Low Dose Interscalene and Infraclavicular Block for Humer... | NCT02756156

Studies
Low Dose Interscalene and Infraclavicular Block for Humerus Surgery

NCT02756156

Sponsor

Kahramanmaras Sutcu Imam University

Status

Unknown status

Last Update Posted

Apr 29, 2016Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Humerus Fracture

Interventions

Not provided

Countries

Not provided

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

Mar 2016

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

Apr 2016

Primary Completion Date

Aug 2016Estimated

Completion Date

Aug 2016Estimated

First Submitted Date

Mar 15, 2016

First Submission Date that Met QC Criteria

Apr 26, 2016

First Posted Date

Apr 29, 2016Estimated

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

Apr 26, 2016

Last Update Posted Date

Apr 29, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bora Bilal, Assist prof, Kahramanmaras Sutcu Imam UniversityPrincipal Investigator

Lead Sponsor

Kahramanmaras Sutcu Imam UniversityOTHER

Collaborators

Not provided

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

Combining interscalene block with infraclavicular block for humerus surgery provides a unique surgical anaesthesia and postoperative analgesia.

Detailed Description

Interscalene block provides effective surgical anaesthesia for shoulder and proximal arm surgery. However, sometimes it can be inadequate for distal arm surgery. Combining infraclavicular block with interscalene block may provide a successful surgical anaesthesia for humerus surgery.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

30Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Success rate of block	A complete sensory loss in distribution of the radial, median, ulnar, musculocutaneous and medial cutaneous nerves of the arm	10 min.- 20 min.

Secondary Outcomes

Measure	Description	Time Frame
Technique duration		5 min.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		24 hours
Complication rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients accepting peripheral nerve block technique for humerus surgery
Unilateral orthopedic humerus surgery
18 years of age or older

Exclusion Criteria:

Patients refused peripheral nerve block
Non-cooperate patients
Neuropathy of any etiology in the affected extremity

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

Patients undergoing humerus surgery.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bora Bilal, Asist. Prof.	Contact	+903442803245		bilalbora@yahoo.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006810	Humeral Fractures

Ancestor Terms

ID	Term
D001134	Arm Injuries
D014947	Wounds and Injuries
D050723	Fractures, Bone

Browse Leaves

Not provided

Browse Branches

Not provided