PharmacokineticsNCT03841409
Peak Plasma Levels of Bupivacaine After an Erector Spinae Block (ESP)
An observational study of Pharmacokinetics and Anesthesia, Local, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
The primary objective of the study is to measure plasma levels of bupivacaine following erector spinae (ESP) regional block in patients undergoing mastectomy. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pharmacokinetics, Anesthesia, Local
- What is being tested?
- Collection of blood samples
- Type of treatment
- Injection or infusion
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- 14 Jun 2019to 16 Oct 2019
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing unilateral mastectomy under general anesthesia and erector spinae block for post-operative pain management.
Who may be able to join
- ASA I-III
- Undergoing unilateral mastectomy under erector spinae block and general anesthesia
Who cannot join
- Patient's refusal or inability to consent
- Allergy, hypersensibility or resistance to local anesthetic
- Contra-indication to regional anesthesia: infection in the designated area, acquired or congenital coagulopathy
- Severe hepatic or renal insufficiency (GFR<30 mL/min)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4
About this study
Official title: Peak Plasma Levels of Bupivacaine After an Erector Spinae Block
The primary objective of the study is to measure plasma levels of bupivacaine following erector spinae (ESP) regional block in patients undergoing mastectomy.
Read the detailed description
Breast cancer is one of the most frequent types of cancer in women. Mastectomy is important in treating these cases; however, sometimes it is associated with acute and chronic pain. Multimodal analgesia, combining drug therapy and regional anesthesia, can help in preventing acute and perhaps chronic pain in breast cancer patients undergoing mastectomy.
Erector spinae block is a new regional anesthesia technique that has emerged to treat thoracic pain following thoracic and breast surgery. It consists of injecting local anesthetics in the space located between the erector and paravertebral muscles using ultrasound guidance. The injection can be done at the level of T5 allowing distribution of the drug to upper and lower dermatomes.
The dose of local anesthetic injected after erector spinae block should aim to maximize analgesia while minimizing the chance of toxic systemic concentrations. Defining the rate of absorption of local anesthetics into the blood after an erector spinae block will therefore help anesthesiologists determinate optimal analgesic doses, in terms of both safety and effectiveness.
This observational study will determine bupivacaine pharmacokinetics after single shot erector spinae block with bupivacaine, to further define the right dose and duration of surveillance in post-anesthesia care.
Methods:
For the erector spinae block, the patient will be placed in the sitting position. Using an ultrasound machine with a high frequency linear probe (Sonosite, HFL50 15-6MHz) placed in the parasagittal plane, 3cm away from the midline, the anesthesiologist will position an insulated hyperechoic needle (50-80 mm, 22 gauge, SonoPlex STIM, Nanoline, Pajun, Germany) at the level of the 5th thoracic vertebrae, between the erector spinae and the paravertebral muscles. The anesthesiologist will confirm the correct position of the needle with the injection of 1 mL of 5% dextrose. Then, after negative aspiration, he will inject bupivacaine 0.5% with epinephrine 5 mcg/mL in 5 ml aliquots for a total dose of 2mg/kg of ideal body weight (maximum of 150mg).
The end of injection will be considered as T0. Collection of 4.5mL of blood will be performed at T10min, T20min, T30min, T45min, T60min, T90min, T120min, T180min, and T240min.
Blood tubes will be immediately placed on ice to be ultimately sent to the laboratory for centrifugation and measurement of bupivacaine level using liquid chromatography-tandem mass spectrometry (LC-MS/MS) for each of the samples.
General anesthesia will then be induced in the operating room with no additional bupivacaine allowed by the anesthesiologist or the surgeon. After surgery, in the Post-Anesthesia Care Unit, the level of the sensory block will be identified by pinprick and the quality of analgesia will be evaluated using a verbal numerical rating scale, and opioid consumption will be noted.
- Conditions
- Pharmacokinetics, Anesthesia, Local
- Being tested
- Collection of blood samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of blood samplesOther
Nine blood samples will be collected to determine bupivacaine pharmacokinetics at T10min, T20min, T30min, T45min, T60min, T90min, T120min, T180min, and T240min. T0 will be defined as the end of bupivacaine injection.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine dosage in ESP block | The pharmacokinetics of bupivacaine 0.5% with epinephrine 5 mcg/mL for a total dose of 2mg/kg of ideal body weight following an ESP block will be determined by the collection of blood samples at predetermined time points. Receives: Other: Collection of blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal plasma concentration (Cmax) of bupivacaine after erector spinae block
The Cmax will be estimated by interpolation based on the plasmatic bupivacaine values obtained after the analysis of the blood samples.
Measured: The end of injection of bupivacaine will be considered as T0. Blood samples at T10, T20, T30, T45, T60, T90, T120, T180, and T240minutes will be collected to further analyze plasmatic bupivacaine values at these timepoints.
Secondary outcomes (4)
Time (Tmax) to maximum plasma concentration Cmax of bupivacaine
The Tmax will be estimated by interpolation based on the plasmatic bupivacaine values obtained after the analysis of the blood samples.
Measured: The end of injection of bupivacaine will be considered as T0. Blood samples at T10, T20, T30, T45, T60, T90, T120, T180, and T240minutes will be performed to further analyze plasmatic bupivacaine values at these timepoints.
Sensory block level 30 minutes after arriving to Post-Anesthesia Care Unit
Sensory block level will be measured with a 6.1g von Frey filaments.
Measured: 30 minutes after arriving to Post-Anesthesia Care Unit
Post-operative pain using verbal numerical rating scale
The quality of postoperative analgesia at rest will be evaluated with a verbal numeric scale (VNS) where 0 represents 'no pain' and 10 represents 'the worst pain'.
Measured: 30 minutes after arriving to Post-Anesthesia Care Unit
Total opioid dose needed during Post-Anesthesia Care Unit stay (PACU)
The total dose of opioids used by the patients during the PACU stay will be recorded.
Measured: After the surgery, from the entry in the Post-Anesthesia Care Unit to the discharge from the Post-Anesthesia Care Unit, for an average of one-hour stay.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start14 Jun 2019
- Primary completion16 Oct 2019
- Study completion16 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephan Williams, MD, PhD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841409
- Sponsor's protocol ID
- 18.308
- Status last verified
- Jul 2021
- First submitted
- 11 Feb 2019
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peak Plasma Levels of Bupivacaine After an Erector Spinae Block
- ClinicalTrials.gov ID
- NCT03841409
- Acronym / sponsor ID
- 18.308
- Conditions
- Pharmacokinetics, Anesthesia, Local
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 14 Jun 2019 (actual)
- Primary completion
- 16 Oct 2019 (actual)
- Study completion
- 16 Oct 2019 (actual)
- First posted
- 15 Feb 2019 (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 primary objective of the study is to measure plasma levels of bupivacaine following erector spinae (ESP) regional block in patients undergoing mastectomy.
Detailed description
Breast cancer is one of the most frequent types of cancer in women. Mastectomy is important in treating these cases; however, sometimes it is associated with acute and chronic pain. Multimodal analgesia, combining drug therapy and regional anesthesia, can help in preventing acute and perhaps chronic pain in breast cancer patients undergoing mastectomy.
Erector spinae block is a new regional anesthesia technique that has emerged to treat thoracic pain following thoracic and breast surgery. It consists of injecting local anesthetics in the space located between the erector and paravertebral muscles using ultrasound guidance. The injection can be done at the level of T5 allowing distribution of the drug to upper and lower dermatomes.
The dose of local anesthetic injected after erector spinae block should aim to maximize analgesia while minimizing the chance of toxic systemic concentrations. Defining the rate of absorption of local anesthetics into the blood after an erector spinae block will therefore help anesthesiologists determinate optimal analgesic doses, in terms of both safety and effectiveness.
This observational study will determine bupivacaine pharmacokinetics after single shot erector spinae block with bupivacaine, to further define the right dose and duration of surveillance in post-anesthesia care.
Methods:
For the erector spinae block, the patient will be placed in the sitting position. Using an ultrasound machine with a high frequency linear probe (Sonosite, HFL50 15-6MHz) placed in the parasagittal plane, 3cm away from the midline, the anesthesiologist will position an insulated hyperechoic needle (50-80 mm, 22 gauge, SonoPlex STIM, Nanoline, Pajun, Germany) at the level of the 5th thoracic vertebrae, between the erector spinae and the paravertebral muscles. The anesthesiologist will confirm the correct position of the needle with the injection of 1 mL of 5% dextrose. Then, after negative aspiration, he will inject bupivacaine 0.5% with epinephrine 5 mcg/mL in 5 ml aliquots for a total dose of 2mg/kg of ideal body weight (maximum of 150mg).
The end of injection will be considered as T0. Collection of 4.5mL of blood will be performed at T10min, T20min, T30min, T45min, T60min, T90min, T120min, T180min, and T240min.
Blood tubes will be immediately placed on ice to be ultimately sent to the laboratory for centrifugation and measurement of bupivacaine level using liquid chromatography-tandem mass spectrometry (LC-MS/MS) for each of the samples.
General anesthesia will then be induced in the operating room with no additional bupivacaine allowed by the anesthesiologist or the surgeon. After surgery, in the Post-Anesthesia Care Unit, the level of the sensory block will be identified by pinprick and the quality of analgesia will be evaluated using a verbal numerical rating scale, and opioid consumption will be noted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine dosage in ESP block | – | Other: Collection of blood samplesThe pharmacokinetics of bupivacaine 0.5% with epinephrine 5 mcg/mL for a total dose of 2mg/kg of ideal body weight following an ESP block will be determined by the collection of blood samples at predetermined time points. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing unilateral mastectomy under general anesthesia and erector spinae block for post-operative pain management.
Key inclusion criteria (2 listed)
- ASA I-III
- Undergoing unilateral mastectomy under erector spinae block and general anesthesia
Key exclusion criteria (4 listed)
- Patient's refusal or inability to consent
- Allergy, hypersensibility or resistance to local anesthetic
- Contra-indication to regional anesthesia: infection in the designated area, acquired or congenital coagulopathy
- Severe hepatic or renal insufficiency (GFR<30 mL/min)
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 |
|---|---|---|
| Collection of blood samplesNine blood samples will be collected to determine bupivacaine pharmacokinetics at T10min, T20min, T30min, T45min, T60min, T90min, T120min, T180min, and T240min. T0 will be defined as the end of bupivacaine injection. | Other | Bupivacaine dosage in ESP block |
Primary outcome
Maximal plasma concentration (Cmax) of bupivacaine after erector spinae block
Time frame: The end of injection of bupivacaine will be considered as T0. Blood samples at T10, T20, T30, T45, T60, T90, T120, T180, and T240minutes will be collected to further analyze plasmatic bupivacaine values at these timepoints.
The Cmax will be estimated by interpolation based on the plasmatic bupivacaine values obtained after the analysis of the blood samples.
4 secondary outcomes
Time (Tmax) to maximum plasma concentration Cmax of bupivacaine
Time frame: The end of injection of bupivacaine will be considered as T0. Blood samples at T10, T20, T30, T45, T60, T90, T120, T180, and T240minutes will be performed to further analyze plasmatic bupivacaine values at these timepoints.
Sensory block level 30 minutes after arriving to Post-Anesthesia Care Unit
Time frame: 30 minutes after arriving to Post-Anesthesia Care Unit
Post-operative pain using verbal numerical rating scale
Time frame: 30 minutes after arriving to Post-Anesthesia Care Unit
Total opioid dose needed during Post-Anesthesia Care Unit stay (PACU)
Time frame: After the surgery, from the entry in the Post-Anesthesia Care Unit to the discharge from the Post-Anesthesia Care Unit, for an average of one-hour stay.
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 31 May 2022.
- Individual participant dataSharing planned: Undecided
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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.
Stephan Williams, MD, PhD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pharmacokinetics and Anesthesia, Local, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 2 inclusion and 4 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 31 May 2022. 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 Canada. 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.
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?
Maximal plasma concentration (Cmax) of bupivacaine after erector spinae block (time frame: The end of injection of bupivacaine will be considered as T0. Blood samples at T10, T20, T30, T45, T60, T90, T120, T180, and T240minutes will be collected to further analyze plasmatic bupivacaine values at these timepoints.). 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 31 May 2022.