Comparison Between Ultrasound-guided and Landmark-guided... | NCT01684774

Studies
Comparison Between Ultrasound-guided and Landmark-guided Ankle Blocks

NCT01684774

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Sep 13, 2012Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Analgesia

Interventions

Bupivacaine

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Dec 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Sep 10, 2012

First Submission Date that Met QC Criteria

Sep 12, 2012

First Posted Date

Sep 13, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2012

Last Update Posted Date

Sep 13, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
I. USG		Patients receiving Ultrasound-guided Ankle Block	Drug: Bupivacaine
II. ALG		Patients receiving Anatomic Landmark-guided Ankle Block	Drug: Bupivacaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bupivacaine	Drug		I. USG II. ALG

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Leonid Reytman, MD	Contact	972-54-4226640		lrey@netvision.net.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe Medical Center		Hadera		38100	Israel

Condition Browse Module

MeSH Terms

ID	Term
D000377	Agnosia

Ancestor Terms

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002045	Bupivacaine

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided