PECS Block: Plasma Bupivacaine Level

October 14, 2021 updated by: Wake Forest University Health Sciences

Determining Plasma Bupivacaine Levels Following Pectoral Nerve Blocks: A Prospective Observational Study

The purpose of this study is to determine peak plasma bupivacaine concentrations in a similar fashion for PECS I/II blocks. The investigators hypothesis is that the mean peak plasma levels for patients undergoing PECS I/II blocks will be less than the levels reported to cause early neurotoxicity of [2.2 (0.9) micrograms/ml]6 in patients receiving intravenous bupivacaine infusions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Regional anesthesia techniques are common modalities used to provide analgesia following both upper and lower extremity surgeries. It is also often used for truncal procedures for the same purpose. A relatively new truncal block, first described in 2012 by Blanco, called the pectoralis nerve block (PECS I and II block) has been used successfully for breast surgery1-3. Despite its description and success in clinical practice, the extent of systemic absorption from this truncal plane block has not been described to date. However, in a study published in the British Journal of Anesthesia, this has been done for another truncal plane block, the transverse abdominus plane (TAP) block where the local anesthetic was noted to peak and had a mean total concentration of ropivacaine occurring at 30 minutes after the block4. During this study, samples were taken at 10, 20, 30, 45, 60, 90, 120, 180, and 240 minutes. The investigators anticipate that since this is a similar truncal plane block, absorption will be comparable in terms of timing. However, the concentration of drug absorbed may be different given the proximity to the ribs, intercostal and thoracic vasculature, and a higher concentration of local given the smaller plane for local anesthetic spread. Given that the investigators want to find the peak of the curve and the peak concentration of bupivacaine from the PECS block, the investigators feel will need 5 samples at the times outlined below. This number of samples was chosen to approximate a study published in 2004 where ten subjects received ropivacaine for scalp blocks and serum ropivacaine levels were measured at 15, 30, 45, 60, 90, and 120 minutes5. The investigators feel that the 120 minute measurement is well beyond the peak plasma level of bupivacaine given the findings in the TAP and scalp studies. Therefore,the investigators will collect the following samples at these times after the block is completed: 5, 10, 20, 40, 60, and 90 minutes. The purpose of this study is to determine peak plasma bupivacaine concentrations in a similar fashion for PECS I/II blocks. The investigators hypothesis is that the mean peak plasma levels for our patients undergoing PECS I/II blocks will be less than the levels reported to cause early neurotoxicity of [2.2 (0.9) micrograms/ml]6 in patients receiving intravenous bupivacaine infusions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients receiving a unilateral PECS I and II block for any surgery being provided by Wake Forest Baptist Medical Center

Exclusion Criteria:

  • Subjects with contraindications to regional anesthesia, such as a history of allergy to amide local anesthetics,
  • presence of a progressive neurological deficit,
  • a pre-existing coagulopathy,
  • infection at site of injection.
  • or the following conditions:
  • patient receiving any other additional local anesthetic from another procedure
  • infection over site of block
  • patient refusal
  • significant renal or liver dysfunction on laboratory analysis
  • weight <60 kg
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: unilateral PECS block patients
unilateral PECS I and II block using bupivacaine
Procedure: Unilateral PECS I and II block
A truncal block called the pectoralis nerve block (PECS I and II block). Unilateral. Using Bupivacaine
Drug: Bupivacaine
Bupivacaine solution 0.25%. At the PECS I site each patient will receive 10 cc of local anesthetic solution, and at the PECS II site an additional 20 cc of local anesthetic solution will be placed.
Active Comparator: bilateral PECS block patients
bilateral PECS I and II block using bupivacaine
Drug: Bupivacaine
Bupivacaine solution 0.25%. At the PECS I site each patient will receive 10 cc of local anesthetic solution, and at the PECS II site an additional 20 cc of local anesthetic solution will be placed.
Procedure: Bilateral PECS I and II block
A truncal block called the pectoralis nerve block (PECS I and II block). Bilateral. Using Bupivacaine.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Peak plasma bupivacaine concentration
Time Frame: 90 minutes after dose
Will be determined by samples collected at these times after the block is completed: 5, 10, 20, 40, 60, and 90 minutes
90 minutes after dose
Bupivacaine mean concentration
Time Frame: 90 Minutes after dose
Calculated from samples at these times after the block is completed: 5, 10, 20, 40, 60, and 90 minutes
90 Minutes after dose
Standard deviations of plasma bupivacaine concentrations
Time Frame: 90 minutes after dose
Will be calculated using samples at these times after the block is completed: 5, 10, 20, 40, 60, and 90 minutes
90 minutes after dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rates of block success
Time Frame: 30 minutes after block
As assessed by pin prick at the mid-clavicular line overlying the pectoralis major in between the dermatomes of T2 to T4.
30 minutes after block
Rates of adequate ultrasound success of appropriate separation of the muscular layers for each block.
Time Frame: At the end of the block placement, 0 minutes timepoint.
be rated clinically on a 3 point scale: 0 = very poor spread with possible block failure, 1 = initially poor spread, but layers separated appropriately with high chance for successful block, 2 = spread clearly seen to separate muscular layers and successful block anticipated.
At the end of the block placement, 0 minutes timepoint.
Rates of symptoms of local anesthetic systemic toxicity
Time Frame: 90 minutes after block
Presence of symptoms from the end of the block to 90 minutes after the block.
90 minutes after block

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: J. Douglas Jaffe, DO, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 6, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00042325

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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