PECS Block: Plasma Bupivacaine Level

Nerve Blocks Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03059498
• Other study ID #: IRB00042325
• Status: Completed
• Phase: Early Phase 1
• Start date: June 6, 2017
• Est. completion date: November 15, 2017

Study information

• Verified date: October 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 15, 2017
• Est. primary completion date: November 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Nerve Blocks

Intervention

Procedure:
• Unilateral PECS I and II block
A truncal block called the pectoralis nerve block (PECS I and II block). Unilateral. Using Bupivacaine
• Bilateral PECS I and II block
A truncal block called the pectoralis nerve block (PECS I and II block). Bilateral. 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.

Locations

Country	Name	City	State
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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.
Secondary	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