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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03059498
Other study ID # IRB00042325
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
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
Health authority
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:

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Study Design


Related Conditions & MeSH terms


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
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