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Comparison Between Ultrasound-guided and Landmark-guided Ankle Blocks

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01684774
First Posted: September 13, 2012
Last Update Posted: September 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hillel Yaffe Medical Center
  Purpose
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.

Condition Intervention
Analgesia Drug: Bupivacaine

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • 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.

  • 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


Estimated Enrollment: 100
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
I. USG
Patients receiving Ultrasound-guided Ankle Block
Drug: Bupivacaine
II. ALG
Patients receiving Anatomic Landmark-guided Ankle Block
Drug: Bupivacaine

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult ASA I-III (American Society of Anesthesiologists classification) patients undergoing orthopedic foot operation with osteotomy
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01684774


Contacts
Contact: Leonid Reytman, MD 972-54-4226640 lrey@netvision.net.il

Locations
Israel
Hillel Yaffe Medical Center Not yet recruiting
Hadera, Israel, 38100
Sponsors and Collaborators
Hillel Yaffe Medical Center
  More Information

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01684774     History of Changes
Other Study ID Numbers: 0070-12-HYMC
First Submitted: September 10, 2012
First Posted: September 13, 2012
Last Update Posted: September 13, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents


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