Study Measuring Total Plasma Ropivacaine Levels During Co... | NCT01718262

Studies
Study Measuring Total Plasma Ropivacaine Levels During Continuous Peripheral Nerve Catheter Infusion

NCT01718262

Sponsor

Defense and Veterans Center for Integrative Pain Management

Status

Completed

Last Update Posted

Aug 12, 2019Actual

Enrollment

49Actual

Phase

Not provided

Conditions

Anesthesia

Interventions

Not provided

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

Aug 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

Apr 2010

Primary Completion Date

Nov 2011Actual

Completion Date

Nov 2011Actual

First Submitted Date

Oct 17, 2012

First Submission Date that Met QC Criteria

Oct 29, 2012

First Posted Date

Oct 31, 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

Aug 9, 2019

Last Update Posted Date

Aug 12, 2019Actual

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 purpose of the study is to measure the blood levels of the medicine called ropivacaine (local anesthetic) used to manage pain. Ropivacaine is a widely used medication and is not the subject of this study, but the investigators are studying how much of the drug can be found in the patient's blood, known as the blood level, of this medicine. Too much ropivacaine in a patient's blood can lead to local anesthetic toxicity. Once the nerve catheter is removed, local anesthetic toxicity is no longer a potential problem. However, there is little data on what ropivacaine blood levels are after having the catheter in for a long period of time(up to one month).

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

Retention

Enrollment

49Actual

Measure	Description	Time Frame
Plasma Ropivicaine Levels	Blood will be drawn every 0, 3, 5, 7, and 10 days. Blood is drawn every 3 days thereafter.	up to 10 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and females 18 years and older, capable of providing informed consent indicating awareness of the investigational nature of the study, in keeping with institutional policy
Written informed consent must be obtained from each patient prior to entering the study
Patients must be scheduled to receive a continuous peripheral nerve catheter

Exclusion Criteria:

Refusal to have serial blood drawn
Contraindication for a continuous peripheral nerve catheter (allergy to local anesthetic, infection at site of injection, elevated coagulation times (international normalized ratio (INR)>1.5, partial thromboplastin time (PTT)>38; these values are drawn as part of routine standard of care and those values will be checked prior to initial catheter insertion), therapeutic dosing of anticoagulation medication, moderate to severe head injury and moderate to severe traumatic brain injury
Patients with a hematocrit < 20. Complete Blood Counts (CBCs) are drawn as part of routine standard of care and will be followed by the Acute Pain Service. Although the CBCs and ropivacaine blood draws will not always coincide, we will always check the last hematocrit obtained prior to our blood draw
Severe liver or renal disease (values greater than two times normal range)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Military health care beneficiaries age 18 years and older presenting for upper or lower extremity surgery requiring continuous infusions of local anesthetic either at WRNMMC will be asked to participate in the study. We will recruit up to fifty patients for the study at WRNMMC.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Walter Reed National Military Medical Center		Bethesda	Maryland	20889	United States

Description

The plasma ropivacaine samples will be assayed at the Department of Research Programs Laboratory (DRP) at WRNMMC. Once the whole blood sample has been centrifuged, the plasma will be removed with a glass pipette, placed in a storage container. The blood samples will be labeled with a non sequential serial number and will not include the time of the blood draw. This will blind the DRP laboratory to the patient's identity and timing of the blood draw.