The Effect of Nerve Blockades in Addition to General Anes... | NCT01923623

Studies
The Effect of Nerve Blockades in Addition to General Anesthesia in Surgical Fixation of Ankle Fractures.

NCT01923623

Sponsor

Herlev Hospital

Status

Withdrawn

Last Update Posted

Apr 4, 2017Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Ankle Fracture in Need of Surgical Fixation

Interventions

Ropivacaine block

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

Apr 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was redesigned and taken over by a ph.D-student

Expanded Access Info

Start Date

Jul 1, 2013Actual

Primary Completion Date

Jul 1, 2013Actual

Completion Date

Jul 31, 2013Actual

First Submitted Date

Aug 13, 2013

First Submission Date that Met QC Criteria

Aug 14, 2013

First Posted Date

Aug 15, 2013Estimated

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 2, 2017

Last Update Posted Date

Apr 4, 2017Actual

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

This clinical, randomized, and controlled study will provide valuable scientific evidence regarding the effect of adding peripheral nerve blockades to general anaesthesia during ankle surgery. In particular, the investigators want to determine if the need for postoperative opioids will be reduced and whether this will lead to shorter admission to recovery room and fewer instances of side effects such as postoperative nausea and vomiting. In addition, the investigators will determine whether the functional outcome is improved i.e. faster and more successful rehabilitation. This would have profound benefits not only to the individual patient but also to society by reducing expenses during admission, the cost of sick leave etc.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Block	Experimental	Popliteal and saphenous Block with Ropivacaine	Drug: Ropivacaine block
NaCl	Placebo Comparator		Drug: Ropivacaine block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ropivacaine block	Drug		Block NaCl

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Use of Morphine		24 hours

Secondary Outcomes

Measure	Description	Time Frame
Functional rehabilitation outcome	American Orthopaedic Foot and Ankle Society (AOFAS) score	10-14 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >18 years
Patients in need of anaesthesia for operative fixation of ankle fractures.
American Society of Anesthesiologists (ASA) score 1-3.
BMI > 18 og < 35.
Oral and written consent

Exclusion Criteria:

Weight < 50kg
Allergy towards drugs used in the study
Patients for re-operation
Other fracture at the same time
Pregnancy
Daily use of opioids within two weeks before operation
Infection near the application site
Patients in need of dialysis
Patients with neuropathy in lower extremities

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rune Sort, M.D.	Herlev Hospital	Principal Investigator
Ann M. Møller, Dr.med.	Herlev Hospital	Study Director

Locations

Not provided