- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01684774
Comparison Between Ultrasound-guided and Landmark-guided Ankle Blocks
September 12, 2012 updated by: Hillel Yaffe Medical Center
The investigators will be comparing ultrasound-guided (USG) ankle block and anatomic landmark-guided (ALG) ankle block to determine which of these procedures is better in surgical anesthesia and in postoperative pain relief.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
100
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
-
-
-
Hadera, Israel, 38100
- Hillel Yaffe Medical Center
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adult ASA I-III (American Society of Anesthesiologists classification) patients undergoing orthopedic foot operation with osteotomy
Description
Inclusion Criteria:
- Patients undergoing orthopedic foot operation with osteotomy
Exclusion Criteria:
- Skin infection near block injection site
- Allergy to local anesthetics
- Coagulopathy with INR >1.4.
- Dementia
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
I. USG
Patients receiving Ultrasound-guided Ankle Block
|
|
II. ALG
Patients receiving Anatomic Landmark-guided Ankle Block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Surgical Anesthesia Sufficient
Time Frame: Thirty minutes
|
Sufficiency of surgical anesthesia will be determined by the presence of a complete sensory or motor block.
If general anesthesia needs to be added to achieve operative analgesia, the surgical block will not be deemed sufficient.
|
Thirty minutes
|
Post-operative Pain Relief
Time Frame: Twenty-four hours
|
Intensity of post-operative pain will be measured by a numerical scale from 0-10 by the patient
|
Twenty-four hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
December 1, 2012
Primary Completion (Anticipated)
December 1, 2014
Study Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
September 10, 2012
First Submitted That Met QC Criteria
September 12, 2012
First Posted (Estimate)
September 13, 2012
Study Record Updates
Last Update Posted (Estimate)
September 13, 2012
Last Update Submitted That Met QC Criteria
September 12, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0070-12-HYMC
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.
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