Nerve BlocksEarly Phase 1NCT03059498
PECS Block: Plasma Bupivacaine Level
A Early Phase 1 study testing Unilateral PECS I and II block, Bilateral PECS I and II block and Bupivacaine in people with Nerve Blocks, run by Wake Forest University Health Sciences at 1 site in United States.
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)… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nerve Blocks
- What is being tested?
- Unilateral PECS I and II block, Bilateral PECS I and II block and Bupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2017to 15 Nov 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients receiving a unilateral PECS I and II block for any surgery being provided by Wake Forest Baptist Medical Center
Who cannot join
- 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
Show all 11Show fewer
- infection over site of block
- patient refusal
- significant renal or liver dysfunction on laboratory analysis
- weight <60 kg
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the 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.
- Conditions
- Nerve Blocks
- Being tested
- Unilateral PECS I and II block, Bilateral PECS I and II block, Bupivacaine
- Keywords
- PECS I and II, PECS blocks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral PECS I and II blockProcedure or surgery
A truncal block called the pectoralis nerve block (PECS I and II block). Unilateral. Using Bupivacaine
Bilateral PECS I and II blockProcedure or surgery
A truncal block called the pectoralis nerve block (PECS I and II block). Bilateral. Using Bupivacaine.
BupivacaineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| unilateral PECS block patients | Active comparator | unilateral PECS I and II block using bupivacaine Receives: Procedure: Unilateral PECS I and II block; Drug: Bupivacaine |
| bilateral PECS block patients | Active comparator | bilateral PECS I and II block using bupivacaine Receives: Procedure: Bilateral PECS I and II block; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 90 minutes after dose
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 90 minutes after block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start6 Jun 2017
- Primary completion15 Nov 2017
- Study completion15 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve BlocksStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- J. Douglas Jaffe, DO, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059498
- Sponsor's protocol ID
- IRB00042325
- Status last verified
- Oct 2021
- First submitted
- 14 Feb 2017
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Plasma Bupivacaine Levels Following Pectoral Nerve Blocks: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03059498
- Acronym / sponsor ID
- IRB00042325
- Conditions
- Nerve Blocks
- Keywords
- PECS I and II, PECS blocks
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 15 Nov 2017 (actual)
- Study completion
- 15 Nov 2017 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| unilateral PECS block patients | Active comparator | Procedure: Unilateral PECS I and II block, Drug: Bupivacaineunilateral PECS I and II block using bupivacaine |
| bilateral PECS block patients | Active comparator | Procedure: Bilateral PECS I and II block, Drug: Bupivacainebilateral PECS I and II block using bupivacaine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients receiving a unilateral PECS I and II block for any surgery being provided by Wake Forest Baptist Medical Center
Key exclusion criteria (11 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unilateral PECS I and II blockA truncal block called the pectoralis nerve block (PECS I and II block). Unilateral. Using Bupivacaine | Procedure or surgery | unilateral PECS block patients |
| Bilateral PECS I and II blockA truncal block called the pectoralis nerve block (PECS I and II block). Bilateral. Using Bupivacaine. | Procedure or surgery | bilateral PECS block patients |
| BupivacaineBupivacaine 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. | Drug | bilateral PECS block patients, unilateral PECS block patients |
Primary outcome
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
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
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
3 secondary outcomes
Rates of block success
Time frame: 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.
Rates of symptoms of local anesthetic systemic toxicity
Time frame: 90 minutes after block
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Douglas Jaffe, DO principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Unilateral PECS I and II block, Bilateral PECS I and II block and Bupivacaine in people with Nerve Blocks, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak plasma bupivacaine concentration (time frame: 90 minutes after dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.