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Video-assisted Thoracic Surgery (VATS)NCT05038956

Serum Bupivacaine Concentration Levels After Intermittent Bolus Injections Via Erector Spinae Plane Peripheral Catheter

An observational study of Video-assisted Thoracic Surgery (VATS), run by University of Utah at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to evaluate the serum bupivacaine concentrations over time after 0.125% bupivacaine is deposited every 6 hours in the erector spinae plane in patients who undergo unilateral VATS. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Video-assisted Thoracic Surgery (VATS)
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Jan 2025to 1 Nov 2025
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients who are having unilateral video assisted thorascopic surgery at the University of Utah or Huntsman Hospital

Who may be able to join

  • at least 18 years of age
  • having a unilateral video assisted thorascopic surgery who have preoperative placement of an erector spinae plane catheter.

Who cannot join

  • Known hepatic dysfunction or renal insufficiency (creatinine >1.5 mg/dL)
  • allergy to the study medication
  • pregnancy
  • incarceration
  • inability to communicate with the investigators
  • morbid obesity (body mass index >40 mg/m2).

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Utah

    Salt Lake City, Utah, 84132

Other trials in United States

About this study

Official title: Serum Bupivacaine Concentration Levels After Intermittent Bolus Injections Through Erector Spinae Plane Peripheral Catheter

The purpose of this study is to evaluate the serum bupivacaine concentrations over time after 0.125% bupivacaine is deposited every 6 hours in the erector spinae plane in patients who undergo unilateral VATS.

Read the detailed description

Pain control is an important aspect of recovery for patients who undergo thoracic surgery. Over the past several decades, thoracic surgery has shifted from open thoracotomies to video-assisted thoracic surgery (VATS) with the result of less morbidity, fewer postoperative complications and less postoperative pain compared to open thoracic procedures. However, postoperative acute and chronic thoracic pain remain a main clinical issue with VATS and contributes to patient suffering as well as the ability to meet early rehabilitation goals. Chest wall pain has traditionally been managed with epidural analgesia and/or by narcotic medication administration (such as morphine, hydromorphone and oxycodone). These modalities, however, carry a high risk of serious effects such as epidural hematomas, dural puncture, pneumothorax, hypotension, infection as well as cough suppression, constipation, drowsiness and mental status changes. Additionally, patients who are on anticoagulants or antiplatelet therapy may not be eligible for epidural analgesia. Furthermore, the short- and long-term analgesic benefits of epidural analgesia has been shown to be inconsistent in the setting of VATS.

A relatively new technique used for post-operative pain control in thoracic surgery is the use of fascial plane blocks, specifically the erector spinae plane block (ESPB). The ESPB was first described in 2016 by Forero et al. in 4 case reports: 2 patients with chronic thoracic neuropathic pain and 2 patients with acute postoperative chest wall pain 8. Since that time the ESPB has been widely adopted as a regional technique used in thoracic, breast, abdominal and lumbar surgery. This block is achieved by depositing long-acting local anesthetic medication in the fascial plane deep to the erector spinae muscles and superficial to the transverse process, to achieve a distribution along several vertebral rami of the spinal nerves and intercostal spaces. Radiographic evidence suggests that local anesthetic injected at the ESP spreads both cranially and caudally as the plane is continuous along the vertebral column. These rami carry visceral motor, somatic motor and sensory information to and from the skin and deep muscles of the back.

In thoracic surgery, the ESPB has shown to decrease opioid consumption and pain scores in patients who undergo VATS within the first 24 hours when compared to no block and also when compared to other fascial plane blocks such as the serratus plane block. In the literature thus far, complications are rare.

Although the literature has quickly grown regarding erector spinae blocks over the last four years, specific information regarding dosing regimens for both single injection and intermittent bolus dosing through an erector spinae catheter remains limited. Most of the current information from the erector spinae block lies in case reports. In reviews of the current practices, it appears that ropivacaine and bupivacaine are the most commonly used local anesthetics with injection volumes ranging from 20 mL to 40 mL and concentrations ranging from 0.25%-0.5%. Most case reports describe single injection, while approximately 20% describe dosing either intermittently or continuously through a catheter. It is thought that because this block is a fascial plane block its' success depends, in part, on the volume and concentration of local anesthetic injected in the erector spinae plane to achieve maximal craniocaudal dermatomal distribution. It is in these scenarios that clinicians must balance achieving maximal analgesic benefit from this block with safety concerns for local anesthetic systemic toxicity (LAST).

There are no documented cases described of a patient experiencing LAST from an erector spinae block or erector spinae nerve catheter, however there is some information regarding the safety of similar fascial plane blocks. Convulsions following bilateral ultrasound guided transversus abdominis plane blocks following cesarean analgesia have been described. Trabelsi et al. describe the pharmacokinetics of bupivacaine after bilateral transversus abdominis plane blocks and found that mean peak serum bupivacaine concentrations was 30 minutes from the time of injection. However, during this study, three subjects had serum bupivacaine concentrations above the quoted toxic threshold. Furthermore, data analyzing serum concentration of local anesthetic overtime through the use of catheters is also lacking. In a study of pediatric patients with continuous paravertebral infusions it was found that serum concentration of bupivacaine was >3 mcg/mL in several infants at 30-48 hours. These studies emphasize the need for better understanding local anesthetic uptake from fascial planes blocks.

In prior studies that have attempted to illustrate the pharmacokinetics of local anesthetic uptake to serum concentrations, data has been scattered to such a degree that the investigators cannot accurately extrapolate trends. A previous study at our institution measured serum ropivacaine levels following local infiltration in the knee joint and found max serum concentrations ranging from 4 to 24 hours. In an observational study examining the pharmacokinetics of liposomal bupivacaine placed in the intercostal space, maximal serum levels ranged from 15 minutes to 48 hours. In a study analyzing the pharmacokinetics of bupivacaine following bilateral transversus abdominis plane blocks, all individual peak plasma levels were recorded between 10 and 90 minutes. With this proposed observational study, the investigators expect to see scattered data which is why the need for such tight time intervals of measurements and the amount of measurements. Besides looking at the maximum serum concentration of bupivacaine following the boluses, an additional important aspect of this observational study is to see if there is a stacking effect of plasma bupivacaine levels following repeated dosing through the catheter. Taketa et al, examined serum levels following continuous infusions of local anesthetic in the paravertebral and erector spinae planes and found building serum levels with the continuous infusion. There have been no studies to analyze if there is a stacking effect of local anesthetic in serum levels following multiple intermittent bolus doses.

Currently, no publication exists that report serum bupivacaine concentration over time following initial bolus in the erector spinae plane or following intermittent boluses of erector spinae plane catheters. This information is important to ensure that safe serum bupivacaine concentrations are maintained when considering optimal bolus dosing and intervals for erector spinae plane catheters. The current practice at the University of Utah is to bolus 25 mg of bupivacaine hydrochloride (HCL) (20 mL of 0.125% bupivacaine) through erector spinae catheters every six hours. Occasionally this regimen is ineffective and the investigators consider increasing the concentration, volume or decreasing the interval of bupivacaine administration in order to obtain better postoperative analgesia. However, increasing bupivacaine dosing also increases the risk of local anesthetic toxicity. Striking the appropriate balance between safety and maximally effective postoperative analgesia has been clinically challenging for our regional anesthesiologists and for subject experts across the world. There are no consensus data on the effective-safe dosing of these catheters. Having this knowledge will help ensure a safe practice of local anesthetic usage for unilateral thoracic surgeries.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in pharmacokinetics of bupivacaine placed in the erector spinae plane between 6 time points

    Each participant will have 5 mL of venous blood drawn to assess serum bupivacaine levels

    Measured: 30, 60, 90, 120, 240 and 360 minutes following the initial, 2nd and 5th boluses.

Secondary outcomes (1)
  1. Change in stacking effect of plasma bupivacaine levels between 6 time points

    Each participant will have 5 mL of venous blood drawn

    Measured: 30, 60, 90, 120, 240 and 360 minutes following the initial, 2nd and 5th boluses.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2021
  2. Study start1 Jan 2025 (estimated)
  3. Primary completion1 Oct 2025 (estimated)
  4. Study completion1 Nov 2025 (estimated)

Why it stopped: No immediate plans to start the study. Issues with testing materials.

Resources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05038956
Sponsor's protocol ID
IRB 00142099
Status last verified
Jul 2024
First submitted
3 Aug 2021
Last updated
13 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Video-assisted Thoracic Surgery (VATS), run by University of Utah 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 2 inclusion and 6 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: withdrawn, as of the sponsor's last update on 13 Feb 2025. 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.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Change in pharmacokinetics of bupivacaine placed in the erector spinae plane between 6 time points (time frame: 30, 60, 90, 120, 240 and 360 minutes following the initial, 2nd and 5th boluses.). 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 13 Feb 2025.

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