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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Defense and Veterans Center for Integrative Pain Management
ClinicalTrials.gov Identifier:
NCT01718262
First received: October 17, 2012
Last updated: November 14, 2012
Last verified: November 2012
  Purpose

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).


Condition
Anesthesia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study Measuring Total Plasma Ropivacaine Levels During Continuous Peripheral Nerve Catheter Infusion

Resource links provided by NLM:


Further study details as provided by Defense and Veterans Center for Integrative Pain Management:

Primary Outcome Measures:
  • Plasma Ropivicaine Levels [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
    Blood will be drawn every 0, 3, 5, 7, and 10 days. Blood is drawn every 3 days thereafter.


Biospecimen Retention:   Samples Without DNA

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.


Enrollment: 49
Study Start Date: April 2010
Study Completion Date: November 2011
  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718262

Locations
United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
Sponsors and Collaborators
Defense and Veterans Center for Integrative Pain Management
  More Information

No publications provided

Responsible Party: Defense and Veterans Center for Integrative Pain Management
ClinicalTrials.gov Identifier: NCT01718262     History of Changes
Other Study ID Numbers: 353368-19
Study First Received: October 17, 2012
Last Updated: November 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Defense and Veterans Center for Integrative Pain Management:
Ropivacaine Level
continuous peripheral nerve blocks.

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014