Opioid Consumption After Knee Arthroscopy | NCT03299920

Studies
Opioid Consumption After Knee Arthroscopy

NCT03299920

Sponsor

Giorgio Veneziano

Status

Completed

Last Update Posted

Oct 23, 2019Actual

Enrollment

17Actual

Phase

Not Applicable

Conditions

Surgical Procedure, Unspecified
Orthopedic Disorder

Interventions

Standardized instructions
Conventional instructions

Countries

United States

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

Oct 2019

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

Sep 18, 2017Actual

Primary Completion Date

Oct 22, 2018Actual

Completion Date

Oct 28, 2018Actual

First Submitted Date

Sep 28, 2017

First Submission Date that Met QC Criteria

Sep 28, 2017

First Posted Date

Oct 3, 2017Actual

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

Oct 22, 2019

Last Update Posted Date

Oct 23, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Giorgio Veneziano, Director, Regional Anesthesia Service, Nationwide Children's HospitalSponsor-Investigator

Lead Sponsor

Giorgio VenezianoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 is a prospective, randomized trial of patients undergoing outpatient knee arthroscopy surgery and receiving a peripheral nerve block. Patients will be randomized to either receive standard discharge teaching or specialized teaching regarding pain control following a nerve block. Patients will be asked to complete a journal for 5 days recording their pain scores, opioid medication usage, and overall satisfaction with pain control at home.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Active Comparator	Patients will receive standardized instruction from a study nurse, tailored to understanding pain management after nerve blocks and maximizing utilization of non-opioid analgesics.	Other: Standardized instructions
Control	Other	Patient will receive conventional instructions on postoperative pain management.	Other: Conventional instructions

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standardized instructions	Other	Specific instructions related to peripheral nerve block.	Intervention

Measure	Description	Time Frame
Number of opioid medication doses taken		Post-op day 5

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient of age less than 20 years presenting to NCH main campus for knee arthroscopy
American Society of Anesthesiology physical status I or II

Exclusion Criteria:

Anterior cruciate ligament repair or reconstruction
Admission to hospital
Inability or refusal to receive femoral nerve blockade
Body mass index > 99 percentile
Hydrocodone allergy or intolerance
Acetaminophen allergy or intolerance
Non-steroidal anti-inflammatory allergy or intolerance
Pregnancy
Interpreter requirement
Opioid use within 3 months prior to surgery
Previous knee surgery at WSC after Jan. 1, 2017
History of opioid abuse or dependence

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

20 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Giorgio Veneziano, MD	Nationwide Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nationwide Children's Hospital		Columbus	Ohio	43205	United States

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
D009140	Musculoskeletal Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided