The Effect of Femoral Nerve Block on Opioid Requirements... | NCT00175591

Studies
The Effect of Femoral Nerve Block on Opioid Requirements After Surgery for a Femur Fracture in Children

NCT00175591

Sponsor

University of British Columbia

Status

Completed

Last Update Posted

Jan 10, 2018Actual

Enrollment

25Actual

Phase

Phase 1

Conditions

Pain, Postoperative

Interventions

Administration of a femoral nerve block (bupivacaine HCL)

Countries

Canada

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

ID	Type	Description	Link
W05-0025

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 15, 2005Estimated

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

Jan 8, 2018

Last Update Posted Date

Jan 10, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kishore Mulpuri, Principle Investigator, University of British ColumbiaPrincipal Investigator

Lead Sponsor

University of British ColumbiaOTHER

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

This study evaluates the effect of a femoral nerve block on opioid requirements following femoral fracture fixation with flexible nails in the paediatric population. This is a double blind, prospective randomized clinical trial.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Administration of a femoral nerve block (bupivacaine HCL)	Procedure	No details specified

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative morphine requirement; the average 8 hour morphine requirement (mcg/kg/hr) will be recorded		until patient discharge

Secondary Outcomes

Measure	Description	Time Frame
Pain rating		immediately post-op
Sedation/pruritis/nausea/vomiting/urinary retention/respiratory rate		every 8 hours
Time to discharge

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Femoral shaft fracture requiring intra-medullary nailing
Surgery performed within 24 hours of injury
Ability of child or family to use patient-controlled analgesia (PCA)
No allergy or sensitivity to bupivacaine
Informed consent and assent

Exclusion Criteria:

Open femur fractures
Closed fractures needing open reduction
Fractures associated with neurovascular complications
Fractures associated with compartment syndrome
Repeat femoral surgeries
Patients who received a femoral nerve block more than 1 hour prior to surgery
Complex associated injuries or pre-existing condition that will delay time to ambulation
Children who are allergic and/or sensitive to bupivacaine

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kishore Mulpuri, MD	University of British Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
British Columbia Children's Hospital, Department of Orthopaedics		Vancouver	British Columbia	V6H 3V4	Canada

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative
D005264	Femoral Fractures

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

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