide Arm/Group Description Steroid given intervenously at the time of Peripheral nerve block Steroid given in syringe with the local anesthetic Total of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Median (Full Range)
Unit of measure:  Years
Population age Number Analyzed 25 participants 25 participants 50 participants
13.24
(6 to 18)
11.28
(7 to 20)
12.26
(6 to 20)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Female
13
  52.0%
10
  40.0%
23
  46.0%
Male
12
  48.0%
15
  60.0%
27
  54.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Analgesia Duration
Hide Description The investigator would like to investigate if the dexamethasone given IV or with the nerve block in young patients undergoing lower limb surgery produces the same duration of analgesia.
Time Frame 24 - 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervenous Steroid Perineural Steroid
Hide Arm/Group Description:
Steroid given intervenously at the time of Peripheral nerve block
Steroid given in syringe with the local anesthetic
Overall Number of Participants Analyzed 23 25
Mean (Standard Deviation)
Unit of Measure: Hours
22.1  (8.9) 25.7  (9.8)
Time Frame 6 months
Adverse Event Reporting Description Followed acutely for seven days post operative and 6 months for any post op complications
 
Arm/Group Title Intervenous Steroid Perineural Steroid
Hide Arm/Group Description Steroid given intervenously at the time of Peripheral nerve block Steroid given in syringe with the local anesthetic
All-Cause Mortality
Intervenous Steroid Perineural Steroid
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Hide Serious Adverse Events
Intervenous Steroid Perineural Steroid
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervenous Steroid Perineural Steroid
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
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: Peter Lichtenthal, MD
Organization: University of Arizona/Deptartment of Anesthesiology
Phone: 5206267221
EMail: plich@arizona.edu
Layout table for additonal information
Responsible Party: Peter R. Lichtenthal, MD, University of Arizona
ClinicalTrials.gov Identifier: NCT03855059    
Other Study ID Numbers: 02182019
First Submitted: February 25, 2019
First Posted: February 26, 2019
Results First Submitted: March 15, 2021
Results First Posted: July 21, 2021
Last Update Posted: July 21, 2021