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Comparison Between Ultrasound-guided and Landmark-guided Ankle Blocks

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ClinicalTrials.gov Identifier: NCT01684774
Recruitment Status : Unknown
Verified September 2012 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : September 13, 2012
Last Update Posted : September 13, 2012
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

Brief Summary:
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 or disease Intervention/treatment
Analgesia Drug: Bupivacaine

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : December 2012
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Bupivacaine

Group/Cohort Intervention/treatment
I. USG
Patients receiving Ultrasound-guided Ankle Block
Drug: Bupivacaine
II. ALG
Patients receiving Anatomic Landmark-guided Ankle Block
Drug: Bupivacaine



Primary Outcome Measures :
  1. 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.

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01684774     History of Changes
Other Study ID Numbers: 0070-12-HYMC
First Posted: September 13, 2012    Key Record Dates
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