NCT01684774

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

September 13, 2012

Status Verified

September 1, 2012

Enrollment Period

2 years

First QC Date

September 10, 2012

Last Update Submit

September 12, 2012

Conditions

Analgesia

Outcome Measures

Primary Outcomes (2)

  • Surgical Anesthesia Sufficient

    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

    Intensity of post-operative pain will be measured by a numerical scale from 0-10 by the patient

    Twenty-four hours

Study Arms (2)

I. USG

Patients receiving Ultrasound-guided Ankle Block

Drug: Bupivacaine

II. ALG

Patients receiving Anatomic Landmark-guided Ankle Block

Drug: Bupivacaine

Interventions

BupivacaineDRUG
I. USGII. ALG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult ASA I-III (American Society of Anesthesiologists classification) patients undergoing orthopedic foot operation with osteotomy

You may qualify if:

  • Patients undergoing orthopedic foot operation with osteotomy

You may not qualify if:

  • Skin infection near block injection site
  • Allergy to local anesthetics
  • Coagulopathy with INR \>1.4.
  • Dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Leonid Reytman, MD

CONTACT

972-54-4226640lrey@netvision.net.il

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2012

First Posted

September 13, 2012

Study Start

December 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

September 13, 2012

Record last verified: 2012-09

Locations

IL(1)