- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02210429
Supraclavicular Blocks for Post-Operative Pain Control in Supracondylar Fracture Fixation, a Retrospective Analysis of Single Shot Catheter Techniques
July 27, 2015 updated by: Ann & Robert H Lurie Children's Hospital of Chicago
We hypothesize that patients who receive a supraclavicular block via Angiocath, placed intra-operatively and dosed post-operatively following neurologic examination, will have lower pain scores, lower use of intravenous morphine equivalents in the post-anesthesia care unit, and lower rates of intervention for post-operative nausea and vomiting.
We also hypothesize that patients receiving this nerve block had the same rates of nerve damage as the patients who did not receive a block and that there will be no demonstrable safety concerns with this block.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
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
-
-
Illinois
-
Chicago, Illinois, United States, 60611-2605
- Ann & Robert H. Lurie Children's Hospital of Chicago
-
-
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
No older than 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age under 18
- Undergoing supracondylar fracture fixation in operating room
Exclusion Criteria:
- Incomplete or inaccessable chart data
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: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: IV Opioids
|
|
Active Comparator: Supraclavicular Single-Shot Block
|
|
Active Comparator: Supraclavicular Catheter
|
|
Active Comparator: Supraclavicular Angiocath
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-operative opioid use
Time Frame: 24 hours
|
Total doses
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anti-emetic drug use
Time Frame: 24 hours
|
Total doses
|
24 hours
|
Incidence of nerve damage or compartment syndrome
Time Frame: 1 month
|
Evaluated by surgeon at follow up.
|
1 month
|
Pain Score
Time Frame: 24 hours
|
Using Visual Analog Scale and FLACC pain scale (for younger children) we will compare pain scores in the various groups.
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Santhanam Suresh, MD, Ann & Robert H Lurie Children's Hospital of Chicago
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Suresh S, Sarwark JP, Bhalla T, Janicki J. Performing US-guided nerve blocks in the postanesthesia care unit (PACU) for upper extremity fractures: is this feasible in children? Paediatr Anaesth. 2009 Dec;19(12):1238-40. doi: 10.1111/j.1460-9592.2009.03182.x. No abstract available.
- Steinfeldt J, Robison T, Przybylo HJ. Placement of an US-guided supraclavicular block postoperatively in children: can we make this easy? Paediatr Anaesth. 2010 Aug;20(8):780-1. doi: 10.1111/j.1460-9592.2010.03355.x. No abstract available.
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
January 1, 2009
Primary Completion (Actual)
June 1, 2014
Study Completion (Anticipated)
November 1, 2015
Study Registration Dates
First Submitted
August 3, 2014
First Submitted That Met QC Criteria
August 4, 2014
First Posted (Estimate)
August 6, 2014
Study Record Updates
Last Update Posted (Estimate)
July 29, 2015
Last Update Submitted That Met QC Criteria
July 27, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-15849
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.
Clinical Trials on Pain, Postoperative
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Ankara City Hospital BilkentRecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | SternotomyTurkey
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Maimonides Medical CenterCompletedPOSTOPERATIVE PAINUnited States
-
University Hospital, AntwerpUnknown
-
Aydin Adnan Menderes UniversityCompleted
-
Aydin Adnan Menderes UniversityCompletedAcute Postoperative Pain | Chronic Postoperative PainTurkey
-
VA Office of Research and DevelopmentRecruitingTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty (Postoperative Pain)United States
-
VA Office of Research and DevelopmentCompletedTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty(Postoperative Pain)United States
Clinical Trials on Elbow Fracture Fixation
-
The Affiliated Nanjing Drum Tower Hospital of Nanjing...CompletedPosterior Malleolus FracturesChina
-
Aesculap AGCompletedThoracic Fracture | Lumbar FractureGermany
-
OrthoMediTecSuspended
-
Assiut UniversityNot yet recruitingAnkle Injuries | Ankle Fractures | Arthroscopic Surgery
-
Balgrist University HospitalUniversity of ZurichTerminatedFracture of Clavicle | Fracture of Femur | Fracture of Humerus | Fracture of Ulna Radius | Fracture of Hand | Fracture of Pelvis | Fracture of Tibia Fibula | Fracture of SkullSwitzerland
-
University of Texas Southwestern Medical CenterMedtronicCompletedLumbar Vertebral FractureUnited States
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldCompleted
-
University of Turin, ItalyRecruitingProximal Humeral FracturesItaly
-
Cairo UniversityUnknown
-
University of Maryland, BaltimoreIndiana University HealthCompletedLC Pelvic FractureUnited States