Study Measuring Total Plasma Ropivacaine Levels During Continuous Peripheral Nerve Catheter Infusion (NCT01718262)

Study 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).

Conditions studied

Anesthesia

Keywords

Ropivacaine Level
continuous peripheral nerve blocks.

In context

Lead sponsor

Defense and Veterans Center for Integrative Pain Management is the lead sponsor of 22 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 89 Years
Sexes eligible: All
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.

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

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

Observational model: Cohort
Time perspective: Prospective
Enrollment: 49 participants (actual)
Biospecimen retention: Samples without dna

What researchers measure

Primary outcomes

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

Study locations

1 site

Walter Reed National Military Medical Center
Bethesda, Maryland 20889, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01718262
Lead sponsor: Defense and Veterans Center for Integrative Pain Management
Responsible party: Sponsor
First posted: Oct 31, 2012
Start date: Apr 2010
Primary completion: Nov 2011
Completion: Nov 2011
Last update: Aug 12, 2019

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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