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Comparison Between Ultrasound-guided and Landmark-guided Ankle Blocks

This study is not yet open for participant recruitment.
Verified September 2012 by Hillel Yaffe Medical Center
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01684774
First received: September 10, 2012
Last updated: September 12, 2012
Last verified: September 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • Surgical Anesthesia Sufficient [ Time Frame: Thirty minutes ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01684774     History of Changes
Other Study ID Numbers: 0070-12-HYMC
Study First Received: September 10, 2012
Last Updated: September 12, 2012
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on May 23, 2013