PECS Block: Plasma Bupivacaine Level

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: Completed
• Conditions: Nerve Blocks
• Intervention / Treatment: Procedure: Unilateral PECS I and II block; Drug: Bupivacaine; Procedure: Bilateral PECS I and II block

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: Interventional
• Enrollment (Actual): 20
• Phase: Early Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Peak plasma bupivacaine concentration	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	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	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

Outcome Measure	Measure Description	Time Frame
Rates of block success	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.	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	Presence of symptoms from the end of the block to 90 minutes after the block.	90 minutes after block

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: J. Douglas Jaffe, DO, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2017
• Primary Completion (Actual): November 15, 2017
• Study Completion (Actual): November 15, 2017

Study Registration Dates

• First Submitted: February 14, 2017
• First Submitted That Met QC Criteria: February 15, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 14, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: PECS I and II; PECS blocks
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID 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