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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01718262
• Other study ID #: 353368-19
• Status: Completed
• Start date: April 2010
• Est. completion date: November 2011

Study information

• Verified date: August 2019
• Source: Defense and Veterans Center for Integrative Pain Management
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anesthesia

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Defense and Veterans Center for Integrative Pain Management

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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