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

Completed

• Conditions: Anesthesia

• Registration Number: NCT01718262
• Lead Sponsor: Defense and Veterans Center for Integrative Pain Management

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 available

Study Timeline

• Study Start: 2010-04
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Study First Submitted: 2012-10-17
• Study First Submitted QC: 2012-10-29
• Study First Posted: 2012-10-31
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-09
• Last Update Posted: 2019-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States