Skip to main content
OpenTrials
Completed

NCT Number: NCT04807504

Ropivacaine Pharmacokinetics in ESP Blocks

This is a pharmacokinetic study to determine risk of local anesthetic systemic toxicity of ropivacaine when used in erector spinae plane blocks for thoracic surgery. Through serial blood sampling and the use of NONMEM population pharmacokinetic analysis this risk will be determined for the study population and other populations as well. Pain and quality of recovery will also be assessed.The erector spinae plane (ESP) block was first described in 2016 as a novel fascial plane block that provided analgesia for thoracic neuropathic pain. Since then hundreds of articles have been published that have reported use of the ESP block for indications such as rib fractures, breast surgery, abdominal surgery, and even shoulder surgery. It has also been studied in thoracic surgery and clinical experience confirms that patients undergoing video-assisted thoracoscopic surgery (VATS) or robot-assisted thoracic surgery experience satisfactory analgesia with ESP blocks. Because the block location is further from the neuraxis than both epidural and paravertebral blocks, ESP blocks have been suggested as a safer alternative to these older blocks but safety data have not yet been generated. In particular, the risk of local anesthetic systemic toxicity (LAST) has not been studied in ESP blocks. While the pharmacokinetics of ropivacaine used for thoracic paravertebral blocks have been established, similar studies have yet to be performed for the newer ESP block. Of particular concern for ESP blocks are two factors not present in some other blocks with established safety: 1). significant intercostal spread has been noted in anatomical studies, which could put patients at risk for LAST and 2). some of the proposed dosing regimens involve the intermittent injection of large bolus doses of local anesthetic. While measurement of arterial plasma levels is useful and necessary to study the safety of ropivacaine given in ESP blocks, the measurements alone do not allow for prediction of plasma levels that would occur in populations as a whole. Nonmem is a population pharmacokinetic application that provides estimates of mean parameters and residual variability in pharmacokinetic values across populations and has been shown to generate better estimates than the two-stage approach. Nonmem will be used in this study to predict pharmacokinetics in populations with different characteristics than the one being studied here, which would create generalizable results.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

About this study

The erector spinae plane (ESP) block was first described in 2016 as a novel fascial plane block that provided analgesia for thoracic neuropathic pain. Since then hundreds of articles have been published that have reported use of the ESP block for indications such as rib fractures, breast surgery, abdominal surgery, and even shoulder surgery. It has also been studied in thoracic surgery and our clinical experience confirms that patients undergoing video-assisted thoracoscopic surgery (VATS) or robot-assisted thoracic surgery experience satisfactory analgesia with ESP blocks. Because the block location is further from the neuraxis than both epidural and paravertebral blocks, ESP blocks have been suggested as a safer alternative to these older blocks but safety data have not yet been generated. In particular, the risk of local anesthetic systemic toxicity (LAST) has not been studied in ESP blocks. While the pharmacokinetics of ropivacaine used for thoracic paravertebral blocks have been established, similar studies have yet to be performed for the newer ESP block. Of particular concern for ESP blocks are two factors not present in some other blocks with established safety: 1). significant intercostal spread has been noted in anatomical studies, which could put patients at risk for LAST and 2). some of the proposed dosing regimens involve the intermittent injection of large bolus doses of local anesthetic. While measurement of arterial plasma levels is useful and necessary to study the safety of ropivacaine given in ESP blocks, the measurements alone do not allow for prediction of plasma levels that would occur in populations as a whole. Nonmem is a population pharmacokinetic application that provides estimates of mean parameters and residual variability in pharmacokinetic values across populations and has been shown to generate better estimates than the two-stage approach. Nonmem will be used in this study to predict pharmacokinetics in populations with different characteristics than the one being studied here, which would create generalizable results.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • undergoing robotic or video-assisted thoracic surgery
  • able to speak English

Exclusion criteria

  • active liver disease
  • active renal disease
  • ropivacaine allergy

Treatment and study plan

Ropivacaine

Drug

All patients receive erector spinae plane blocks with ropivacaine.

Other names: Naropin

Primary outcomes

  1. Mean maximum plasma concentration of ropivacaine

    Time frame: 24 hours

Secondary outcomes

  1. Mean pain scores

    Time frame: 24 hours

    Numerical rating scale pain scores (0-10 where 0 is no pain and 10 is worst pain imaginable)

  2. Opioid consumption

    Time frame: 24 hours

    Mean amount of opioids consumed in morphine milligram equivalents

  3. Sensory levels

    Time frame: 12 hours

    Mean number of dermatomes blocked after erector spinae plane block

  4. Quality of recovery

    Time frame: 24 hours

    The mean quality of recovery 15 survey scores (0-150 where 0 is worst quality of recovery and 150 is best)

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

A Safety Study of Ropivacaine Concentrations During Continuous Erector Spinae Plane Block for Thoracic Surgery

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 19, 2021
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.